Erythropoetin Neuroprotection for Neonatal Cardiac Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00513240
• Date of registration: 07/08/2007
• Prospective Registration: No
• Primary sponsor: Baylor College of Medicine
• Public title: Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
• Scientific title: Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
• Date of first enrolment: September 2006
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00513240
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Dean B. Andropoulos, M.D.
• Affiliation: Baylor College of Medicine/Texas Children's Hospital

Key inclusion & exclusion criteria

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, or multiple fetal loss (3 or more
spontaneous abortions).



Age minimum: N/A
Age maximum: 30 Days
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Arch Hypoplasia or Interruption

Congenital Heart Disease

Hypoplastic Left Heart Syndrome

Transposition of the Great Arteries

Intervention(s)

Drug: Erythropoetin

Drug: Normal saline

Primary Outcome(s)

Relative Difference in Total Maturity Score (TMS) From Preoperative Brain MRI to 7 Day Postoperative MRI [Time Frame: 7 days postoperatively.]

Scores on Bayley Scales of Infant Development III at Age 1 Years. [Time Frame: 1 year postoperatively]

Secondary Outcome(s)

EEG Seizure Burden in the First 72 Postoperative Hours. (Total Minutes of EEG Seizures). [Time Frame: 72 hours postoperatively.]

Pharmacokinetics of High Dose Erythropoetin: 7 Erythropoetin Levels in First 24 Hours After First Dose (Maximum EPO Plasma Concentration) [Time Frame: 24 hours after first EPO dose.]

Secondary ID(s)

R21HD5550101

0942

IND #100011

1R21HD055501-01

Not Assigned

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

The Dana Foundation

Results

• Results available: Yes
• Date Posted: 19/05/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00513240