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

Blood Loss, Surgical Clinical Trial

— HAVAS  

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00618293
• Other study ID #: BI8021_5101
• Status: Withdrawn
• Phase: Phase 2
• First received: February 8, 2008
• Last updated: January 3, 2012
• Start date: January 2008
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Blood Loss, Surgical

Intervention

Drug:
• Haemate HS
intravenous infusion of Haemate (dosage dependent on body weight)

Other:
• NaCl-solution
intravenous infusion of 0.9%NaCl-Solution

Locations

Country	Name	City	State
Germany	Klinik für Kardiovaskuläre Chirurgie	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	CSL Behring

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessment of adverse events and viral safety		1.perioperative 2. during hospital admission 3. within 90 days after surgery	Yes