FEIBA and Use of Blood Products in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized Double Blind Placebo Controlled Pilot Trial

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: FEIBA
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FEIBA<br>Single dose of commercially available FEIBA | Drug: FEIBA<br>* Administration of FEIBA after cardiopulmonary bypass<br>* Other names: Anti-Inhibitor Coagulant Complex;|
| Placebo Comparator: Normal Saline<br>Single dose of NaCl 0.9% | Drug: Normal Saline<br>* Administration of placebo after cardiopulmonary bypass<br>* Other names: NaCl 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of blood products transfused (mL) | -Cumulative volume of blood products transfused, defined as the volume in mL of packed red blood cells, fresh frozen plasma, and platelets, after the administration of the study drug (mL) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of thrombotic or thromboembolic events | - thrombotic or thromboembolic events are defined as any event of deep venous thrombosis, pulmonary embolism, stroke, or MI | 30 days | 
| Number of patients with post-operative bleeding requiring surgical hemostasis |  | 30 days | 
| Duration of post-operative ventilation, ICU and hospital length of stay |  | 30 days | 
| Number of deaths |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Bypass, Aortic Valve Repair, Coronary Re-Implantation, Deep Hypothermic Circulatory Arrest, Factor VIII Inhibitor Bypass Activity, Transfusion