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Post-Marketing Surveillance of TISSUCOL for Hemostasis in Subjects Undergoing Vascular Reconstruction With Polytetrafluoroethylene (PTFE) Prosthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00163592
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 23, 2006
Information provided by:

Study Description
Brief Summary:
This study investigates if the time to hemostasis can be reduced by application of Tissucol® onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as compression with swabs.

Condition or disease Intervention/treatment Phase
Femoral Vascular Anastomosis Drug: Tissucol® Procedure: Control: Conventional treatment, i.e. compression with swabs Phase 4

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Non- Interventional Study of Tissucol® for Hemostasis in Subjects With Femoral Vascular Anastomosis Undergoing Vascular Reconstruction With PTFE Prosthesis
Study Start Date : September 2003
Estimated Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Subjects with femoral vascular anastomosis and bleeding suture holes after vessel reconstruction with a PTFE prosthesis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163592

Landeskrankenhaus Innsbruck
Innsbruck, Tirol, Austria, 6020
General Hospital (AKH) Salzburg
Salzburg, Austria, 5020
Leonberg Hospital, Department of Vascular Surgery
Leonberg, Germany, 71229
University Clinics of Magdeburg, Department of Vascular Surgery
Magdeburg, Germany, 39120
Klinikum Nürnberg Süd, Department of Vascular Surgery
Nürnberg, Germany, 90340
Sponsors and Collaborators
Baxter Healthcare Corporation
Principal Investigator: Thomas Bürger, MD University Clinics of Magdeburg, Germany
More Information

ClinicalTrials.gov Identifier: NCT00163592     History of Changes
Other Study ID Numbers: 530301
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: October 2006

Keywords provided by Baxter Healthcare Corporation:
Vascular reconstruction
Polytetraflouroethylene (PTFE) prosthesis

Additional relevant MeSH terms:
Fibrin Tissue Adhesive