Actively Recruiting
Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
Led by Northwell Health · Updated on 2026-03-11
140
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- 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 cardiopulmonary bypass
- Presence of microvascular bleeding requiring factor transfusion as decided by the care team
You will not qualify if you...
- Contraindication or known severe allergic reaction to FEIBA or its components
- Disseminated intravascular coagulation
- Acute thrombosis or embolism, including heart attack
- Pregnancy
- Unable or unwilling to consent for themselves
- Known blood clotting disorders
- Previous coronary artery bypass surgery
- History of transplants or ventricular assist device use
- Use of extracorporeal membrane oxygenation support
- Heparin-induced thrombocytopenia
- Refusal to receive blood products even when medically necessary
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
Research Team
K
Kristine McGowan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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