Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513240
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2007-08-07
Brief Title:
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2020-01
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 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
Detailed Description:
Hypothesis Erythropoetin EPO will protect the neonatal brain in the perioperative period for congenital heart surgery
Using a prospective randomized placebo-controlled double-blinded design the specific aims of this study are
1 To determine the effect of perioperative EPO on short and long term neurological outcomes in neonates undergoing cardiac surgery with an optimized cardiopulmonary bypass strategy
2 To determine EPO tolerability and safety with short term administration
3 To determine EPO pharmacokinetics in this population
4 To determine the relationship of neurological monitoring specifically NIRS to neurological outcomes with an optimized cardiopulmonary bypass technique in neonates that avoids deep hypothermic circulatory arrest and to determine if EPO affects this relationship
Protocol Neonates undergoing arterial switch Norwood or aortic arch advancementother complete 2 ventricle repair 35 weeks gestation and 20 kg are eligible
Preop day 1NIRS for 12-24 hours neuro exam and Study drug dose 1 EPO 500 unitskg or saline placebo 12-72 hours before surgery EPO Pharmacokinetic data for 25-50 consenting patients
Day of surgery Brain MRI immediately preop AnesthesiaCPB per our standard practice fentanyl 100-200 mcgkg midazolam isoflurane epsilon-aminocaproic acid 75 mgkg IV load to patient and CPB prime and 75 mgkghr infusion in OR with ACP guided by TCD pH stat hct 30-35 avoid DHCA
POD 1 Study drug dose 2 EPO 500 unitskg or saline placebo 24 hours after dose 2
For 72 hours postop NIRS monitoring All monitor data collected electronically
POD 3 Study drug dose 3 EPO 500 unitskg or saline placebo 48 hours after dose 3
7 days postop Brain MRI pentobarbital IV Neuro exam before discharge 3-6 months Brain MRI immediately before or after 2nd surgery or as outpatient IV pentobarb or propofolmidazolam-may use N2Osevo for induction cannot intubate if outpatient OR if cardiac MRI at same time any indicated anesthetic technique NIRS x 24h after 2nd surgery
1and 3 years Bayley Scales of Infant Development III 5 years Battery of neurodevelopmental tests
Early primary outcome variable MRI severity of injury score decrease by 25 Late outcome variable Bayley Scales of Infant Development score improvement by 18 at age 1 years
Sample size 60 patients stratified into 3 groups to give power 085 alpha 005 Expect to accrue 2-4 patients per month
Using a prospective randomized placebo-controlled double-blinded design the specific aims of this study are
1 To determine the effect of perioperative EPO on short and long term neurological outcomes in neonates undergoing cardiac surgery with an optimized cardiopulmonary bypass strategy
2 To determine EPO tolerability and safety with short term administration
3 To determine EPO pharmacokinetics in this population
4 To determine the relationship of neurological monitoring specifically NIRS to neurological outcomes with an optimized cardiopulmonary bypass technique in neonates that avoids deep hypothermic circulatory arrest and to determine if EPO affects this relationship
Protocol Neonates undergoing arterial switch Norwood or aortic arch advancementother complete 2 ventricle repair 35 weeks gestation and 20 kg are eligible
Preop day 1NIRS for 12-24 hours neuro exam and Study drug dose 1 EPO 500 unitskg or saline placebo 12-72 hours before surgery EPO Pharmacokinetic data for 25-50 consenting patients
Day of surgery Brain MRI immediately preop AnesthesiaCPB per our standard practice fentanyl 100-200 mcgkg midazolam isoflurane epsilon-aminocaproic acid 75 mgkg IV load to patient and CPB prime and 75 mgkghr infusion in OR with ACP guided by TCD pH stat hct 30-35 avoid DHCA
POD 1 Study drug dose 2 EPO 500 unitskg or saline placebo 24 hours after dose 2
For 72 hours postop NIRS monitoring All monitor data collected electronically
POD 3 Study drug dose 3 EPO 500 unitskg or saline placebo 48 hours after dose 3
7 days postop Brain MRI pentobarbital IV Neuro exam before discharge 3-6 months Brain MRI immediately before or after 2nd surgery or as outpatient IV pentobarb or propofolmidazolam-may use N2Osevo for induction cannot intubate if outpatient OR if cardiac MRI at same time any indicated anesthetic technique NIRS x 24h after 2nd surgery
1and 3 years Bayley Scales of Infant Development III 5 years Battery of neurodevelopmental tests
Early primary outcome variable MRI severity of injury score decrease by 25 Late outcome variable Bayley Scales of Infant Development score improvement by 18 at age 1 years
Sample size 60 patients stratified into 3 groups to give power 085 alpha 005 Expect to accrue 2-4 patients per month
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Not Assigned | OTHER_GRANT | Charles A Dana Foundation Brain and Immuno-Imaging Grant | httpsreporternihgovquickSearch1R21HD055501-01 |
| IND 100011 | OTHER | None | None |
| 0942 | OTHER_GRANT | None | None |
| 1R21HD055501-01 | NIH | None | None |