Trial Outcomes & Findings for GATT-Patch Versus TachoSil in Liver Surgery (NCT NCT05385952)
NCT ID: NCT05385952
Last Updated: 2026-03-04
Results Overview
Surface Bleeding Severity Scale 0
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
During surgical procedure, assessed up to 10 minutes after device application
Results posted on
2026-03-04
Participant Flow
Participant milestones
| Measure |
GATT-Patch (Currently Named ETHIZIA)
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
TachoSil
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
44
|
|
Overall Study
COMPLETED
|
79
|
41
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GATT-Patch Versus TachoSil in Liver Surgery
Baseline characteristics by cohort
| Measure |
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
TachoSil
n=43 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=41 Participants
|
63 years
n=35 Participants
|
65.5 years
n=76 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
49 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
81 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
13 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
115 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
12 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
107 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
9 Participants
n=76 Participants
|
|
Region of Enrollment
Netherlands
|
33 participants
n=41 Participants
|
17 participants
n=35 Participants
|
50 participants
n=76 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=41 Participants
|
21 participants
n=35 Participants
|
66 participants
n=76 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=41 Participants
|
5 participants
n=35 Participants
|
14 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: During surgical procedure, assessed up to 10 minutes after device applicationPopulation: Per protocol population
Surface Bleeding Severity Scale 0
Outcome measures
| Measure |
TachoSil
n=43 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Rate of Hemostasis at 3 Minutes Without Rebleeding at the 10-minute Time Point
|
33 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: During surgical procedure, assessed up to 10 minutes or up to the time that hemostasis is achieved, whichever occurred lastPopulation: Per protocol population
Surface Bleeding Severity Scale 0
Outcome measures
| Measure |
TachoSil
n=43 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Mean Time to Hemostasis (Seconds)
|
180 seconds
Interval 180.0 to 180.0
|
30 seconds
Interval 30.0 to 30.0
|
SECONDARY outcome
Timeframe: During surgical procedure, up to the time that hemostasis is achievedSurface Bleeding Severity Scale 0
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
90 seconds
|
0 Participants
|
3 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
120 seconds
|
0 Participants
|
1 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
150 seconds
|
0 Participants
|
1 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
180 seconds
|
33 Participants
|
0 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
210 seconds
|
0 Participants
|
0 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
240 seconds
|
1 Participants
|
1 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
270 seconds
|
0 Participants
|
0 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
300 seconds
|
1 Participants
|
0 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
360 seconds
|
3 Participants
|
1 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
420 seconds
|
0 Participants
|
0 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
480 seconds
|
0 Participants
|
0 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
540 seconds
|
1 Participants
|
1 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
600 seconds
|
2 Participants
|
2 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
At closure
|
3 Participants
|
1 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
30 seconds
|
0 Participants
|
66 Participants
|
|
Kaplan-Meier Estimated Distribution of Time to Hemostasis
60 seconds
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: During surgical procedurePopulation: Intention-to-treat population
SBSS 1-5 at the 10 minute timepoint
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Rate of Subjects With Treatment Failure
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During surgical procedure up to patient closurePopulation: Intention-to-treat population
Surface Bleeding Severity Scale 1-5 after initially Surface Bleeding Severity Scale 0
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Rate of Subjects With Rebleeding After 10 Minutes But Before Subject Closure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During surgical procedure up to 10 minutes after device applicationPopulation: Intention-to-treat population
Surface Bleeding Severity Scale 0-5
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 480 seconds
|
0 Participants
|
0 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 540 seconds
|
1 Participants
|
1 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 600 seconds
|
2 Participants
|
2 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Not achieved within 10 minutes
|
3 Participants
|
1 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 360 seconds
|
3 Participants
|
1 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 420 seconds
|
0 Participants
|
0 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 30 seconds
|
0 Participants
|
66 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 60 seconds
|
0 Participants
|
10 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 90 seconds
|
0 Participants
|
3 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 120 seconds
|
0 Participants
|
1 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 150 seconds
|
0 Participants
|
1 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 180 seconds
|
33 Participants
|
0 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 210 seconds
|
0 Participants
|
0 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 240 seconds
|
1 Participants
|
1 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 270 seconds
|
0 Participants
|
0 Participants
|
|
Rate of Subjects With Hemostasis at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, 420, 540 and 600 Seconds
Hemostasis achieved at 300 seconds
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During surgical procedurePopulation: Intention-to-treat population
Time in minutes
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Procedure Duration
|
211.5 Minutes
Interval 83.0 to 581.0
|
210 Minutes
Interval 21.0 to 744.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During surgical procedurePopulation: Intention-to-treat population
mL
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Estimated Blood Loss
|
425 mL
Interval 225.0 to 875.0
|
500 mL
Interval 300.0 to 1000.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During surgical procedurePopulation: Safety population
Platelets, Erythrocytes, Plasma
Outcome measures
| Measure |
TachoSil
n=43 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Number of Participants With Each Type of Blood Transfusions: Platelets, Erythrocytes, Plasma
Red blood cell
|
6 Participants
|
10 Participants
|
|
Number of Participants With Each Type of Blood Transfusions: Platelets, Erythrocytes, Plasma
Platelets
|
0 Participants
|
3 Participants
|
|
Number of Participants With Each Type of Blood Transfusions: Platelets, Erythrocytes, Plasma
Plasma
|
2 Participants
|
6 Participants
|
|
Number of Participants With Each Type of Blood Transfusions: Platelets, Erythrocytes, Plasma
None
|
35 Participants
|
68 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 daysPopulation: Intention-to-treat population
Platelets, Erythrocytes, Plasma
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Number and Type of Blood Transfusions
Red blood cell
|
3 Participants
|
13 Participants
|
|
Number and Type of Blood Transfusions
Platelets
|
0 Participants
|
2 Participants
|
|
Number and Type of Blood Transfusions
Plasma
|
0 Participants
|
4 Participants
|
|
Number and Type of Blood Transfusions
Other
|
0 Participants
|
1 Participants
|
|
Number and Type of Blood Transfusions
None
|
41 Participants
|
67 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From surgery to discharge from the ICU, estimated up to 30 daysPopulation: Intention-to-treat population
Time in hours
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Mean Duration of ICU Stay
|
24 Hours
Interval 24.0 to 24.0
|
24 Hours
Interval 24.0 to 72.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 daysPopulation: Intention-to-treat population
Time in days
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Mean Total Hospitalization Time
|
6.5 Days
Interval 5.0 to 9.0
|
7 Days
Interval 6.0 to 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During hospitalization up to hospital discharge after the surgical procedure, estimated up to 30 daysSerous, sanguineous, serosanguineous, other Sanguineous Serosanguinous Serous, Sanguineous, Serosanguineous, Purulent, Other
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: During postoperative 3-months follow-upPopulation: Intention-to-treat population
Occurrence yes/no
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Rate of Subjects Requiring Reoperation
|
2 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 6 weeks follow-up visitPopulation: Intention-to-treat population with imaging performed
Patch encapsulation, patch rolling up on the surface, pseudoaneurysm, fluid collection
Outcome measures
| Measure |
TachoSil
n=42 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=76 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Rate of Subjects With Liver Resection Surface Complications on Ultrasound
Encapsulation
|
0 Participants
|
1 Participants
|
|
Rate of Subjects With Liver Resection Surface Complications on Ultrasound
Rolled up device
|
0 Participants
|
0 Participants
|
|
Rate of Subjects With Liver Resection Surface Complications on Ultrasound
Pseudoaneurysm
|
0 Participants
|
0 Participants
|
|
Rate of Subjects With Liver Resection Surface Complications on Ultrasound
Fluid Collection
|
14 Participants
|
20 Participants
|
|
Rate of Subjects With Liver Resection Surface Complications on Ultrasound
N/A
|
28 Participants
|
55 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During surgical procedurePopulation: Intention to treat
cm2 patch per cm2 bleeding
Outcome measures
| Measure |
TachoSil
n=44 Participants
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=87 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
Amount of Hemostatic Material Needed Versus Bleeding Surface
|
11.4 Size of patch applied per cm2 bleeding
Interval 3.8 to 22.8
|
5.6 Size of patch applied per cm2 bleeding
Interval 3.1 to 12.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the surgical procedure, at day 0Population: Intention to treat with the questionnaire completed
Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome for uneven questions and (strongly) disagreeing meaning a better outcome for even questions
Outcome measures
| Measure |
TachoSil
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=83 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Agreed with "I think that I would like to use GATT-Patch frequently"
|
—
|
81 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Disagreed with "I found GATT-Patch unnecessarily complex"
|
—
|
83 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Agreed with "I thought GATT-Patch was easy to use"
|
—
|
82 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Disagreed with "I think I would need support of a technical person to use GATT-Patch"
|
—
|
83 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Agree with "I found the various functions in GATT-Patch well integrated"
|
—
|
82 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Disagreed with "I thought there was too much inconsistency in GATT-Patch"
|
—
|
82 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Agreed with "I would imagine that most people would learn to use GATT-Patch very quickly"
|
—
|
82 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Disagreed with "I found GATT-Patch very cumbersome to use"
|
—
|
81 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Agreed with "I felt very confident using GATT-Patch"
|
—
|
82 participants
|
|
System Usability Score (SUS) User Satisfaction Questionnaire
Neutral/Disagreed with "I needed to learn a lot of things before I could get going with GATT-Patch"
|
—
|
82 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At completion of the surgical procedure, at day 0Population: Intention to treat with questionnaire completed
Likert scale (strongly disagree, disagree, neutral, agree, strongly agree) with (strongly) agreeing meaning a better outcome
Outcome measures
| Measure |
TachoSil
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
GATT-Patch (Currently Named ETHIZIA)
n=82 Participants
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
|---|---|---|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "I feel confident that GATT-Patch stops a bleeding"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "I feel confident that GATT-Patch can be used safely"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "GATT-Patch is easy to be used/handled"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear what to do with the Implant Card (only applicable for patients in EU)"
|
—
|
37 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "The packaging is easy to open without damaging GATT-Patch"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "The size of GATT-Patch is adequate for its intended purpose"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "A dry GATT-Patch does not stick to dry gloves and instruments"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "GATT-Patch is easy to cut with dry scissors"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "GATT-Patch can be handled with dry tweezers without damaging/fragmenting"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear that GATT-Patch should be applied with a wet gauze for a period of 30s"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear that GATT-Patch should be applied overlapping the bleeding by 1 cm"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "GATT-Patch is pliable on irregular tissue when applied with a wet gauze"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "The wet gauze can be carefully and safely removed without damaging GATT-Patch"
|
—
|
79 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "GATT-Patch stays in place after application"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is easy to ensure that GATT-Patch is fully hydrated after application"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear how to apply a GATT-Patch (partly) on top of another GATT-Patch"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "The maximum number of GATT-Patches used in a patient is clear"
|
—
|
78 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "The blue color helps to visualize GATT-Patch after application"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "Safe to remove excess non-adherent GATT-Patch without damaging adherent GATT-Patch"
|
—
|
79 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "GATT-Patch can be used intuitively"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "On the non-sterile packaging of GATT-Patch it is clear what storage conditions are"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "On the packaging of GATT-Patch, it is clear what the expiration date is"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear how to safely open the packaging, without damaging GATT-Patch"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear that GATT-Patch should be used within 1 hour after opening the blister"
|
—
|
73 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear on which organs GATT-Patch is allowed to be used"
|
—
|
82 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear on which organs GATT-Patch is not allowed to be used"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear for what severity of bleeding GATT-Patch can be used"
|
—
|
80 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "It is clear what contraindications of a patient prohibit use of GATT-Patch"
|
—
|
81 participants
|
|
GATT-Patch Device-specific User Satisfaction Questionnaire
Neutral/Agree "The information in the instructions for use is sufficient"
|
—
|
82 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsOccurrence yes/no
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsOccurrence yes/no
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 yearsOccurrence yes/no
Outcome measures
Outcome data not reported
Adverse Events
GATT-Patch (Currently Named ETHIZIA)
Serious events: 37 serious events
Other events: 66 other events
Deaths: 5 deaths
TachoSil
Serious events: 10 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
GATT-Patch (Currently Named ETHIZIA)
n=87 participants at risk
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
TachoSil
n=43 participants at risk
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Septic shock
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Intra abdominal fluid collection
|
9.2%
8/87 • Number of events 8 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Ascites
|
3.4%
3/87 • Number of events 3 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
2.3%
2/87 • Number of events 2 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.3%
2/87 • Number of events 2 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/87 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
17.2%
15/87 • Number of events 15 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
4.7%
2/43 • Number of events 2 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Abdominal abscess
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/87 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Cellulitis
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Infectious pleural effusion
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Liver abscess
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Pneumonia
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Postoperative abscess
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
2/87 • Number of events 2 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
4.7%
2/43 • Number of events 2 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/87 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Cardiac disorders
Myocardial ischaemia
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
General disorders
Multiple organ dysfunction syndrome
|
3.4%
3/87 • Number of events 3 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
General disorders
Chest pain
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
General disorders
Systemic inflammatory response syndrome
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
2/87 • Number of events 2 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/87 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Renal and urinary disorders
Renal tubular necrosis
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.00%
0/87 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/87 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Hepatobiliary disorders
Bile duct stenosis
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Hepatobiliary disorders
Cholangitis
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Hepatobiliary disorders
Hepatic failure
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/87 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Psychiatric disorders
Delirium
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Vascular disorders
Lymphatic fistula
|
1.1%
1/87 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
Other adverse events
| Measure |
GATT-Patch (Currently Named ETHIZIA)
n=87 participants at risk
Hemostatic patch
GATT-Patch (currently named ETHIZIA): GATT-Patch (currently named ETHIZIA) is a sterile, flexible and resorbable hemostatic sealing patch. It presents as a blue, soft, flexible, porcine gelatin fiber-based carrier impregnated with an NHS-POx / NU-POx granulate. GATT-Patch measures 10 cm long by 5 cm wide. GATT-Patch is active and can be applied on both sides. Blue color is an aid to visualize GATT-Patch when applied onto a bleeding location.
GATT-Patch is indicated for use as an adjunct to hemostasis in surgery for minimal, mild or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. GATT-Patch is intended to be used for management of hemorrhage during surgeries on the liver.
|
TachoSil
n=43 participants at risk
Hemostatic patch
TachoSil: TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
9.2%
8/87 • Number of events 9 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
11.6%
5/43 • Number of events 6 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Vascular disorders
Vascular disorders
|
10.3%
9/87 • Number of events 9 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
7.0%
3/43 • Number of events 4 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Psychiatric disorders
Psychiatric disorders
|
6.9%
6/87 • Number of events 7 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
0.00%
0/43 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
11.5%
10/87 • Number of events 10 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
11.6%
5/43 • Number of events 5 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Gastrointestinal disorders
Nausea
|
6.9%
6/87 • Number of events 6 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
7.0%
3/43 • Number of events 3 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
23.0%
20/87 • Number of events 20 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
9.3%
4/43 • Number of events 4 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.7%
5/87 • Number of events 5 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
7.0%
3/43 • Number of events 3 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.8%
12/87 • Number of events 12 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
14.0%
6/43 • Number of events 7 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.9%
6/87 • Number of events 6 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Infections and infestations
Infections and infestations
|
26.4%
23/87 • Number of events 30 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
11.6%
5/43 • Number of events 7 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
5.7%
5/87 • Number of events 5 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
23.3%
10/43 • Number of events 10 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
General disorders
Impaired healing
|
5.7%
5/87 • Number of events 5 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
2.3%
1/43 • Number of events 1 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Investigations
Investigations
|
12.6%
11/87 • Number of events 12 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
11.6%
5/43 • Number of events 10 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Renal and urinary disorders
Renal and urinary disorders
|
10.3%
9/87 • Number of events 9 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
14.0%
6/43 • Number of events 6 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
|
Cardiac disorders
Atrial fibrillation
|
6.9%
6/87 • Number of events 7 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
7.0%
3/43 • Number of events 3 • 3 months
ISO14155 and FDA definitions for AEs and SAEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place