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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
FEIBA
  • Drug: 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.
Active Comparator
FFP
  • Drug: FFP
    Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.

Recruiting Locations

North Shore University Hospital
Manhasset, New York 11030
Contact:
Kristine McGowan

More Details

Status
Recruiting
Sponsor
Northwell Health

Study Contact

Kristine McGowan
516-881-7035
kmcgowan@northwell.edu