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

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT07032792
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bleeding
  • Cardiac Disease
  • Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FEIBA — DRUG
    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.
  • FFP — DRUG
    Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.

Study Details

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.

Key Dates

Start date
Nov 3, 2025
Status verified
Mar 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FEIBA
  • Active Comparator: FFP

Primary Outcome Measure

Total post-treatment pRBC transfusion within 24 hours of surgery [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
North Shore University HospitalManhassetNew York11030
Kristine McGowan

Find similar trials in Manhasset, NY

By research site
North Shore University Hospital· Manhasset, NY

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