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

Phase 2

Withdrawn

• Conditions: Blood Loss, Surgical
• Interventions: Drug: Haemate HS; Other: NaCl-solution

• Registration Number: NCT00618293
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-20
• Primary Completion: 2010-07
• Study Completion: 2011-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Haemate HS	intravenous infusion of Haemate (dosage dependent on body weight)
2	NaCl-solution	intravenous infusion of 0.9% NaCl solution

Primary Outcome Measures

Name	Time	Method
intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds	begin of surgery and 48h after administration of medication

Secondary Outcome Measures

Name	Time	Method
Assessment of adverse events and viral safety	1.perioperative 2. during hospital admission 3. within 90 days after surgery

Trial Locations

Locations (1)

Klinik für Kardiovaskuläre Chirurgie; 🇩🇪 Düsseldorf, Germany