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The Evicel Post-Authorization Surveillance Study

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ClinicalTrials.gov Identifier: NCT01158261
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Collaborator:
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Peripheral Vascular Disease
Hemorrhage
Intervention Biological: EVICEL ™ Fibrin Sealant (Human)
Enrollment 300
Recruitment Details The first subject was enrolled 04 June 2010 and the last subject was enrolled 15 April 2014. The last data point collected for the trial was 21 May 2014.
Pre-assignment Details  
Arm/Group Title EVICEL® Fibrin Sealant (Human)
Hide Arm/Group Description All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
Period Title: Overall Study
Started 300
Completed 283
Not Completed 17
Reason Not Completed
Lost to Follow-up             9
Death             7
Withdrawal by Subject             1
Arm/Group Title EVICEL® Fibrin Sealant (Human)
Hide Arm/Group Description All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
Overall Number of Baseline Participants 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
<=18 years
0
   0.0%
Between 18 and 65 years
151
  50.3%
>=65 years
149
  49.7%
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 300 participants
64
(19 to 91)
[1]
Measure Description: The study population has a mean age of 62.2 years (std 13.9). The median is reported in the table below.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
Female
120
  40.0%
Male
180
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   1.3%
Native Hawaiian or Other Pacific Islander
2
   0.7%
Black or African American
105
  35.0%
White
185
  61.7%
More than one race
4
   1.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 300 participants
300
BMI (grouped)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 300 participants
Underweight 5
Normal 84
Overweight 79
Obese 108
Morbidly obese 24
History of Smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 300 participants
Never smoked 108
Ex-smoker 136
Current smoker 56
1.Primary Outcome
Title Specific Safety Parameters
Hide Description
  • Incidence of graft occlusion
  • Incidence of adverse events potentially related to non-graft thrombotic events
  • Incidence of bleeding events
Time Frame Up to 4-weeks post-operatively
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
From participant flow, 283 subjects completed the study; One subject lost to follow-up had 4-week information in hospital records.
Arm/Group Title EVICEL® Fibrin Sealant (Human)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 284
Measure Type: Number
Unit of Measure: participants
Graft Occlusion 12
AE potentially related to non-graft thrombosis 7
Bleeding events 0
Time Frame From enrollment through the 4-week follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EVICEL® Fibrin Sealant (Human)
Hide Arm/Group Description

An adverse event (AE) was defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of the EVICEL® product. For the purpose of this protocol, an AE was any untoward medical occurrence in a study subject that may be related or possibly related to the EVICEL® product. The relatedness to EVICEL® was based on the investigator’s assessment.

In the original version of the protocol, the SAE definition did not require that the AE be related or possibly related to the treatment. This discrepancy with the AE definition resulted in the sites reporting non-EVICEL® related AEs and SAEs prior to the amended protocol implementation.

All-Cause Mortality
EVICEL® Fibrin Sealant (Human)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EVICEL® Fibrin Sealant (Human)
Affected / at Risk (%)
Total   22/300 (7.33%) 
Cardiac disorders   
Angina pectoris  1/300 (0.33%) 
Bradycardia  1/300 (0.33%) 
Cardiac arrest  1/300 (0.33%) 
Cardio-respiratory arrest  1/300 (0.33%) 
Cardiogenic shock  1/300 (0.33%) 
Gastrointestinal disorders   
Diarrhoea  1/300 (0.33%) 
Infections and infestations   
Groin abscess  1/300 (0.33%) 
Sepsis  2/300 (0.67%) 
Septic shock  1/300 (0.33%) 
Staphylococcal infection  1/300 (0.33%) 
Injury, poisoning and procedural complications   
Ateriovenous fistula site complication  2/300 (0.67%) 
Eschar  1/300 (0.33%) 
Graft thrombosis  1/300 (0.33%) 
Vascular graft occlusion  2/300 (0.67%) 
Vascular graft thrombosis  1/300 (0.33%) 
Metabolism and nutrition disorders   
Dehydration  1/300 (0.33%) 
Nervous system disorders   
Cerebrovascular accident  1/300 (0.33%) 
Paraplegia  1/300 (0.33%) 
Renal and urinary disorders   
Renal failure acute  1/300 (0.33%) 
Vascular disorders   
Hypotension  1/300 (0.33%) 
Peripheral vascular disorder  1/300 (0.33%) 
Steal syndrome  1/300 (0.33%) 
Thrombosis  1/300 (0.33%) 
Venous thrombosis limb  1/300 (0.33%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EVICEL® Fibrin Sealant (Human)
Affected / at Risk (%)
Total   23/300 (7.67%) 
Cardiac disorders   
Nodal rhythm  1/300 (0.33%) 
Gastrointestinal disorders   
Nausea  1/300 (0.33%) 
Infections and infestations   
Graft infection  1/300 (0.33%) 
Injury, poisoning and procedural complications   
Arteriovenous fistula site complication  4/300 (1.33%) 
Vascular graft occlusion  3/300 (1.00%) 
Arteriovenous fistula thrombosis  1/300 (0.33%) 
Investigations   
Urine analysis abnormal  1/300 (0.33%) 
Metabolism and nutrition disorders   
Fluid overload  1/300 (0.33%) 
Hypokalaemia  1/300 (0.33%) 
Renal and urinary disorders   
Haematuria  1/300 (0.33%) 
Urethral stenosis  1/300 (0.33%) 
Skin and subcutaneous tissue disorders   
Erythema  1/300 (0.33%) 
Vascular disorders   
Hypotension  2/300 (0.67%) 
Steal Syndrome  2/300 (0.67%) 
Limitations of the study include the small number of centers involved and the observational nature of the design.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Development
Organization: Ethicon, Inc
Phone: 908-218-2492
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01158261     History of Changes
Other Study ID Numbers: 400-08-004
First Submitted: July 6, 2010
First Posted: July 8, 2010
Results First Submitted: July 22, 2015
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015