The Evicel Post-Authorization Surveillance Study

NCT01158261 | Completed Results

• 1 other identifier: 400-08-004
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Vascular Disease; Hemorrhage

Keywords

hemostasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Vascular Surgery Subjects Treated with EVICEL

Biological: EVICEL ™ Fibrin Sealant (Human)

Interventions

EVICEL ™ Fibrin Sealant (Human) BIOLOGICAL

Commercial Evicel

Also known as: Fibrin Sealant (Human)

Vascular Surgery Subjects Treated with EVICEL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects requiring elective vascular procedures

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead
• OMRIX Biopharmaceuticals: collaborator

Study Sites (2)

Baptist Health Medical Center

Jacksonville, Florida, 32207, United States

Location

Memorial Hospital

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Hemorrhage

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Limitations of the study include the small number of centers involved and the observational nature of the design.

Results Point of Contact

• Title: Director of Clinical Development
• Organization: Ethicon, Inc

jbatill2@its.jnj.com

908-218-2492

Study Officials

• Richard Kocharian, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 8, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 19, 2015
• Results First Posted: August 19, 2015

Record last verified: 2015-07

Locations

US (2)