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

• 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

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

Secondary outcomes

• Total pRBC transfusion after administration of study drug [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 [24 hours]
• Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery [24 hours]
• Total units of FEIBA given within 24 hours of surgery [24 hours]
• Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery [24 hours]
• Total mLs of chest tube output within 12 hours of surgery [12 hours]: This is being assessed as chest tube output may be an indicator of ongoing bleeding
• Incidence of adverse postoperative events [Perioperative]: This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis.
• Length of intubation [Perioperative]
• Length of hospital stay [From date of hospital admission until date of discharge or up to 3 months, whichever comes first.]
• 30-day mortality [30 days]

Sex: All, ages: 18 Years to any

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

• Pey-Jen Yu, Principal investigator, Northwell Health