The Evicel Post-Authorization Surveillance Study

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158261
• Other study ID #: 400-08-004
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: July 22, 2015
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Biological:
• EVICEL ™ Fibrin Sealant (Human)
Commercial Evicel

Locations

Country	Name	City	State
United States	Baptist Health Medical Center	Jacksonville	Florida
United States	Memorial Hospital	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Ethicon, Inc.	OMRIX Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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