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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT03341156
Eligibility Criteria:
Inclusion Criteria:
* Be willing and able to provide written informed consent.
* Be at least 18 years of age.
* Patients with or without ventricular assist device (VAD) undergoing heart transplantation
* Patients who have been on warfarin for at least 72 hours before cardiopulmonary bypass procedures for heart transplantation.
* International normalization ration (INR) greater than or equal to 1.5
* Body temperature greater than 35.0 degrees Celsius.
* Blood pH greater than 7.2
* Hemoglobin greater than 7.0 mg/dL.
Exclusion Criteria:
* Treatment with clopidogrel, prasugrel, or ticagrelor within 5 days prior to study surgery.
* Known or suspected thrombophilia such as factor V Leiden, hereditary antithrombin III deficiency, heparin-induced thrombocytopenia, disseminated intravascular coagulation.
* Ischemic or thromboembolic events within 6 weeks of study surgery.
* Known allergy/anaphylaxis to prothrombin complex concentrate or albumin.
* Any indication that a potential subject did not comprehend the study restrictions, procedures. or consequences therein an informed consent cannot be convincingly given.
* Patients on respiratory support including extracorporeal membrane oxygenation (ECMO) .
* Life expectancy less than 48 hours.
* Excluded at the discretion of the surgeon based upon surgical safety precautions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03341156
Study Brief:
Protocol Section:
NCT03341156