Hemorrhage Clinical Trial
Official title:
A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery
Verified date | July 2015 |
Source | Ethicon, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | May 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Baptist Health Medical Center | Jacksonville | Florida |
United States | Memorial Hospital | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Ethicon, Inc. | OMRIX Biopharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specific Safety Parameters | Incidence of graft occlusion Incidence of adverse events potentially related to non-graft thrombotic events Incidence of bleeding events |
Up to 4-weeks post-operatively | Yes |
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