Hemorrhage, Peripheral Vascular Disease
Conditions
Keywords
hemostasis
Brief summary
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
Interventions
BIOLOGICALEVICEL ™ Fibrin Sealant (Human)
Commercial Evicel
Sponsors
OMRIX Biopharmaceuticals
Ethicon, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery * EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es * Subjects must be willing to and capable of participating in the study, and provide written informed consent
Exclusion criteria
* Subjects with known intolerance to blood products * Subjects unwilling to receive blood products * Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding * Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specific Safety Parameters | Up to 4-weeks post-operatively | * Incidence of graft occlusion * Incidence of adverse events potentially related to non-graft thrombotic events * Incidence of bleeding events |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 300 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | EVICEL® Fibrin Sealant (Human) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 149 Participants |
| Age, Categorical Between 18 and 65 years | 151 Participants |
| Age, Continuous | 64 years |
| BMI (grouped) Morbidly obese | 24 participants |
| BMI (grouped) Normal | 84 participants |
| BMI (grouped) Obese | 108 participants |
| BMI (grouped) Overweight | 79 participants |
| BMI (grouped) Underweight | 5 participants |
| History of Smoking Current smoker | 56 participants |
| History of Smoking Ex-smoker | 136 participants |
| History of Smoking Never smoked | 108 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 105 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 185 Participants |
| Region of Enrollment United States | 300 participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 180 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 300 |
| serious Total, serious adverse events | 22 / 300 |
Outcome results
Primary
Specific Safety Parameters
* 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
Population: From participant flow, 283 subjects completed the study; One subject lost to follow-up had 4-week information in hospital records.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVICEL® Fibrin Sealant (Human) | Specific Safety Parameters | Graft Occlusion | 12 participants |
| EVICEL® Fibrin Sealant (Human) | Specific Safety Parameters | AE potentially related to non-graft thrombosis | 7 participants |
| EVICEL® Fibrin Sealant (Human) | Specific Safety Parameters | Bleeding events | 0 participants |