Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT00618293
Eligibility Criteria:
Inclusion Criteria:
* patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement
* Caucasian
* written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)
Exclusion Criteria:
* active endocarditis
* history suggestive for inherited oe acquired bleeding disorder
* concomitant coronary heart disease
* agents impairing platelet function up to 14 days before surgery
* Pregnancy
* inherited platelet function
* known intolerance against HAEMATE HS
* previous thromboembolic complications
* Hepatitis B, C or HIV infection
* previous chemotherapy
* emergency surgery within the last 7 days
* weight \< 50 kg and \> 100 kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00618293
Study Brief:
Protocol Section:
NCT00618293