Phase 2
N=62
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Congenital Heart Disease · Hypoplastic Left Heart Syndrome · Transposition of the Great Arteries · Aortic Arch Hypoplasia or Interruption
Bottom Line
View on ClinicalTrials.gov: NCT00513240 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI — 12.1; 9.44 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erythropoetin (Drug); Normal saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI |
12.1; 9.44 | — |
| PRIMARY Scores on Bayley Scales of Infant Development III at Age 1 Years. |
101.4; 100.9; 106.3; 85.0; 92.0; 92.4 | — |
| SECONDARY EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures). |
0; 0 | — |
| SECONDARY Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose (Maximum EPO Plasma Concentration) |
6931 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Neonates ( 100, hemoglobin .18 g/dL, known allergy to EPO or one of its components
- Platelet count >600, 000 per dL, INR <0.8.
- Maternal history of major vascular thrombosis, or multiple fetal loss (3 or more spontaneous abortions).
Data sourced from ClinicalTrials.gov (NCT00513240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.