Trial Outcomes & Findings for Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery (NCT NCT01662856)
NCT ID: NCT01662856
Last Updated: 2017-04-06
Results Overview
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
225 participants
Primary outcome timeframe
From start of treatment until 4 minutes after treatment start
Results posted on
2017-04-06
Participant Flow
Participant milestones
| Measure |
Fibrin Sealant Grifols
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
|
Manual Compression
Direct manual compression of target bleeding site with gauze/laparotomy pads.
|
|---|---|---|
|
Part I + Part II (Overall Study)
STARTED
|
168
|
57
|
|
Part I + Part II (Overall Study)
Completed Study up to Week 6
|
164
|
56
|
|
Part I + Part II (Overall Study)
COMPLETED
|
152
|
55
|
|
Part I + Part II (Overall Study)
NOT COMPLETED
|
16
|
2
|
|
Primary Part II
STARTED
|
109
|
57
|
|
Primary Part II
Completed Study up to Week 6
|
106
|
56
|
|
Primary Part II
COMPLETED
|
99
|
55
|
|
Primary Part II
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
Baseline characteristics by cohort
| Measure |
Fibrin Sealant Grifols
n=168 Participants
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
|
Manual Compression
n=57 Participants
Direct manual compression of target bleeding site with gauze/laparotomy pads.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.65 years
STANDARD_DEVIATION 9.036 • n=99 Participants
|
62.04 years
STANDARD_DEVIATION 10.734 • n=107 Participants
|
63.24 years
STANDARD_DEVIATION 9.496 • n=206 Participants
|
|
Age, Customized
Between 18 and 64 years
|
90 participants
n=99 Participants
|
32 participants
n=107 Participants
|
122 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
78 participants
n=99 Participants
|
25 participants
n=107 Participants
|
103 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
18 participants
n=99 Participants
|
3 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
49 participants
n=99 Participants
|
23 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=99 Participants
|
16 participants
n=107 Participants
|
85 participants
n=206 Participants
|
|
Region of Enrollment
Serbia
|
32 participants
n=99 Participants
|
15 participants
n=107 Participants
|
47 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From start of treatment until 4 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=109 Participants
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
|
Manual Compression
n=57 Participants
Direct manual compression of target bleeding site with gauze/laparotomy pads.
|
|---|---|---|
|
Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start
|
76.1 Percent of subjects achieving hemostasis
|
22.8 Percent of subjects achieving hemostasis
|
SECONDARY outcome
Timeframe: From start of treatment until 10 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start. In the Fibrin Sealant Grifols treatment group, the median TTH was calculated based on the estimated survival function S(t), and it is the smallest time at which S(t) is at or below 50%. The 95% CI for the median TTH, on the other hand, was calculated based on the CI for the survival function S(t). The 95% CI for the median TTH was the set of all time points for which the 95% CI of the survival function contains 0.5 (since median is the 50% percentile). Sometimes, the confidence limits for the median cannot be estimated. In our case, the hemostasis was assessed on a discrete scale, and it happened that for all the time points assessed none of the 95% CI of the survival function S(t) contained 0.5. As a result, neither the lower nor the upper limit could be estimated. All calculations were performed using SAS PROC LIFETEST
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=109 Participants
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
|
Manual Compression
n=57 Participants
Direct manual compression of target bleeding site with gauze/laparotomy pads.
|
|---|---|---|
|
Time to Hemostasis (TTH)
|
4.0 minutes
Neither the lower nor upper 95% CI limit for median TTH could be estimated; for all time points with hemostatic assessment, none of the 95% CIs of the S(t) contained 0.5 (corresponding to the 50th percentile, ie, median). See Measure Description.
|
NA minutes
Interval 10.0 to
Median TTH could not be estimated precisely; most subjects did not achieve hemostasis by 10 minutes after start of treatment and were considered censored. Lower limit of the 95% CI was 10 minutes, it was deduced that the median TTH was ≥10 minutes.
|
SECONDARY outcome
Timeframe: From start of treatment until 10 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Cumulative proportion of subjects having achieved hemostasis by each of the following time points: * At 5 minutes following start of study treatment * At 7 minutes following start of study treatment * At 10 minutes following start of study treatment
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=109 Participants
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
|
Manual Compression
n=57 Participants
Direct manual compression of target bleeding site with gauze/laparotomy pads.
|
|---|---|---|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 5 minutes
|
80.7 Percent of subjects achieving hemostasis
|
28.1 Percent of subjects achieving hemostasis
|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 7 minutes
|
84.4 Percent of subjects achieving hemostasis
|
35.1 Percent of subjects achieving hemostasis
|
|
Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points
Hemostasis by 10 minutes
|
88.1 Percent of subjects achieving hemostasis
|
45.6 Percent of subjects achieving hemostasis
|
SECONDARY outcome
Timeframe: From start of treatment until 10 minutes after treatment startPopulation: Efficacy analysis was performed on subjects in the Primary Part (II) of the study
Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.
Outcome measures
| Measure |
Fibrin Sealant Grifols
n=109 Participants
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
|
Manual Compression
n=57 Participants
Direct manual compression of target bleeding site with gauze/laparotomy pads.
|
|---|---|---|
|
Prevalence of Treatment Failures
|
23.9 percent of subjects
|
77.2 percent of subjects
|
Adverse Events
Fibrin Sealant Grifols
Serious events: 34 serious events
Other events: 132 other events
Deaths: 0 deaths
Manual Compression
Serious events: 11 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fibrin Sealant Grifols
n=168 participants at risk
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
|
Manual Compression
n=57 participants at risk
Direct manual compression of target bleeding site with gauze/laparotomy pads.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Atrial flutter
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Asthenia
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Death
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Multi-organ failure
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Pyrexia
|
0.00%
0/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Immune system disorders
Anaphylactic reaction
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Cellulitis
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Endocarditis
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Gangrene
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
3.5%
2/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Graft infection
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Pneumonia
|
1.8%
3/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Postoperative wound infection
|
1.8%
3/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Sepsis
|
0.00%
0/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Infections and infestations
Wound infection
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Reocclusion
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
3.5%
2/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Investigations
Parvovirus B19 test positive
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Encephalopathy
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Syncope
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Nervous system disorders
Transient ischaemic attack
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Psychiatric disorders
Mental status changes
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Renal and urinary disorders
Renal failure acute
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Deep vein thrombosis
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Hypertensive crisis
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Lymphorrhoea
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.60%
1/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Peripheral ischaemia
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
0.00%
0/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
Other adverse events
| Measure |
Fibrin Sealant Grifols
n=168 participants at risk
Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
|
Manual Compression
n=57 participants at risk
Direct manual compression of target bleeding site with gauze/laparotomy pads.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
10/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
3.5%
2/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Constipation
|
4.2%
7/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
7.0%
4/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Nausea
|
6.0%
10/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
3.5%
2/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
4/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
5.3%
3/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Oedema peripheral
|
7.7%
13/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
1.8%
1/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
General disorders
Pyrexia
|
11.3%
19/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
10.5%
6/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
5.4%
9/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
3.5%
2/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Injury, poisoning and procedural complications
Procedural pain
|
34.5%
58/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
36.8%
21/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Investigations
Body temperature increased
|
6.0%
10/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
7.0%
4/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
|
Vascular disorders
Hypotension
|
1.2%
2/168 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
5.3%
3/57 • Adverse event data were collected from the time informed consent was obtained through the Post-Operative Week 6 (±4 days) Visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER