The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. Three small doses, 5 mg/kg each, will be available.
Contains no active ingredient and administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously.
Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients.
Number of units of transfused allogeneic blood products after cardiopulmonary bypass in the operating room (OR) and in the intensive care unit (ICU) on postoperative day (POD) 0 and 1.
Time frame: approximately 1 day postoperatively
Hospital length of stay
Number of days admitted to the hospital
Time frame: Through hospital discharge, approximately 3 days
Mortality
Total number of subject deaths
Time frame: Through hospital discharge, approximately 3 days
Intravascular and intracardiac thromboses
Number of subjects to experience intravascular and/or intracardiac thromboses up to POD 3
Time frame: approximately 3 days postoperatively
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