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

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.

Study Overview

• Status: Recruiting
• Conditions: Bleeding; Surgery; Cardiac Disease
• Intervention / Treatment: Drug: FEIBA; Drug: FFP

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kristine McGowan; Phone Number: 516-881-7035; Email: KMcGowan@northwell.edu

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Recruiting
      • North Shore University Hospital
      • Contact: Kristine McGowan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FEIBA	Drug: 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.
Active Comparator: FFP	Drug: FFP; Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total post-treatment pRBC transfusion within 24 hours of surgery	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality		30 days
Total pRBC transfusion after administration of study drug		From time of administration of study drug until time of discharge or up to 3 months, whichever comes first.
Total units of posttreatment platelet transfusion within 24 hours of surgery		24 hours
Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery		24 hours
Total units of FEIBA given within 24 hours of surgery		24 hours
Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery		24 hours
Total mLs of chest tube output within 12 hours of surgery	This is being assessed as chest tube output may be an indicator of ongoing bleeding	12 hours
Incidence of adverse postoperative events	This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis.	Perioperative
Length of intubation		Perioperative
Length of hospital stay		From date of hospital admission until date of discharge or up to 3 months, whichever comes first.

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Pey-Jen Yu, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Hemorrhage; anti-inhibitor coagulant complex
• Other Study ID Numbers: 24-0293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No