Evaluation of Haemate HS for the treatment of severe intraoperative hemorrhage during aortic-valve replacement in patients with aortic-valve stenosis

ISRCTN	ISRCTN86152982
DOI	https://doi.org/10.1186/ISRCTN86152982
Secondary identifying numbers	BI8021_5101

Submission date: 07/12/2007
Registration date: 08/02/2008
Last edited: 08/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rainer Zotz
Scientific

Department of Hemostasis and Transfusion Medicine
Heinrich Heine University Medical Center
Moorenstrasse 5
Duesseldorf
D-40225
Germany

Phone	+49(0)211 8117474
Email	Nicola.Moeller@med.uni-duesseldorf.de

Study information

Study design	Two-arm, randomised, double-blind controlled clinical study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	HAVAS-Study
Study objectives	Evaluation of the efficacy and safety of Haemate HS in this clinical setting
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Haemate HS (intraoperative infusion)
Primary outcome measure	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 study start date	19/10/2007
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40 patients (20 per arm)
Key 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.
Key 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
Date of first enrolment	19/10/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Germany

Study participating centre

Department of Hemostasis and Transfusion Medicine

Duesseldorf
D-40225
Germany

Sponsor information

Heinrich Heine University Duesseldorf (Germany)
Not defined

c/o Dr Rainer B. Zotz
Department of Hemostasis and Transfusion Medicine
Heinrich Heine University Medical Center
Moorenstrasse 5
Duesseldorf
D-40225
Germany

Phone	+49 (0)211 8117474
Email	zotz@med.uni-duesseldorf.de
"ROR"	https://ror.org/024z2rq82

Funders

Funder type

Industry

CSL Behring GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan