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

Completed

Conditions: Severe intraoperative hemorrhage during aortic-valve replacement
Circulatory System

Registration Number: ISRCTN86152982

Lead Sponsor: Heinrich Heine University Duesseldorf (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra- and postoperative transfusion requirements according to defined transfusion thresholds.

Secondary Outcome Measures

Name	Time	Method
1. Requirement of rethoracotomy, assessed during patients stay at the intensive care unit <br>2. Surgeons' subjective rating of therapeutic efficacy after application of Haemate HS or placebo (classification of bleeding after therapy as better, equal or worse) <br>3. Survival (perioperative mortality, mortality during hospital stay, mortality within a 90 day period following surgery) <br>4. Duration of treatment on intensive care ward <br>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)