FEIBA and Use of Blood Products in Cardiac Surgery (FEIBA)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Drug: FEIBA; Drug: Normal Saline

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cardiopulmonary Bypass; Transfusion; Deep Hypothermic Circulatory Arrest; Aortic Valve Repair; Coronary Re-Implantation; Factor VIII Inhibitor Bypass Activity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Anti-inhibitor coagulant complex; Coagulants
• Other Study ID Numbers: 11975