Study Stopped
No patient met the criteria for inclusion in the study.
Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis
HAVAS
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)
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 8, 2008
CompletedFirst Posted
Study publicly available on registry
February 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJanuary 5, 2012
January 1, 2012
2.5 years
February 8, 2008
January 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Assessment of adverse events and viral safety
1.perioperative 2. during hospital admission 3. within 90 days after surgery
Study Arms (2)
1
ACTIVE COMPARATORintravenous infusion of Haemate (dosage dependent on body weight)
2
PLACEBO COMPARATORintravenous infusion of 0.9% NaCl solution
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heinrich-Heine University, Duesseldorflead
- CSL Behringcollaborator
Study Sites (1)
Klinik für Kardiovaskuläre Chirurgie
Düsseldorf, 40225, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Feindt, Prof. Dr. med.
Klinik für Kardiovaskuläre Chirurgie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 8, 2008
First Posted
February 20, 2008
Study Start
January 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2011
Last Updated
January 5, 2012
Record last verified: 2012-01