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Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis

NCT00618293 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-01-05

No results posted yet for this study

Summary

Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).

Conditions

  • Blood Loss, Surgical

Interventions

DRUG

Haemate HS

intravenous infusion of Haemate (dosage dependent on body weight)

OTHER

NaCl-solution

intravenous infusion of 0.9%NaCl-Solution

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Peter Feindt, Prof. Dr. med. · Klinik für Kardiovaskuläre Chirurgie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-07-31
Completion
2011-07-31

Countries

  • Germany

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 NCT00618293 on ClinicalTrials.gov