Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery

NCT ID: NCT07032792

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2029-06-30

Brief Summary

Coagulopathic-induced bleeding after cardiopulmonary bypass in cardiac surgery patients is common and is associated with adverse outcomes in cardiac surgery. The hypothesis of the study is that FEIBA will be a more effective treatment than standard of care (FFP) in cardiac surgery patients who have coagulopathic-induced bleeding. This study is being conducted to determine the efficacy of FEIBA versus FFP as first line therapy in correcting coagulopathic induced microvascular bleeding in cardiac surgery patients.

Conditions

Cardiac Disease; Surgery; Bleeding

Study Design

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

Study Groups

FEIBA

Group Type: EXPERIMENTAL

FEIBA

Intervention Type: DRUG

Subjects randomized to FEIBA will receive up to 2 vials of 500U of FEIBA through a preexisting central line at a rate that does not exceed 2 units per kg of body weight per minute for the study intervention.

FFP

Group Type: ACTIVE_COMPARATOR

FFP

Intervention Type: DRUG

Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.

Interventions

FEIBA

Subjects randomized to FEIBA will receive up to 2 vials of 500U of FEIBA through a preexisting central line at a rate that does not exceed 2 units per kg of body weight per minute for the study intervention.

Intervention Type: DRUG

FFP

Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 years or above
• Undergoing nonemergent non-coronary cardiac surgery with the use of cardiopulmonary bypass
• Patient with microvascular bleeding requiring factor transfusion as deemed by the patient care team

Exclusion Criteria

• Contraindication to the administration of FEIBA or known anaphylactic or severe hypersensitivity reaction to FEIBA or any of its components
• Disseminated intravascular coagulation
• Acute thrombosis or embolism, including myocardial infarction
• Pregnancy
• Patients that are not able or do not want to consent for themselves
• Patients with known coagulation disorders
• Patients who received coronary artery bypass surgery
• Patients who received transplants or ventricular assist devices
• Patients on extracorporeal membrane oxygenator support
• Patients with heparin induced thrombocytopenia
• Patients who do not wish to receive blood products even when it is deemed medically necessary

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

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pey-Jen Yu

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

North Shore University Hospital

Manhasset, New York, United States

Countries

United States

Central Contacts

Kristine McGowan

Role: CONTACT

kmcgowan@northwell.edu

516-881-7035

Facility Contacts

Kristine McGowan

Role: primary

Other Identifiers

24-0293

Identifier Type: -

Identifier Source: org_study_id