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

Heinrich-Heine University, Duesseldorf

Status and phase: Withdrawn; Phase 2

Conditions: Blood Loss, Surgical

Treatments: Drug: Haemate HS; Other: NaCl-solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00618293

BI8021_5101

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

intravenous infusion of Haemate (dosage dependent on body weight)

Treatment:

Drug: Haemate HS

2

Placebo Comparator group

Description:

intravenous infusion of 0.9% NaCl solution

Treatment:

Other: NaCl-solution