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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN86152982

Enrollment

Registered

2008-02-08

Start date

2007-10-19

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 solu

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Intra- and postoperative transfusion requirements according to defined transfusion thresholds.	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026