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

• Status: Withdrawn
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborator: CSL Behring
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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