Trial Outcomes & Findings for The EVICEL® Gastrointestinal Study (NCT NCT01589822)
NCT ID: NCT01589822
Last Updated: 2015-02-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
214 participants
Primary outcome timeframe
40 days
Results posted on
2015-02-25
Participant Flow
Participant milestones
| Measure |
EVICEL Fibrin Sealant: Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative
|
Standard of Care
Standard surgical technique for GI anastomosis.
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
89
|
41
|
|
Overall Study
COMPLETED
|
80
|
86
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
1
|
Reasons for withdrawal
| Measure |
EVICEL Fibrin Sealant: Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative
|
Standard of Care
Standard surgical technique for GI anastomosis.
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Missed 90 day visit
|
2
|
1
|
1
|
Baseline Characteristics
The EVICEL® Gastrointestinal Study
Baseline characteristics by cohort
| Measure |
EVICEL Fibrin Sealant: Randomized
n=84 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative
|
Standard of Care
n=89 Participants
Standard surgical technique for GI anastomosis.
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
n=41 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
13 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
3 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
6 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
1 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
7 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
7 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 40 daysOutcome measures
| Measure |
EVICEL Fibrin Sealant: Randomized
n=84 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (IIT)
|
Standard of Care
n=89 Participants
Standard surgical technique for GI anastomosis. (IIT)
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
n=41 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)
|
|---|---|---|---|
|
Absence of Gastrointestinal (GI) Leak
|
72 participants
|
81 participants
|
38 participants
|
SECONDARY outcome
Timeframe: up to Day 90Outcome measures
| Measure |
EVICEL Fibrin Sealant: Randomized
n=84 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (IIT)
|
Standard of Care
n=89 Participants
Standard surgical technique for GI anastomosis. (IIT)
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
n=41 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)
|
|---|---|---|---|
|
Incidence of Adverse Events
|
633 number of adverse events
|
735 number of adverse events
|
347 number of adverse events
|
SECONDARY outcome
Timeframe: 90 daysPopulation: The primary endpoint was absence of leak (success) within 40 days. Any data missing was considered failures. 3 EVICEL and 2 SoC subjects had missing data. These subjects were considered failures for the primary endpoint. The secondary endpoint was incidence of leak within 90 days post operatively. Missing data was not assumed to be leaks.
Outcome measures
| Measure |
EVICEL Fibrin Sealant: Randomized
n=84 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (IIT)
|
Standard of Care
n=89 Participants
Standard surgical technique for GI anastomosis. (IIT)
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
n=41 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)
|
|---|---|---|---|
|
Incidence of GI Leak
|
9 participants
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: up to Day 90Outcome measures
| Measure |
EVICEL Fibrin Sealant: Randomized
n=84 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (IIT)
|
Standard of Care
n=89 Participants
Standard surgical technique for GI anastomosis. (IIT)
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
n=41 Participants
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)
|
|---|---|---|---|
|
Incidence of Stricture
|
2 participants
|
3 participants
|
1 participants
|
Adverse Events
EVICEL Fibrin Sealant: Randomized
Serious events: 25 serious events
Other events: 81 other events
Deaths: 0 deaths
Standard of Care
Serious events: 22 serious events
Other events: 83 other events
Deaths: 0 deaths
Experimental: EVICEL Fibrin Sealant: Non-Randomized
Serious events: 10 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVICEL Fibrin Sealant: Randomized
n=84 participants at risk
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (Safety Set)
|
Standard of Care
n=89 participants at risk
Standard surgical technique for GI anastomosis. (Safety Set)
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
n=41 participants at risk
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)
|
|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Cardiac disorders
ANGINA UNSTABLE
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Cardiac disorders
CARDIAC ARREST
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
ILEUS
|
3.6%
3/84 • AEs occurring up to study Day-90
|
2.2%
2/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
1.2%
1/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
2.2%
2/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
General disorders
CHEST PAIN
|
0.00%
0/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
General disorders
PYREXIA
|
2.4%
2/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
ABDOMINAL SEPSIS
|
2.4%
2/84 • AEs occurring up to study Day-90
|
2.2%
2/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
ABSCESS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
ENDOCARDITIS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
GASTROENTERITIS
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
HAEMATOMA INFECTION
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
INFECTIOUS PERITONITIS
|
2.4%
2/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
LIVER ABSCESS
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
PELVIC ABSCESS
|
2.4%
2/84 • AEs occurring up to study Day-90
|
2.2%
2/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
PERITONITIS
|
2.4%
2/84 • AEs occurring up to study Day-90
|
3.4%
3/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
3.4%
3/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC HAEMORRHAGE
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC LEAK
|
10.7%
9/84 • AEs occurring up to study Day-90
|
6.7%
6/89 • AEs occurring up to study Day-90
|
7.3%
3/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC STENOSIS
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
INTESTINAL ANASTOMOSIS COMPLICATION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ILEUS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
3.4%
3/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
WOUND EVISCERATION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Investigations
BLOOD MAGNESIUM DECREASED
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
URETHRAL CANCER
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Nervous system disorders
CRITICAL ILLNESS POLYNEUROPATHY
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Psychiatric disorders
DEPRESSION
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.2%
1/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Renal and urinary disorders
URETERIC STENOSIS
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Respiratory, thoracic and mediastinal disorders
PELVIC HAEMATOMA
|
0.00%
0/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL SECRETION RETENTION
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.2%
1/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
1.2%
1/84 • AEs occurring up to study Day-90
|
0.00%
0/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Surgical and medical procedures
ABSCESS DRAINAGE
|
0.00%
0/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
Other adverse events
| Measure |
EVICEL Fibrin Sealant: Randomized
n=84 participants at risk
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative (Safety Set)
|
Standard of Care
n=89 participants at risk
Standard surgical technique for GI anastomosis. (Safety Set)
|
Experimental: EVICEL Fibrin Sealant: Non-Randomized
n=41 participants at risk
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative (Safety Set)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.6%
3/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
9.8%
4/41 • AEs occurring up to study Day-90
|
|
Cardiac disorders
TACHYCARDIA
|
7.1%
6/84 • AEs occurring up to study Day-90
|
13.5%
12/89 • AEs occurring up to study Day-90
|
9.8%
4/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
14.3%
12/84 • AEs occurring up to study Day-90
|
19.1%
17/89 • AEs occurring up to study Day-90
|
12.2%
5/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
20.2%
17/84 • AEs occurring up to study Day-90
|
19.1%
17/89 • AEs occurring up to study Day-90
|
19.5%
8/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.7%
14/84 • AEs occurring up to study Day-90
|
19.1%
17/89 • AEs occurring up to study Day-90
|
26.8%
11/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
DIARRHOEA
|
13.1%
11/84 • AEs occurring up to study Day-90
|
16.9%
15/89 • AEs occurring up to study Day-90
|
19.5%
8/41 • AEs occurring up to study Day-90
|
|
Cardiac disorders
ILEUS
|
7.1%
6/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
42/84 • AEs occurring up to study Day-90
|
52.8%
47/89 • AEs occurring up to study Day-90
|
53.7%
22/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
PROCTALGIA
|
3.6%
3/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
3.6%
3/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
9.8%
4/41 • AEs occurring up to study Day-90
|
|
Gastrointestinal disorders
VOMITING
|
23.8%
20/84 • AEs occurring up to study Day-90
|
24.7%
22/89 • AEs occurring up to study Day-90
|
26.8%
11/41 • AEs occurring up to study Day-90
|
|
General disorders
FATIGUE
|
8.3%
7/84 • AEs occurring up to study Day-90
|
3.4%
3/89 • AEs occurring up to study Day-90
|
9.8%
4/41 • AEs occurring up to study Day-90
|
|
General disorders
PAIN
|
6.0%
5/84 • AEs occurring up to study Day-90
|
11.2%
10/89 • AEs occurring up to study Day-90
|
12.2%
5/41 • AEs occurring up to study Day-90
|
|
General disorders
PYREXIA
|
17.9%
15/84 • AEs occurring up to study Day-90
|
19.1%
17/89 • AEs occurring up to study Day-90
|
22.0%
9/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.0%
5/84 • AEs occurring up to study Day-90
|
12.4%
11/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Infections and infestations
WOUND INFECTION
|
2.4%
2/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
9.8%
4/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
ANASTOMOTIC LEAK
|
10.7%
9/84 • AEs occurring up to study Day-90
|
6.7%
6/89 • AEs occurring up to study Day-90
|
7.3%
3/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
INCISION SITE PAIN
|
3.6%
3/84 • AEs occurring up to study Day-90
|
3.4%
3/89 • AEs occurring up to study Day-90
|
14.6%
6/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAINii
|
22.6%
19/84 • AEs occurring up to study Day-90
|
19.1%
17/89 • AEs occurring up to study Day-90
|
14.6%
6/41 • AEs occurring up to study Day-90
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
6.0%
5/84 • AEs occurring up to study Day-90
|
2.2%
2/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
4.8%
4/84 • AEs occurring up to study Day-90
|
6.7%
6/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Investigations
OXYGEN SATURATION DECREASED
|
7.1%
6/84 • AEs occurring up to study Day-90
|
1.1%
1/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Investigations
URINE OUTPUT DECREASED
|
8.3%
7/84 • AEs occurring up to study Day-90
|
11.2%
10/89 • AEs occurring up to study Day-90
|
4.9%
2/41 • AEs occurring up to study Day-90
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
6.0%
5/84 • AEs occurring up to study Day-90
|
2.2%
2/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
9.5%
8/84 • AEs occurring up to study Day-90
|
6.7%
6/89 • AEs occurring up to study Day-90
|
4.9%
2/41 • AEs occurring up to study Day-90
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
6.0%
5/84 • AEs occurring up to study Day-90
|
10.1%
9/89 • AEs occurring up to study Day-90
|
12.2%
5/41 • AEs occurring up to study Day-90
|
|
Nervous system disorders
DIZZINESS
|
6.0%
5/84 • AEs occurring up to study Day-90
|
10.1%
9/89 • AEs occurring up to study Day-90
|
9.8%
4/41 • AEs occurring up to study Day-90
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
3.6%
3/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
4.9%
2/41 • AEs occurring up to study Day-90
|
|
Psychiatric disorders
ANXIETY
|
6.0%
5/84 • AEs occurring up to study Day-90
|
3.4%
3/89 • AEs occurring up to study Day-90
|
4.9%
2/41 • AEs occurring up to study Day-90
|
|
Psychiatric disorders
INSOMNIA
|
8.3%
7/84 • AEs occurring up to study Day-90
|
7.9%
7/89 • AEs occurring up to study Day-90
|
14.6%
6/41 • AEs occurring up to study Day-90
|
|
Renal and urinary disorders
DYSURIA
|
3.6%
3/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
4.9%
2/41 • AEs occurring up to study Day-90
|
|
Renal and urinary disorders
URINARY RETENTION
|
3.6%
3/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
0.00%
0/41 • AEs occurring up to study Day-90
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.0%
5/84 • AEs occurring up to study Day-90
|
3.4%
3/89 • AEs occurring up to study Day-90
|
2.4%
1/41 • AEs occurring up to study Day-90
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.2%
1/84 • AEs occurring up to study Day-90
|
5.6%
5/89 • AEs occurring up to study Day-90
|
4.9%
2/41 • AEs occurring up to study Day-90
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.7%
9/84 • AEs occurring up to study Day-90
|
9.0%
8/89 • AEs occurring up to study Day-90
|
14.6%
6/41 • AEs occurring up to study Day-90
|
|
Vascular disorders
HYPERTENSION
|
4.8%
4/84 • AEs occurring up to study Day-90
|
10.1%
9/89 • AEs occurring up to study Day-90
|
7.3%
3/41 • AEs occurring up to study Day-90
|
|
Vascular disorders
HYPOTENSION
|
15.5%
13/84 • AEs occurring up to study Day-90
|
18.0%
16/89 • AEs occurring up to study Day-90
|
12.2%
5/41 • AEs occurring up to study Day-90
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60