Clinical trial NCT02577614: FEIBA and Use of Blood Products in Cardiac Surgery
Official title: Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized Double Blind Placebo Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Keywords: Cardiopulmonary Bypass
Aortic Valve Repair
Coronary Re-Implantation
Deep Hypothermic Circulatory Arrest
Factor VIII Inhibitor Bypass Activity
Transfusion
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Factor eight inhibitor bypassing activity (FEIBA) is currently approved for use in this country for the treatment of patients with Hemophilia and inhibitors at a dose of 50-100 units/kg. There is a large body of evidence demonstrating the safety and efficacy of FEIBA for Hemophilia patients with inhibitor and has a theoretical advantage compared to current blood product transfusion methods, as it replenishes multiple depleted factors that are lost with prolonged exposure to CPB.

This pilot study is a single center, randomized, double-blinded, placebo controlled trial assessing the feasibility and safety of factor eight inhibitor bypass activity (FEIBA) in patients undergoing major cardiovascular surgery requiring prolonged CPB. The study population will consist of adult patients undergoing elective cardiac surgery at OHSU. Twelve participants will randomly assigned to receive FEIBA or placebo during their surgical procedure.

Patients will be followed to review for adverse events while in the ICU, and up to four weeks after discharge.

Eligibility 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.

Primary outcomes:
measure: Volume of blood products transfused (mL)
timeFrame: 30 days
Secondary outcomes:
measure: Number of thrombotic or thromboembolic events
timeFrame: 30 days
measure: Number of patients with post-operative bleeding requiring surgical hemostasis
timeFrame: 30 days
measure: Duration of post-operative ventilation, ICU and hospital length of stay
timeFrame: 30 days
measure: Number of deaths
timeFrame: 30 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
citation: Sera VA, Stevens AE, Song HK, Rodriguez VM, Tibayan FA, Treggiari MM. Factor VIII inhibitor bypass activity (FEIBA) for the reduction of transfusion in cardiac surgery: a randomized, double-blind, placebo-controlled, pilot trial. Pilot Feasibility Stud. 2021 Jul 2;7(1):137. doi: 10.1186/s40814-021-00873-5.