Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490295
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2007-06-20
Brief Title:
Biomarkers for Detection of Brain Ischemia
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Biomarkers for the Detection of Brain Ischemia in Neonates With Congenial Heart Disease Requiring Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 daysand 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 imaging documented in specific aim 1 to have a significant decline in neurodevelopment at 6 months after cardiac surgery
Long-term The long-term goal of this research is to diagnose brain ischemia in infants using a biomarker blood test
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 daysand 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 imaging documented in specific aim 1 to have a significant decline in neurodevelopment at 6 months after cardiac surgery
Long-term The long-term goal of this research is to diagnose brain ischemia in infants using a biomarker blood test
Detailed Description:
1 Ten full-term neonates 36 week gestation between 1-30 days of age who present for arterial switch operation or Norwood operation will have 2 ml of blood drawn prior to cardiac surgery 2 ml blood drawn each day after cardiac surgery as long as the patient remains in the intensive care unit with indwelling lines maximum of 5 days and 2 ml blood drawn on the day of the followup brain magnetic resonance imaging study if not within the maximum of 5 days to determine blood concentrations S100B and NSE
2 Brain magnetic resonance imaging MRI including T1 2 DWI spectroscopy and magnetic resonance angiography will be performed prior to cardiac surgery and following cardiac surgery in all study patients Timing of the follow-up brain magnetic resonance imaging including T1 2 DWI spectroscopy and magnetic resonance angiography will be based on stability of the patient as assessed by the attending physician Optimal timing for brain magnetic resonance imaging is 4 days postop
3 Maternal information including level of education medications and medical history will be obtained Two mls of blood will also be obtained from the mother to determine maternal blood concentrations of S100B and NSE
4 Study patient clinical variables including vital signs heart rate blood pressure respiratory rate systemic oxygen saturation by extremity pulse oximetry near infrared spectroscopy NIRS routine laboratory values will be obtained at the time of each study blood sample
5 Operative variables including cardiopulmonary bypass time aortic cross clamp time circulatory arrest time and hematocrit on bypass will be obtained Transfusion quantity of packed red blood cells fresh frozen plasma platelets and cryoprecipitate used in the operating room and in the cardiac intensive care unit will also be obtained
6 Outcome variables including length of mechanical ventilation hospital stay and gross neurological abnormalities clinical seizures will be obtained
Follow-up
7 All patients will have neurodevelopmental testing at 6 months after heart surgery
8 Another 2 mls of blood S100B and NSE will be obtained when the patient returns at 6 months for neurodevelopmental testing
2 Brain magnetic resonance imaging MRI including T1 2 DWI spectroscopy and magnetic resonance angiography will be performed prior to cardiac surgery and following cardiac surgery in all study patients Timing of the follow-up brain magnetic resonance imaging including T1 2 DWI spectroscopy and magnetic resonance angiography will be based on stability of the patient as assessed by the attending physician Optimal timing for brain magnetic resonance imaging is 4 days postop
3 Maternal information including level of education medications and medical history will be obtained Two mls of blood will also be obtained from the mother to determine maternal blood concentrations of S100B and NSE
4 Study patient clinical variables including vital signs heart rate blood pressure respiratory rate systemic oxygen saturation by extremity pulse oximetry near infrared spectroscopy NIRS routine laboratory values will be obtained at the time of each study blood sample
5 Operative variables including cardiopulmonary bypass time aortic cross clamp time circulatory arrest time and hematocrit on bypass will be obtained Transfusion quantity of packed red blood cells fresh frozen plasma platelets and cryoprecipitate used in the operating room and in the cardiac intensive care unit will also be obtained
6 Outcome variables including length of mechanical ventilation hospital stay and gross neurological abnormalities clinical seizures will be obtained
Follow-up
7 All patients will have neurodevelopmental testing at 6 months after heart surgery
8 Another 2 mls of blood S100B and NSE will be obtained when the patient returns at 6 months for neurodevelopmental testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None