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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT03152461
Eligibility Criteria:
Inclusion Criteria:
* Subject is ≥18 years
* Subject is scheduled for either 1) cardiac or vascular surgery utilizing cardiopulmonary bypass (CPB) or 2) orthopedic surgery including major deformity correction spine surgery
* Subject has a cardiac assist device and is hospitalized for any procedure
* Subject underwent cardiac, vascular or orthopedic surgery and presents with acute bleeding or suspected hypercoagulability in a post-surgical unit
* Subject is undergoing emergency cardiac, vascular or orthopedic surgery
* Subject is willing to participate and he/she has signed a consent form
Exclusion Criteria:
* Subject is unable to provide written informed consent
* Subject is younger than 18 years
* Subject is incarcerated at the time of the study
* Subject is pregnant
* Subject is currently enrolled in a study that might confound the result of the proposed study
* Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03152461
Study Brief:
Protocol Section:
NCT03152461