The EVICEL® Gastrointestinal Study | NCT01589822

Label	Type	Description	Intervention Names
EVICEL Fibrin Sealant: Randomized	Experimental	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.	Biological: EVICEL Fibrin Sealant
Standard of Care	No Intervention	Standard surgical technique for GI anastomosis.
Experimental: EVICEL Fibrin Sealant: Non-Randomized	Experimental	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen	Biological: EVICEL Fibrin Sealant

Name	Type	Description	Arm Group Labels	Other Names
EVICEL Fibrin Sealant	Biological	Intraoperative	EVICEL Fibrin Sealant: Randomized Experimental: EVICEL Fibrin Sealant: Non-Randomized

Measure	Description	Time Frame
Absence of Gastrointestinal (GI) Leak		40 days

Measure	Description	Time Frame
Incidence of Adverse Events		up to Day 90
Incidence of GI Leak		90 days
Incidence of Stricture

Name	Affiliation	Role
Richard Kocharian, MD	Ethicon, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Investigation Site #1		Irvine	California	92868	United States
Clinical Investigation Site #2

ID	Title	Description
FG000	EVICEL Fibrin Sealant: Randomized	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative
FG001	Standard of Care

ID	Title	Description
BG000	EVICEL Fibrin Sealant: Randomized	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative
BG001	Standard of Care	Standard surgical technique for GI anastomosis.
BG002	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
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00084 BG00189 BG00241 BG003214

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Absence of Gastrointestinal (GI) Leak

Posted

Number

participants

40 days

ID	Title	Description
OG000	EVICEL Fibrin Sealant: Randomized	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (IIT)
OG001	Standard of Care	Standard surgical technique for GI anastomosis. (IIT)
OG002	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 (Safety Set)

Units	Counts
Participants	OG00084 OG00189 OG00241

Title

Denominators

Categories

Title	Measurements
	OG00072 OG00181 OG00238

Secondary

Incidence of Adverse Events

Posted

Number

number of adverse events

up to Day 90

ID	Title	Description
OG000	EVICEL Fibrin Sealant: Randomized	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (Safety Set)
OG001	Standard of Care	Standard surgical technique for GI anastomosis. (Safety Set)
OG002	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 (Safety Set)

Units	Counts
Participants	OG000

Secondary

Incidence of GI Leak

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.

Posted

Number

participants

90 days

ID	Title	Description
OG000	EVICEL Fibrin Sealant: Randomized	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (Safety Set)
OG001	Standard of Care	Standard surgical technique for GI anastomosis. (Safety Set)
OG002	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 (Safety Set)

Units	Counts

Secondary

Incidence of Stricture

Posted

Number

participants

up to Day 90

ID	Title	Description
OG000	EVICEL Fibrin Sealant: Randomized	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (Safety Set)
OG001	Standard of Care	Standard surgical technique for GI anastomosis. (Safety Set)
OG002	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 (Safety Set)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Statistical Information
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
ANGINA UNSTABLE	Cardiac disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	EG0000 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
CARDIAC ARREST	Cardiac disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
COLITIS	Gastrointestinal disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
CONSTIPATION	Gastrointestinal disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
DIARRHOEA	Gastrointestinal disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
ENTEROCUTANEOUS FISTULA	Gastrointestinal disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
ILEUS	Gastrointestinal disorders	EG0003 affected84 at risk EG0012 affected89 at risk EG0020 affected41 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	EG0001 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	EG0000 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	EG0000 affected84 at risk EG0012 affected89 at risk EG0020 affected41 at risk
SMALL INTESTINAL PERFORATION	Gastrointestinal disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0021 affected41 at risk
CHEST PAIN	General disorders	EG0000 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
PYREXIA	General disorders	EG0002 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
PORTAL VEIN THROMBOSIS	Hepatobiliary disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
ABDOMINAL INFECTION	Infections and infestations	EG0000 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
ABDOMINAL SEPSIS	Infections and infestations	EG0002 affected84 at risk EG0012 affected89 at risk EG0021 affected41 at risk
ABSCESS	Infections and infestations	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
CELLULITIS	Infections and infestations	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
ENDOCARDITIS	Infections and infestations	EG0000 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
GASTROENTERITIS	Infections and infestations	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
HAEMATOMA INFECTION	Infections and infestations	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
INFECTIOUS PERITONITIS	Infections and infestations	EG0002 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
LIVER ABSCESS	Infections and infestations	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
NECROTISING FASCIITIS	Infections and infestations	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
PELVIC ABSCESS	Infections and infestations	EG0002 affected84 at risk EG0012 affected89 at risk EG0020 affected41 at risk
PERITONITIS	Infections and infestations	EG0002 affected84 at risk EG0013 affected89 at risk EG0020 affected41 at risk
PYELONEPHRITIS	Infections and infestations	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	EG0000 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
URINARY TRACT INFECTION	Infections and infestations	EG0000 affected84 at risk EG0013 affected89 at risk EG0020 affected41 at risk
ANASTOMOTIC HAEMORRHAGE	Injury, poisoning and procedural complications	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
ANASTOMOTIC LEAK	Injury, poisoning and procedural complications	EG0009 affected84 at risk EG0016 affected89 at risk EG0023 affected41 at risk
ANASTOMOTIC STENOSIS	Injury, poisoning and procedural complications	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
INTESTINAL ANASTOMOSIS COMPLICATION	Injury, poisoning and procedural complications	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
POSTOPERATIVE ILEUS	Injury, poisoning and procedural complications	EG0000 affected84 at risk EG0013 affected89 at risk EG0020 affected41 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
WOUND EVISCERATION	Injury, poisoning and procedural complications	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
BLOOD MAGNESIUM DECREASED	Investigations	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
DEHYDRATION	Metabolism and nutrition disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
URETHRAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
CRITICAL ILLNESS POLYNEUROPATHY	Nervous system disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
CONFUSIONAL STATE	Psychiatric disorders	EG0000 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
DEPRESSION	Psychiatric disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	EG0001 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
URETERIC STENOSIS	Renal and urinary disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
URETHRAL STENOSIS	Renal and urinary disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
PELVIC HAEMATOMA	Respiratory, thoracic and mediastinal disorders	EG0000 affected84 at risk EG0010 affected89 at risk EG0021 affected41 at risk
BRONCHIAL SECRETION RETENTION	Respiratory, thoracic and mediastinal disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	EG0001 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	EG0001 affected84 at risk EG0010 affected89 at risk EG0020 affected41 at risk
ABSCESS DRAINAGE	Surgical and medical procedures	EG0000 affected84 at risk EG0011 affected89 at risk EG0020 affected41 at risk

Other Adverse Events

Term	Organ System	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	EG0003 affected84 at risk EG0015 affected89 at risk EG0024 affected41 at risk
TACHYCARDIA	Cardiac disorders	EG0006 affected84 at risk EG00112 affected89 at risk EG0024 affected41 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	EG00012 affected84 at risk EG00117 affected89 at risk EG0025 affected41 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	EG00017 affected84 at risk EG00117 affected89 at risk EG0028 affected41 at risk
CONSTIPATION	Gastrointestinal disorders	EG00014 affected84 at risk EG00117 affected89 at risk EG00211 affected41 at risk
DIARRHOEA	Gastrointestinal disorders	EG00011 affected84 at risk EG00115 affected89 at risk EG0028 affected41 at risk
ILEUS	Cardiac disorders	EG0006 affected84 at risk EG0015 affected89 at risk EG0021 affected41 at risk
NAUSEA	Gastrointestinal disorders	EG00042 affected84 at risk EG00147 affected89 at risk EG00222 affected41 at risk
PROCTALGIA	Gastrointestinal disorders	EG0003 affected84 at risk EG0015 affected89 at risk EG0021 affected41 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	EG0003 affected84 at risk EG0015 affected89 at risk EG0024 affected41 at risk
VOMITING	Gastrointestinal disorders	EG00020 affected84 at risk EG00122 affected89 at risk EG00211 affected41 at risk
FATIGUE	General disorders	EG0007 affected84 at risk EG0013 affected89 at risk EG0024 affected41 at risk
PAIN	General disorders	EG0005 affected84 at risk EG00110 affected89 at risk EG0025 affected41 at risk
PYREXIA	General disorders	EG00015 affected84 at risk EG00117 affected89 at risk EG0029 affected41 at risk
URINARY TRACT INFECTION	Infections and infestations	EG0005 affected84 at risk EG00111 affected89 at risk EG0021 affected41 at risk
WOUND INFECTION	Infections and infestations	EG0002 affected84 at risk EG0015 affected89 at risk EG0024 affected41 at risk
ANASTOMOTIC LEAK	Injury, poisoning and procedural complications	EG0009 affected84 at risk EG0016 affected89 at risk EG0023 affected41 at risk
INCISION SITE PAIN	Injury, poisoning and procedural complications	EG0003 affected84 at risk EG0013 affected89 at risk EG0026 affected41 at risk
PROCEDURAL PAINii	Injury, poisoning and procedural complications	EG00019 affected84 at risk EG00117 affected89 at risk EG0026 affected41 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	EG0005 affected84 at risk EG0012 affected89 at risk EG0020 affected41 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	EG0004 affected84 at risk EG0016 affected89 at risk EG0020 affected41 at risk
OXYGEN SATURATION DECREASED	Investigations	EG0006 affected84 at risk EG0011 affected89 at risk EG0021 affected41 at risk
URINE OUTPUT DECREASED	Investigations	EG0007 affected84 at risk EG00110 affected89 at risk EG0022 affected41 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	EG0005 affected84 at risk EG0012 affected89 at risk EG0021 affected41 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	EG0008 affected84 at risk EG0016 affected89 at risk EG0022 affected41 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	EG0005 affected84 at risk EG0019 affected89 at risk EG0025 affected41 at risk
DIZZINESS	Nervous system disorders	EG0005 affected84 at risk EG0019 affected89 at risk EG0024 affected41 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	EG0003 affected84 at risk EG0015 affected89 at risk EG0022 affected41 at risk
ANXIETY	Psychiatric disorders	EG0005 affected84 at risk EG0013 affected89 at risk EG0022 affected41 at risk
INSOMNIA	Psychiatric disorders	EG0007 affected84 at risk EG0017 affected89 at risk EG0026 affected41 at risk
DYSURIA	Renal and urinary disorders	EG0003 affected84 at risk EG0015 affected89 at risk EG0022 affected41 at risk
URINARY RETENTION	Renal and urinary disorders	EG0003 affected84 at risk EG0015 affected89 at risk EG0020 affected41 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	EG0005 affected84 at risk EG0013 affected89 at risk EG0021 affected41 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	EG0001 affected84 at risk EG0015 affected89 at risk EG0022 affected41 at risk
PRURITUS	Skin and subcutaneous tissue disorders	EG0009 affected84 at risk EG0018 affected89 at risk EG0026 affected41 at risk
HYPERTENSION	Vascular disorders	EG0004 affected84 at risk EG0019 affected89 at risk EG0023 affected41 at risk
HYPOTENSION	Vascular disorders	EG00013 affected84 at risk EG00116 affected89 at risk EG0025 affected41 at risk

ID	Term
D005337	Fibrin
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	EVICEL Fibrin Sealant: Randomized	EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen. EVICEL Fibrin Sealant: Intraoperative (Safety Set)	25	84	81	84
EG001	Standard of Care	Standard surgical technique for GI anastomosis. (Safety Set)	22	89	83	89
EG002	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 (Safety Set)	10	41	41	41