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

Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis)

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).

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