Contact information
Type
Scientific
Primary contact
Dr Rainer Zotz
ORCID ID
Contact details
Department of Hemostasis and Transfusion Medicine
Heinrich Heine University Medical Center
Moorenstrasse 5
Duesseldorf
D-40225
Germany
+49(0)211 8117474
Nicola.Moeller@med.uni-duesseldorf.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BI8021_5101
Study information
Scientific title
Acronym
HAVAS-Study
Study hypothesis
Evaluation of the efficacy and safety of Haemate HS in this clinical setting
Ethics approval
Approved by the Ethics Committee of the Heinrich Heine University Medical Center (Duesseldorf, Germany) on 25 April 2007. First amendment approved on 28 November 2007.
Study design
Two-arm, randomised, double-blind controlled clinical study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Severe intraoperative hemorrhage during aortic-valve replacement
Intervention
Intervention group: Intraoperative infusion Haemate HS 500/1000 IU (vWF/F VIII:C concentrate), time of infusion according to inclusion criteria.
Control group: Intravenous infusion of 0.9% NaCl solution (100 ml)
Intervention type
Drug
Phase
Not Specified
Drug names
Haemate HS (intraoperative infusion)
Primary outcome measures
Intra- and postoperative transfusion requirements according to defined transfusion thresholds.
Secondary outcome measures
1. Requirement of rethoracotomy, assessed during patients stay at the intensive care unit
2. Surgeons' subjective rating of therapeutic efficacy after application of Haemate HS or placebo (classification of bleeding after therapy as "better", "equal" or "worse")
3. Survival (perioperative mortality, mortality during hospital stay, mortality within a 90 day period following surgery)
4. Duration of treatment on intensive care ward
5. Adverse events and therapy-related side effects, assessed within the first 10 days after surgery. A second assessment is carried out after 3 month (at day 90)
Overall trial start date
19/10/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis (mean transvalvular gradient >50 mmHg) with severe bleeding during aortic-valve replacement
2. Age >18 years.
3. Written informed consent.
4. All patients that fulfill at least one of the following criteria 15 minutes after the end of extracorporal circulation and application of protamine:
4.1. Excessive bleeding without surgical explanation according to the surgeons' impression (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon. Classification as "excessive" bleeding leads to recruitment to the study).
4.2. Drainage volume >40 ml in 5 minutes following application of protamine and thorax closure.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 patients (20 per arm)
Participant exclusion criteria
1. Participation in other interventional studies that potentially impair the interpretation of results
2. History suggestive for inherited or acquired bleeding disorder
3. Written informed consent not to be obtained
4. Active endocarditis
5. Concomitant coronary heart disease
6. Agents impairing platelet function at the time of surgery
7. Pregnancy
8. Known or suspected intolerance against Haemate HS
9. Previous thromboembolic complications
10. Known hepatitis B, hepatitis C or HIV infection
11. Known or suspected intolerance against standard medication (e.g., heparin)
12. Emergency surgery within the last 7 days
13. Previous chemotherapy
Recruitment start date
19/10/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Hemostasis and Transfusion Medicine
Duesseldorf
D-40225
Germany
Sponsor information
Organisation
Heinrich Heine University Duesseldorf (Germany)
Sponsor details
c/o Dr Rainer B. Zotz
Department of Hemostasis and Transfusion Medicine
Heinrich Heine University Medical Center
Moorenstrasse 5
Duesseldorf
D-40225
Germany
+49 (0)211 8117474
zotz@med.uni-duesseldorf.de
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
CSL Behring GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary