FEIBA and Use of Blood Products in Cardiac Surgery

Completed · Phase 1 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT02577614

Run by

Oregon Health and Science University

People needed

12

Starts

2016-02-01

Expected to finish

2020-03-01

Last updated by the study team

2020-07-14

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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