Condition category
Circulatory System
Date applied
07/12/2007
Date assigned
08/02/2008
Last edited
08/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes