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FEIBA and Use of Blood Products in Cardiac Surgery

Phase 1
Completed
Conditions
Cardiovascular Disease
Interventions
Drug: Normal Saline
Drug: FEIBA
Registration Number
NCT02577614
Lead Sponsor
Oregon Health and Science University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Normal SalineNormal SalineSingle dose of NaCl 0.9%
FEIBAFEIBASingle dose of commercially available FEIBA
Primary Outcome Measures
NameTimeMethod
Volume of blood products transfused (mL)30 days

-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)

Secondary Outcome Measures
NameTimeMethod
Number of thrombotic or thromboembolic events30 days

- thrombotic or thromboembolic events are defined as any event of deep venous thrombosis, pulmonary embolism, stroke, or MI

Number of patients with post-operative bleeding requiring surgical hemostasis30 days
Duration of post-operative ventilation, ICU and hospital length of stay30 days
Number of deaths30 days

Trial Locations

Locations (1)

Oregon Health and Science University

🇺🇸

Portland, Oregon, United States

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