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NCT00490295 · ClinicalTrials.gov registry record
Biomarkers for Detection of Brain Ischemia
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 10
- Enrollment target
NCT00490295: Completed study, sponsored by Emory University.
NCT00490295 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00490295 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
Brain injury occurs in one-quarter to one-half of congenital heart defect infants during the perioperative period. A blood test using a biomarker to diagnose brain injury would be important. Postoperative cerebral ischemia may be decreased by inotropic support, ventilation, medical management aimed at increasing oxygen delivery to the brain. Currently there are no FDA approved blood tests to assess brain ischemia in infants undergoing cardiac surgery. Specific Aim 1: We will prospectively study 10 neonates (\< 30 days of age) undergoing cardiac surgery utilizing cardiopulmonary bypass for arterial switch operation or Norwood operation to determine the specificity and sensitivity of a blood test for brain injury. This aim will be accomplished by analyzing blood samples for S-100 and NSE drawn prior to surgery, once each day following cardiac surgery as long as the patient remains in the intensive care unit (maximum 5 days)and at the time of postoperative brain magnetic resonance imaging. The S-100B and NSE values will then be correlated with brain magnetic resonance imaging studies before cardiac surgery and at following cardiac surgery. Hypothesis: We expect the concentration of S-100B and NSE will be significantly higher in the blood of neonates with congenital heart disease who have documented brain injury on brain magnetic resonance imaging (MRI). Furthermore, we predict that the blood levels of S-100B and NSE may correlate to clinical outcome (time to extubation, hospital discharge, neurodevelopmental outcome at 6 months of age). Specific Aim 2: We will prospectively study these neonates at 6 months following cardiac surgery to determine a correlation between neurodevelopment and concentration of S-100B and NSE. To achieve this specific aim, a blood sample for S-100B and NSE and neurodevelopmental testing will be done at 6 months following cardiac surgery. Hypothesis: We expect neonates with elevated S-100B and NSE and abnormal brain magnetic resonance imag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-01 |
What the finished NCT00490295 record still lists
NCT00490295 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00490295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00490295 about?
NCT00490295 is a clinical study titled "Biomarkers for Detection of Brain Ischemia". Brain injury occurs in one-quarter to one-half of congenital heart defect infants during the perioperative period. A blood test using a biomarker to diagnose brain injury would be important. Postoperative cerebral ischemia may be decreased by inotropic support, ventilation, medical management aimed...
What is the current status of trial NCT00490295?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2008-03. Estimated completion is 2010-01.
Who is sponsoring clinical trial NCT00490295?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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