FEIBA and Use of Blood Products in Cardiac Surgery

• Status: Completed
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to evaluate the feasibility of the prophylactic administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to demonstrate the potential role of FEIBA administration in reducing the need for allogeneic transfusion to treat refractory coagulopathy in high risk patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Anti-inhibitor coagulant complex; Coagulants; Factor VIII

Criteria

Inclusion Criteria:

• Age 18 or older

• Elective aortic or aortic valve procedures, coronary re-implantation (Bentall) with cardiopulmonary bypass, and/or deep hypothermic circulatory arrest.

• Written informed consent

Exclusion Criteria:

• Contraindications to the administration of FIEBA or known anaphylactic or severe hypersensitivity reactions to FEIBA or any of its components

• Disseminated intravascular coagulation (DIC)

• Acute thrombosis or embolism, including myocardial infarction

• Pregnant women

• Decisionally impaired adults

• Prisoners

• Expressed unwillingness or are otherwise deemed unable to provide written informed consent.