Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedStudy Start
First participant enrolled
November 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
March 11, 2026
March 1, 2026
3 years
April 21, 2025
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Total post-treatment pRBC transfusion within 24 hours of surgery
24 hours
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
FEIBA
EXPERIMENTALFFP
ACTIVE COMPARATORInterventions
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.
Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
Study Sites (1)
North Shore University Hospital
Manhasset, New York, 11030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pey-Jen Yu
Northwell Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2025
First Posted
June 24, 2025
Study Start
November 3, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2029
Last Updated
March 11, 2026
Record last verified: 2026-03