NCT00163592

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2003

Shorter than P25 for all trials

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

October 23, 2006

Status Verified

October 1, 2006

First QC Date

September 8, 2005

Last Update Submit

October 20, 2006

Conditions

Femoral Vascular Anastomosis

Keywords

Vascular reconstructionPolytetraflouroethylene (PTFE) prosthesis

Interventions

Tissucol®DRUG
Control: Conventional treatment, i.e. compression with swabsPROCEDURE

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Subjects with femoral vascular anastomosis and bleeding suture holes after vessel reconstruction with a PTFE prosthesis

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

General Hospital (AKH) Salzburg

Salzburg, Salzburg, 5020, Austria

Location

Landeskrankenhaus Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Leonberg Hospital, Department of Vascular Surgery

Leonberg, 71229, Germany

Location

University Clinics of Magdeburg, Department of Vascular Surgery

Magdeburg, 39120, Germany

Location

Klinikum Nürnberg Süd, Department of Vascular Surgery

Nuremberg, 90340, Germany

Location

MeSH Terms

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Thomas Bürger, MD

    University Clinics of Magdeburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 14, 2005

Study Start

September 1, 2003

Study Completion

February 1, 2004

Last Updated

October 23, 2006

Record last verified: 2006-10

Locations

AU(2)DE(3)