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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00163592
Enrollment
60
Registered
2005-09-14
Start date
2003-09-30
Completion date
2004-02-29
Last updated
2006-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Vascular Anastomosis

Keywords

Vascular reconstruction, Polytetraflouroethylene (PTFE) prosthesis

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.

Interventions

DRUGTissucol®
PROCEDUREControl: Conventional treatment, i.e. compression with swabs

Sponsors

Baxter Healthcare Corporation
Lead SponsorINDUSTRY

Study design

Time perspective
OTHER

Eligibility

Sex/Gender
ALL

Inclusion criteria

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

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026