CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Erythropoetin +1 moredrug
Likely dose
Erythropoetin 500 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00513240
NCT00513240Phase 2Completed
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Erythropoetin Neuroprotection for Neonatal Cardiac Surgery

Baylor College of Medicine·interventional·Posted Aug 8, 2007·Updated Feb 7, 2020

In Brief

A Phase 2 clinical trial evaluating Erythropoetin and Normal saline for Congenital Heart Disease and 3 related conditions. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease, Hypoplastic Left Heart Syndrome, Transposition of the Great Arteries, Aortic Arch Hypoplasia or Interruption
CountriesUnited States
CollaboratorsThe Dana Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2007
Enrollment StartSep 1, 2006
Primary CompletionSep 1, 2012
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 18.9 years ago

Interventions

Erythropoetindrug

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

Normal salinedrug

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. .