Status:
WITHDRAWN
Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
CSL Behring
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Eligibility Criteria
Inclusion
- patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement
- Caucasian
- written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)
Exclusion
- active endocarditis
- history suggestive for inherited oe acquired bleeding disorder
- concomitant coronary heart disease
- agents impairing platelet function up to 14 days before surgery
- Pregnancy
- inherited platelet function
- known intolerance against HAEMATE HS
- previous thromboembolic complications
- Hepatitis B, C or HIV infection
- previous chemotherapy
- emergency surgery within the last 7 days
- weight \< 50 kg and \> 100 kg
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00618293
Start Date
January 1 2008
End Date
July 1 2011
Last Update
January 5 2012
Active Locations (1)
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1
Klinik für Kardiovaskuläre Chirurgie
Düsseldorf, Germany, 40225