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

NCT ID: NCT00163592

Last Updated: 2006-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Femoral Vascular Anastomosis

Keywords

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Vascular reconstruction Polytetraflouroethylene (PTFE) prosthesis

Study Design

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Study Time Perspective

OTHER

Interventions

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Tissucol®

Intervention Type DRUG

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Thomas Bürger, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinics of Magdeburg, Germany

Locations

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General Hospital (AKH) Salzburg

Salzburg, Salzburg, Austria

Site Status

Landeskrankenhaus Innsbruck

Innsbruck, Tyrol, Austria

Site Status

Leonberg Hospital, Department of Vascular Surgery

Leonberg, , Germany

Site Status

University Clinics of Magdeburg, Department of Vascular Surgery

Magdeburg, , Germany

Site Status

Klinikum Nürnberg Süd, Department of Vascular Surgery

Nuremberg, , Germany

Site Status

Countries

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Austria Germany

Other Identifiers

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530301

Identifier Type: -

Identifier Source: org_study_id