FEIBA and Use of Blood Products in Cardiac Surgery

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT02577614

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: FEIBA Drug: Normal Saline	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FEIBA Single dose of commercially available FEIBA	Drug: FEIBA Administration of FEIBA after cardiopulmonary bypass Other Names: Anti-Inhibitor Coagulant Complex
Placebo Comparator: Normal Saline Single dose of NaCl 0.9%	Drug: Normal Saline Administration of placebo after cardiopulmonary bypass Other Names: NaCl 0.9%

Arm

Intervention/Treatment

Experimental: FEIBA

Single dose of commercially available FEIBA

Drug: FEIBA

Administration of FEIBA after cardiopulmonary bypass

Other Names:

Anti-Inhibitor Coagulant Complex

Placebo Comparator: Normal Saline

Single dose of NaCl 0.9%

Drug: Normal Saline

Administration of placebo after cardiopulmonary bypass

Other Names:

NaCl 0.9%

Outcome Measures

Primary Outcome Measures

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

Number of thrombotic or thromboembolic events [30 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 hemostasis [30 days]
Duration of post-operative ventilation, ICU and hospital length of stay [30 days]
Number of deaths [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.