Trial Outcomes & Findings for The Evicel Post-Authorization Surveillance Study (NCT NCT01158261)
NCT ID: NCT01158261
Last Updated: 2015-08-19
Results Overview
* Incidence of graft occlusion * Incidence of adverse events potentially related to non-graft thrombotic events * Incidence of bleeding events
Recruitment status
COMPLETED
Target enrollment
300 participants
Primary outcome timeframe
Up to 4-weeks post-operatively
Results posted on
2015-08-19
Participant Flow
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.
Participant milestones
| Measure |
EVICEL® Fibrin Sealant (Human)
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 Study
STARTED
|
300
|
|
Overall Study
COMPLETED
|
283
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
EVICEL® Fibrin Sealant (Human)
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 Study
Lost to Follow-up
|
9
|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
The Evicel Post-Authorization Surveillance Study
Baseline characteristics by cohort
| Measure |
EVICEL® Fibrin Sealant (Human)
n=300 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
151 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
149 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
185 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
300 participants
n=5 Participants
|
|
BMI (grouped)
Underweight
|
5 participants
n=5 Participants
|
|
BMI (grouped)
Normal
|
84 participants
n=5 Participants
|
|
BMI (grouped)
Overweight
|
79 participants
n=5 Participants
|
|
BMI (grouped)
Obese
|
108 participants
n=5 Participants
|
|
BMI (grouped)
Morbidly obese
|
24 participants
n=5 Participants
|
|
History of Smoking
Never smoked
|
108 participants
n=5 Participants
|
|
History of Smoking
Ex-smoker
|
136 participants
n=5 Participants
|
|
History of Smoking
Current smoker
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4-weeks post-operativelyPopulation: From participant flow, 283 subjects completed the study; One subject lost to follow-up had 4-week information in hospital records.
* Incidence of graft occlusion * Incidence of adverse events potentially related to non-graft thrombotic events * Incidence of bleeding events
Outcome measures
| Measure |
EVICEL® Fibrin Sealant (Human)
n=284 Participants
|
|---|---|
|
Specific Safety Parameters
Graft Occlusion
|
12 participants
|
|
Specific Safety Parameters
AE potentially related to non-graft thrombosis
|
7 participants
|
|
Specific Safety Parameters
Bleeding events
|
0 participants
|
Adverse Events
EVICEL® Fibrin Sealant (Human)
Serious events: 22 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVICEL® Fibrin Sealant (Human)
n=300 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Cardiac disorders
Bradycardia
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Cardiac disorders
Cardiac arrest
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Cardiac disorders
Cardiogenic shock
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Infections and infestations
Groin abscess
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Infections and infestations
Sepsis
|
0.67%
2/300 • From enrollment through the 4-week follow-up
|
|
Infections and infestations
Septic shock
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Infections and infestations
Staphylococcal infection
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Injury, poisoning and procedural complications
Ateriovenous fistula site complication
|
0.67%
2/300 • From enrollment through the 4-week follow-up
|
|
Injury, poisoning and procedural complications
Eschar
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.67%
2/300 • From enrollment through the 4-week follow-up
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Nervous system disorders
Paraplegia
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Renal and urinary disorders
Renal failure acute
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Vascular disorders
Hypotension
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Vascular disorders
Peripheral vascular disorder
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Vascular disorders
Steal syndrome
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Vascular disorders
Thrombosis
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Vascular disorders
Venous thrombosis limb
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
Other adverse events
| Measure |
EVICEL® Fibrin Sealant (Human)
n=300 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
1.3%
4/300 • From enrollment through the 4-week follow-up
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
1.0%
3/300 • From enrollment through the 4-week follow-up
|
|
Vascular disorders
Hypotension
|
0.67%
2/300 • From enrollment through the 4-week follow-up
|
|
Vascular disorders
Steal Syndrome
|
0.67%
2/300 • From enrollment through the 4-week follow-up
|
|
Cardiac disorders
Nodal rhythm
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Infections and infestations
Graft infection
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Investigations
Urine analysis abnormal
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Renal and urinary disorders
Haematuria
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Renal and urinary disorders
Urethral stenosis
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.33%
1/300 • From enrollment through the 4-week follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place