Erythropoetin Neuroprotection for Neonatal Cardiac Surgery

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Congenital Heart Disease, Hypoplastic Left Heart Syndrome, Transposition of the Great Arteries, Aortic Arch Hypoplasia or Interruption

In brief

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.

Key facts

Study ID

NCT00513240

Run by

Baylor College of Medicine

People needed

62

Starts

2006-09-01

Expected to finish

2015-09-01

Last updated by the study team

2020-02-07

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates (<30 days) undergoing cardiac surgery with cardiopulmonary bypass will be enrolled.
• Inclusion criteria include patients with:
• single ventricle: hypoplastic left heart syndrome or variant undergoing Norwood Stage I or Sano palliation (SV group);
• patients with D-transposition of the great vessels with or without ventricular septal defect (VSD) undergoing arterial switch operation with VSD closure if needed (ASO group); and
• patients with interrupted or hypoplastic aortic arch with intracardiac defects (VSD, ASD, or subaortic stenosis) who are undergoing complete 2- ventricle repair including aortic arch advancement(AAA group), any other 2 ventricle lesion scheduled for complex anatomic repair.

You may not qualify if…

• Gestational age less than 35 weeks at birth
• Weight less than 2 kg
• Known recognizable dysmorphic syndrome
• Surgery not requiring cardiopulmonary bypass
• Preoperative cardiac arrest requiring chest compressions for greater than 3 minutes
• Inability to enroll the patient greater than 12 hours preoperatively
• Aortic crossclamping is not used
• CPB times are anticipated to be less than 60 minutes
• A nadir temperature on bypass greater than 25° C is planned.
• Presence of known contraindications to EPO administration-sustained systolic blood pressure >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).

Where it is running

• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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