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NCT Number: NCT07032792

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

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.

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Key information

Conditions

Cardiac Disease Bleeding Cardiovascular Diseases Heart Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location status: Recruiting

Location contact

Kristine McGowan

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Total post-treatment pRBC transfusion within 24 hours of surgery

    Time frame: 24 hours

Secondary outcomes

  1. 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.

  2. Total units of posttreatment platelet transfusion within 24 hours of surgery

    Time frame: 24 hours

  3. Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery

    Time frame: 24 hours

  4. Total units of FEIBA given within 24 hours of surgery

    Time frame: 24 hours

  5. Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery

    Time frame: 24 hours

  6. Total mLs of chest tube output within 12 hours of surgery

    Time frame: 12 hours

    This is being assessed as chest tube output may be an indicator of ongoing bleeding

  7. Incidence of adverse postoperative events

    Time frame: Perioperative

    This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis.

  8. Length of intubation

    Time frame: Perioperative

  9. Length of hospital stay

    Time frame: From date of hospital admission until date of discharge or up to 3 months, whichever comes first.

  10. 30-day mortality

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Kristine McGowan

CONTACT

[email protected]

516-881-7035

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 24, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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