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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.