Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates

PHASE1TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Postoperative Hemorrhage
Interventions
DRUG

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)

OTHER

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)

Trial Locations (1)

53226

Children's Hospital of Wisconsin, Milwaukee

All Listed Sponsors
collaborator

Children's National Research Institute

OTHER

collaborator

rEVO Biologics

INDUSTRY

lead

Medical College of Wisconsin

OTHER