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:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT00214656
Eligibility Criteria:
Inclusion Criteria:
* Patients with scheduled cardiac surgery undergoing the following procedures
* Double valve replacements or repair.
* Major thoracic aortic surgery including hypothermic circulatory arrest or descending aortic reconstruction.
* Valve repair or replacement in the setting of endocarditis
* Complex procedures requiring cardiopulmonary bypass duration anticipated to exceed 180 minutes in patients aged ³70 years
Exclusion Criteria:
* Patient unable to give informed consent
* Patient refusal
* Allergy to rVIIa
* Allergy to aprotinin or prior exposure within 6 months
* Pre-existing congenital coagulopathy
* Pre-existing hypercoagulable state
* Patients in inclusion criteria whose actual bypass time does not exceed 180 minutes
* Unresolved surgical bleeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00214656
Study Brief:
Protocol Section:
NCT00214656