Anti-thrombin III (ATIII) vs Placebo in Children (<7mo) Undergoing Open Congenital Cardiac Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

June 27, 2016

Study Completion Date

July 1, 2016

Conditions
ATIII Deficiency
Interventions
DRUG

Anti-thrombin III

"Intraoperatively- (correcting to 100%) according to the following formula:~Units required = ((100%- baseline ATIII level\*%) X body weight)/1.4~* expressed as a % normal level based on functional ATIII assay"

OTHER

Placebo

Normal saline placebo

Trial Locations (1)

27708

Duke University, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Grifols Biologicals, LLC

INDUSTRY

lead

Duke University

OTHER