FEIBA and Use of Blood Products in Cardiac Surgery

NCT ID: NCT02577614

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-03-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FEIBA

Single dose of commercially available FEIBA

Group Type: EXPERIMENTAL

FEIBA

Intervention Type: DRUG

Administration of FEIBA after cardiopulmonary bypass

Normal Saline

Single dose of NaCl 0.9%

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Administration of placebo after cardiopulmonary bypass

Interventions

FEIBA

Administration of FEIBA after cardiopulmonary bypass

Intervention Type: DRUG

Normal Saline

Administration of placebo after cardiopulmonary bypass

Intervention Type: DRUG

Other Intervention Names

Anti-Inhibitor Coagulant Complex; NaCl 0.9%

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Miriam Treggiari

Clinical Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34215339 (View on PubMed)

Other Identifiers

11975

Identifier Type: -

Identifier Source: org_study_id