CompletedPhase 1

FEIBA and Use of Blood Products in Cardiac Surgery

United States12 participantsStarted 2016-02

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Volume of blood products transfused (mL)

Timeframe: 30 days

Trial details

NCT IDNCT02577614

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

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