Trial Outcomes & Findings for The Fibrin Pad CV Phase III Study (NCT NCT02040428)
NCT ID: NCT02040428
Last Updated: 2017-08-15
Results Overview
Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
156 participants
Primary outcome timeframe
Intraoperative, 3 minutes following treatment application
Results posted on
2017-08-15
Participant Flow
Subjects were recruited from January 13, 2014 through September 23, 2015 at hospitals and medical centers throughout the United States, United Kingdom, Belgium, Japan and Australia.
One subject was randomized to EVARREST, but instead received TachoSil; and analyzed in EVARREST ITT set and in TachoSil group for Safety set. Therefore, Safety set consists of 75 subjects in EVARREST arm and 81 subjects in TachoSil arm, while the ITT set consists of 76 subjects in EVARREST arm and 80 subjects in TachoSil arm.
Participant milestones
| Measure |
EVARREST Fibrin Sealant Patch
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
81
|
|
Overall Study
Intent to Treat (Randomized Subjects)
|
76
|
80
|
|
Overall Study
COMPLETED
|
70
|
77
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
EVARREST Fibrin Sealant Patch
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
|---|---|---|
|
Overall Study
Death
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
The Fibrin Pad CV Phase III Study
Baseline characteristics by cohort
| Measure |
EVARREST Fibrin Sealant Patch
n=75 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
n=81 Participants
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Customized
Between 18 < 50 years
|
14 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Age, Customized
50 < 65 years
|
21 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
53 Participants
n=35 Participants
|
|
Age, Customized
65 < 75
|
22 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
|
Age, Customized
>= 75
|
18 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=39 Participants
|
61 Participants
n=41 Participants
|
117 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=39 Participants
|
76 Participants
n=41 Participants
|
144 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
62 Participants
n=39 Participants
|
66 Participants
n=41 Participants
|
128 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
BMI Category
Underweight
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
BMI Category
Normal
|
20 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
BMI Category
Overweight
|
31 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
|
BMI Category
Obese
|
20 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
|
BMI Category
Morbidly obese
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Intraoperative, 3 minutes following treatment applicationPopulation: The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set, consisting of all randomized subjects.
Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=76 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
n=80 Participants
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
|---|---|---|
|
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
|
57 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Intraoperative, 6 minutes following treatment applicationPopulation: The secondary endpoint analyses were based on the Intent to Treat (ITT) analysis set.
The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=76 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
n=80 Participants
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
|---|---|---|
|
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
|
59 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Intraoperative, 10 minutes following treatment applicationThe number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=76 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
n=80 Participants
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
|---|---|---|
|
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
|
64 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Intra-operative, prior initiation of final chest wall closure.The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS
Outcome measures
| Measure |
EVARREST Fibrin Sealant Patch
n=76 Participants
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
n=80 Participants
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
|---|---|---|
|
Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
|
5 Participants
|
4 Participants
|
Adverse Events
EVARREST Fibrin Sealant Patch
Serious events: 31 serious events
Other events: 73 other events
Deaths: 0 deaths
TachoSil
Serious events: 34 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVARREST Fibrin Sealant Patch
n=75 participants at risk
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
n=81 participants at risk
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Atrial fibrillation
|
9.3%
7/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
9.9%
8/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Atrioventricular block complete
|
2.7%
2/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Cardiac arrest
|
2.7%
2/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Cardiac tamponade
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
2.5%
2/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Cardiogenic shock
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Myocardial depression
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
3.7%
3/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Right ventricular failure
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
General disorders
Chest pain
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
General disorders
Multi-organ failure
|
2.7%
2/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
General disorders
Pyrexia
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
General disorders
Systemic inflammatory response syndrome
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Appendicitis
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Cellulitis
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Pneumonia
|
2.7%
2/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
3.7%
3/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Postoperative wound infection
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Wound infection
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
5.3%
4/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
4.9%
4/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Investigations
Anticoagulation drug level above therapeutic
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Investigations
International normalised ratio fluctuation
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Nervous system disorders
Brain injury
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
2.5%
2/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Nervous system disorders
Convulsion
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Nervous system disorders
Presyncope
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Renal and urinary disorders
Renal failure
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
2.5%
2/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
2.5%
2/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.0%
6/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
8.6%
7/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/75 • Number of events 1 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
3.7%
3/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
2.7%
2/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Vascular disorders
Hypertension
|
0.00%
0/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Vascular disorders
Jugular vein thrombosis
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Vascular disorders
Venous thrombosis limb
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
Other adverse events
| Measure |
EVARREST Fibrin Sealant Patch
n=75 participants at risk
EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
|
TachoSil
n=81 participants at risk
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.0%
18/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
25.9%
21/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.3%
7/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
8.6%
7/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Atrial fibrillation
|
45.3%
34/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
35.8%
29/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Cardiac failure congestive
|
5.3%
4/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
9.9%
8/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Cardiac disorders
Tachycardia
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Gastrointestinal disorders
Constipation
|
20.0%
15/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
18.5%
15/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
10.7%
8/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
2.5%
2/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Gastrointestinal disorders
Nausea
|
25.3%
19/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
24.7%
20/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
5/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
9.3%
7/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
General disorders
Chest pain
|
6.7%
5/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
3.7%
3/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
General disorders
Oedema peripheral
|
6.7%
5/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
16.0%
13/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
General disorders
Pain
|
12.0%
9/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
13.6%
11/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
General disorders
Pyrexia
|
14.7%
11/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
12.3%
10/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Pneumonia
|
6.7%
5/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
4.9%
4/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Urinary tract infection
|
12.0%
9/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Infections and infestations
Wound infection
|
5.3%
4/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
4.9%
4/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
5.3%
4/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
0.00%
0/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
6.7%
5/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.0%
9/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
11.1%
9/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Fluid overload
|
16.0%
12/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
13.6%
11/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.7%
11/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
13.6%
11/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
6/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
2.5%
2/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.0%
6/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
4.9%
4/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.3%
7/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
8.6%
7/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
5/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
1.2%
1/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.0%
6/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
3.7%
3/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Nervous system disorders
Dizziness
|
6.7%
5/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
3.7%
3/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Psychiatric disorders
Anxiety
|
2.7%
2/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Psychiatric disorders
Confusional state
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
7.4%
6/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Psychiatric disorders
Delirium
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
8.6%
7/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Renal and urinary disorders
Renal failure acute
|
4.0%
3/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
11.1%
9/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.0%
6/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
14.8%
12/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
4/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
7.4%
6/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.3%
7/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
32.0%
24/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
27.2%
22/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.7%
8/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
6.2%
5/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
6.7%
5/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
4.9%
4/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Vascular disorders
Hypertension
|
5.3%
4/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
11.1%
9/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
|
Vascular disorders
Hypotension
|
20.0%
15/75 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
22.2%
18/81 • From surgical procedure through the 60 day follow-up (+/-14 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60