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

This study has been completed.
Information provided by:
Baxter Healthcare Corporation Identifier:
First received: September 8, 2005
Last updated: October 20, 2006
Last verified: October 2006
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 Intervention Phase
Femoral Vascular Anastomosis Drug: Tissucol® Procedure: Control: Conventional treatment, i.e. compression with swabs Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 60
Study Start Date: September 2003
Estimated Study Completion Date: February 2004

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
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Please refer to this study by its identifier: 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 Identifier: NCT00163592     History of Changes
Other Study ID Numbers: 530301
Study First Received: September 8, 2005
Last Updated: October 20, 2006

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

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Coagulants processed this record on July 19, 2017