A Phase 2 interventional study of FEIBA and FFP in Cardiac Disease, Surgery and Bleeding, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Northwell Health · Phase 2, Interventional, and Treatment
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: FEIBA
Drug: FFP
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.
Total post-treatment pRBC transfusion within 24 hours of surgery
Time frame: 24 hours
Total pRBC transfusion after administration of study drug
Time frame: 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
Time frame: 24 hours
Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery
Time frame: 24 hours
Total units of FEIBA given within 24 hours of surgery
Time frame: 24 hours
Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery
Time frame: 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
Time frame: 12 hours
Incidence of adverse postoperative events
This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis.
Time frame: Perioperative
Length of intubation
Time frame: Perioperative
Length of hospital stay
Time frame: From date of hospital admission until date of discharge or up to 3 months, whichever comes first.
30-day mortality
Time frame: 30 days
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