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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.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00163592
First received: September 8, 2005
Last updated: October 20, 2006
Last verified: October 2006
  Purpose
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
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Criteria
Subjects with femoral vascular anastomosis and bleeding suture holes after vessel reconstruction with a PTFE prosthesis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163592

Locations
Austria
Landeskrankenhaus Innsbruck
Innsbruck, Tirol, Austria, 6020
General Hospital (AKH) Salzburg
Salzburg, Austria, 5020
Germany
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
Investigators
Principal Investigator: Thomas Bürger, MD University Clinics of Magdeburg, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00163592     History of Changes
Other Study ID Numbers: 530301 
Study First Received: September 8, 2005
Last Updated: October 20, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Ministry for Health and Women

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

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on December 05, 2016