NCT00513240View on ClinicalTrials.gov

Erythropoetin Neuroprotection for Neonatal Cardiac Surgery

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2015

Conditions
Congenital Heart DiseaseHypoplastic Left Heart SyndromeTransposition of the Great ArteriesAortic Arch Hypoplasia or Interruption
Interventions
DRUG

Erythropoetin

Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2

DRUG

Normal saline

"Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2.~."

Trial Locations (1)

77030

Texas Children's Hospital, Houston

All Listed Sponsors
collaborator

The Dana Foundation

OTHER

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Baylor College of Medicine

OTHER

NCT00513240 - Erythropoetin Neuroprotection for Neonatal Cardiac Surgery | Biotech Hunter | Biotech Hunter