Recruiting
Phase 2

FEIBA vs. FFP

Sponsor:

Northwell Health

Code:

NCT07032792

Conditions

Cardiac Disease

Surgery

Bleeding

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FEIBA

FFP

Study Details

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.

Conditions

Cardiac Disease

Surgery

Bleeding

Study ID

NCT07032792

Start date

Nov 3, 2025

Status verified date

Mar, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FEIBA

active comparator: FFP

Interventions

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.

FFP

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kristine McGowan

516-881-7035kmcgowan@northwell.edu

Locations

North Shore University Hospital

Recruiting

Manhasset, New York, United States, 11030

More Information

Sponsor

Northwell Health

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-03-11.