8
Participants
Start Date
August 31, 2011
Primary Completion Date
December 31, 2013
Study Completion Date
December 31, 2013
Antithrombin (Recombinant)
Single dose of antithrombin (recombinant) to be given prior to initiation of cardiopulmonary bypass. Intravenous dose determined by following formula: ATIII dose given to patient = \[(1.0 Units/mL - patient's measured ATIII concentration in Units/mL) X weight (kg) X 80 mL/kg\] X (1 mL/175 Units)
Placebo
Single dose of placebo (0.9% NaCl) to be given prior to initiation of cardiopulmonary bypass. Intravenous dose determined by following formula: Placebo dose given to patient = \[(1.0 Units/mL - patient's measured ATIII concentration in Units/mL) X weight (kg) X 80 mL/kg\] X (1 mL/175 Units)
Children's Hospital of Wisconsin, Milwaukee
Collaborators (2)
Children's National Research Institute
OTHER
rEVO Biologics
INDUSTRY
Medical College of Wisconsin
OTHER