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Buffalo, New York 14209

  • Peripheral Vascular Disease

Purpose:

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


Criteria:

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.


Study is Available At:


Original ID:

400-05-001


NCT ID:

NCT00154141


Secondary ID:


Study Acronym:


Brief Title:

Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures


Official Title:

A Prospective, Randomized Controlled Study to Compare the Effects of a Fibrin Sealant (FS2) Versus Manual Compression on Haemostatic Efficacy During Vascular Surgical Procedures Utilising Polytetrafluorethylene Graft Material on an End-to-Side Femoral or


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ethicon, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:


Study Dates

Start Date:June 2005
Completion Date:March 2006
Verification Date:July 2006
Last Changed Date:July 11, 2006
First Received Date:September 7, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Attainment of hemostasis at following randomization.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Attainment of hemostasis following randomization.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of treatment failures
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of potential bleeding-related complications
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Adverse events
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Fibrin sealant (FS2)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Ethicon, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:OMRIX Biopharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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