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Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement

NCT00161902 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2006-10-23

No results posted yet for this study

Summary

The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D is superior to standard treatment in reducing blood loss in subjects undergoing total hip replacement with cement-free hip prostheses.

Conditions

  • Hip Replacement Surgery

Interventions

DRUG

Fibrin Sealant Vapor-Heated Solvent/Detergent-treated

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Florian Gottsauner-Wolf, MD · A. ö. Krankenhaus Krems, Austria

  • Axel Rüter, MD · Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Completion
2003-03-31

Countries

  • Austria
  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00161902 on ClinicalTrials.gov