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

Northwell Health

Status and phase: Not yet enrolling; Phase 2

Conditions: Cardiac Disease; Surgery; Bleeding

Treatments: Drug: FFP; Drug: FEIBA

Study type: Interventional

Funder types: Other

Identifiers

NCT07032792

24-0293

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

FEIBA

Experimental group

Treatment:

Drug: FEIBA

FFP

Active Comparator group

Treatment:

Drug: FFP