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Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

NCT ID: NCT00154141

Last Updated: 2006-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-03-31

Brief Summary

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A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.

Detailed Description

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Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Fibrin sealant (FS2)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side femoral or upper extremity vascular access arterial anastomosis (e.g. femoral-femoral, femoral-popliteal, femoral-tibial, ilio-femoral, aorto-bifemoral, abdominal aortic aneurysm, upper extremity vascular access for dialysis) using uncoated or heparin-coated PTFE grafts and polypropylene sutures (size 5-0 or 6-0) with a 1:1 needle-to-thread ratio.
* Following initial arterial clamp release, the study surgeon determines that adjunctive measures are needed to obtain haemostasis at the SAS.
* Subjects must be willing to and capable of participating in the study, and provided written informed consent.

Exclusion Criteria

* Subjects undergoing re-vascularisation using autologous conduits (e.g. saphenous vein) or prosthetic material other than uncoated or heparin-coated PTFE.
* Subjects undergoing emergency surgery.
* Subjects with any intra-operative findings that may preclude conduct of the study procedure.
* Subjects with known intolerance to heparin, blood products or to one of the components of the study product.
* Subjects unwilling to receive blood products.
* Subjects with autoimmune immunodeficiency diseases (including known HIV).
* Subjects who are known, current alcohol and / or drug abusers.
* Subjects who have participated in another investigational drug or device research study within 30 days of enrolment.
* Female subjects who are pregnant or nursing.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OMRIX Biopharmaceuticals

INDUSTRY

Sponsor Role collaborator

Ethicon, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Baptist Medical Center

Jacksonville, Florida, United States

Site Status

Memorial Hospital

Jacksonville, Florida, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Iowa Heart Center

Des Moines, Iowa, United States

Site Status

Univ of Mass Medical Center

Worcester, Massachusetts, United States

Site Status

Hackensack Medical Center

Hackensack, New Jersey, United States

Site Status

Alband Medical Center

Albany, New York, United States

Site Status

Millarad Fillmore Hospital, SUNY

Buffalo, New York, United States

Site Status

Jobst Vascular Center

Toledo, Ohio, United States

Site Status

Vanderbilt Univ Medical Center

Nashville, Tennessee, United States

Site Status

UVA Health System

Charlottesville, Virginia, United States

Site Status

Vascular and Transplant Specialists

Norfolk, Virginia, United States

Site Status

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Site Status

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status

Hull Royal Infirmary

Hull, , United Kingdom

Site Status

Countries

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United States United Kingdom

References

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Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

Reference Type DERIVED
PMID: 38695613 (View on PubMed)

Chalmers RT, Darling Iii RC, Wingard JT, Chetter I, Cutler B, Kern JA, Hart JC. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Br J Surg. 2010 Dec;97(12):1784-9. doi: 10.1002/bjs.7235. Epub 2010 Aug 20.

Reference Type DERIVED
PMID: 20730858 (View on PubMed)

Other Identifiers

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400-05-001

Identifier Type: -

Identifier Source: org_study_id