FEIBA versus fresh frozen plasma as first-line treatment for bleeding after cardiac surgery

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

This Phase 2 trial will test whether FEIBA works better than fresh frozen plasma (FFP) as the first treatment for adults who develop coagulopathic microvascular bleeding after non-emergency cardiac surgery with cardiopulmonary bypass.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 1 site (Manhasset, New York)
• Trial ID: NCT07032792 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial compares FEIBA (a bypassing agent) with standard fresh frozen plasma (FFP) as the first-line transfusion for coagulopathic microvascular bleeding following cardiopulmonary bypass in non-emergent, non-coronary cardiac surgery. Eligible adults who develop microvascular bleeding requiring factor transfusion are treated with either FEIBA or FFP and monitored for control of bleeding and clinical outcomes. Key exclusions include disseminated intravascular coagulation, acute thrombosis or embolism, known coagulation disorders, pregnancy, or patients on ECMO or with VADs or recent transplants. The trial is conducted at a single center (North Shore University Hospital) and aims to determine whether FEIBA provides faster or more complete correction of coagulopathy and reduces bleeding-related complications compared with FFP.

Who should consider this trial

Good fit: Adults (18+) undergoing non-emergency, non-coronary cardiac surgery with cardiopulmonary bypass who develop microvascular coagulopathic bleeding requiring factor transfusion and can consent are ideal candidates.

Not a fit: Patients with active thrombosis or embolism, disseminated intravascular coagulation, known coagulation disorders, pregnancy, those needing CABG, transplants, VADs, or ECMO, or those unable to consent are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, FEIBA could stop coagulopathic bleeding faster and reduce the need for additional blood products, reoperation, and bleeding-related complications after cardiac surgery.

How similar studies have performed: Some observational reports and small series have suggested benefit of FEIBA for refractory surgical bleeding, but randomized data in the cardiac surgery setting are limited, so this application is relatively novel.

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

Where this trial is running

Manhasset, New York

• North Shore University Hospital — Manhasset, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Pey-Jen Yu — Northwell Health
• Study coordinator: Kristine McGowan

Conditions: Cardiac Disease, Surgery, Bleeding