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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT07032792
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 years or above
* Undergoing nonemergent non-coronary cardiac surgery with the use of cardiopulmonary bypass
* Patient with microvascular bleeding requiring factor transfusion as deemed by the patient care team
Exclusion Criteria:
* Contraindication to the administration of FEIBA or known anaphylactic or severe hypersensitivity reaction to FEIBA or any of its components
* Disseminated intravascular coagulation
* Acute thrombosis or embolism, including myocardial infarction
* Pregnancy
* Patients that are not able or do not want to consent for themselves
* Patients with known coagulation disorders
* Patients who received coronary artery bypass surgery
* Patients who received transplants or ventricular assist devices
* Patients on extracorporeal membrane oxygenator support
* Patients with heparin induced thrombocytopenia
* Patients who do not wish to receive blood products even when it is deemed medically necessary
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07032792
Study Brief:
Protocol Section:
NCT07032792