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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

intravenous infusion of Haemate (dosage dependent on body weight)

Group Type ACTIVE_COMPARATOR

Haemate HS

Intervention Type DRUG

intravenous infusion of Haemate (dosage dependent on body weight)

2

intravenous infusion of 0.9% NaCl solution

Group Type PLACEBO_COMPARATOR

NaCl-solution

Intervention Type OTHER

intravenous infusion of 0.9%NaCl-Solution

Interventions

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Haemate HS

intravenous infusion of Haemate (dosage dependent on body weight)

Intervention Type DRUG

NaCl-solution

intravenous infusion of 0.9%NaCl-Solution

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No