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

Femoral Vascular Anastomosis Clinical Trial

Official title:

Non- Interventional Study of Tissucol® for Hemostasis in Subjects With Femoral Vascular Anastomosis Undergoing Vascular Reconstruction With PTFE Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163592
• Other study ID #: 530301
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: October 20, 2006
• Start date: September 2003
• Est. completion date: February 2004

Study information

• Verified date: October 2006
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Federal Ministry for Health and Women
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2004
• Gender: Both
• Age group: N/A and older

Eligibility

Subjects with femoral vascular anastomosis and bleeding suture holes after vessel reconstruction with a PTFE prosthesis

Study Design

Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Femoral Vascular Anastomosis

Intervention

Drug:
• Tissucol®

Procedure:
• Control: Conventional treatment, i.e. compression with swabs

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Innsbruck	Innsbruck	Tirol
Austria	General Hospital (AKH) Salzburg	Salzburg
Germany	Leonberg Hospital, Department of Vascular Surgery	Leonberg
Germany	University Clinics of Magdeburg, Department of Vascular Surgery	Magdeburg
Germany	Klinikum Nürnberg Süd, Department of Vascular Surgery	Nürnberg

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

Austria,  Germany,