Erythropoetin Neuroprotection for Neonatal Cardiac Surgery (NCT00513240) | Clinical Trial Compass
CompletedPhase 1/2
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
United States62 participantsStarted 2006-09
Plain-language 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.
Who can participate
Age range
1 Day – 30 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI
Timeframe: 7 days postoperatively.
2
Scores on Bayley Scales of Infant Development III at Age 1 Years.