ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by:
Baxter Healthcare Corporation

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
Femoral Vascular Anastomosis Drug: Tissucol® Procedure: Control: Conventional treatment, i.e. compression with swabs

Study Type : Observational
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
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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


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

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:
Hemostatics
Fibrin Tissue Adhesive
Coagulants