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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
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.
Subjects randomized to FFP will receive up to 2 units of FFP intravenously through a preexisting central line.
North Shore University Hospital
Manhasset, New York, United States
Total post-treatment pRBC transfusion within 24 hours of surgery
Time frame: 24 hours
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.
Total units of posttreatment platelet transfusion within 24 hours of surgery
Time frame: 24 hours
Total units of posttreatment cryoprecipitate transfusion within 24 hours of surgery
Time frame: 24 hours
Total units of FEIBA given within 24 hours of surgery
Time frame: 24 hours
Total units of Fresh Frozen Plasma (FFP) given within 24 hours of surgery
Time frame: 24 hours
Total mLs of chest tube output within 12 hours of surgery
This is being assessed as chest tube output may be an indicator of ongoing bleeding
Time frame: 12 hours
Incidence of adverse postoperative events
This can include thrombotic events, acute kidney injury, reoperation for bleeding, prolonged intubation, atrial fibrillation, anaphylaxis.
Time frame: Perioperative
Length of intubation
Time frame: Perioperative
Length of hospital stay
Time frame: From date of hospital admission until date of discharge or up to 3 months, whichever comes first.
30-day mortality
Time frame: 30 days
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