Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260052
Status:
WITHDRAWN
Last Update Posted:
2015-08-24
First Post:
2005-11-29
Brief Title:
Erythropoietin Effects After Traumatic Brain Injury
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Phase II Study of the Effects of Erythropoietin on Neuronal Cell Death in Traumatic Brain Injury Patients
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI has left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if the early administration of erythropoietin to patients sustaining traumatic brain injury will reduce secondary brain injury
Detailed Description:
Traumatic brain injury occurs with alarming frequency in the United States and is associated with significant morbidity mortality and economic as well as emotional consequences Since the initial traumatic event produces irreparable primary brain injury the goal in care of the head injured patient focuses upon the prevention of secondary brain injury Currently the only clinical strategies available to prevent secondary brain injury relate to the maintenance of adequate cerebral blood flow and regulation of intracranial pressures
Now there is substantial laboratory evidence indicating that secondary neuronal cell death is reduced by the use of recombinant human erythropoietin EPO in a time-dependent fashion These data suggest that strategies utilizing EPO during the resuscitative phase of head injured patients could improve neurologic outcome
This is a randomized double-blind placebo-controlled single-center trial All blunt trauma patients over 18 years of age with an admission GCS between 9 and 13 and evidence of traumatic brain injury TBI on CT will be eligible After obtaining informed consent patients will be randomized to receive EPO 40000 Units IV or placebo to be administered within 6 hours of injury
Patients will have baseline day of injury and daily serum S-100B and NSE levels measured until 5 days after injury Demographic and clinical data to be obtained will include age gender head AIS ISS admission and ICU GCS daily mean ICP and CPP when ICP is monitored number and nature of ICP lowering interventions and daily mean PaCO2 The primary outcome measures are S-100B and NSE levels in patients receiving EPO compared to those receiving placebo Secondary outcome measures will include ICU LOS GCS at ICU discharge 3-month and 6-month Glascow Outcome Score and in-hospital mortality
Now there is substantial laboratory evidence indicating that secondary neuronal cell death is reduced by the use of recombinant human erythropoietin EPO in a time-dependent fashion These data suggest that strategies utilizing EPO during the resuscitative phase of head injured patients could improve neurologic outcome
This is a randomized double-blind placebo-controlled single-center trial All blunt trauma patients over 18 years of age with an admission GCS between 9 and 13 and evidence of traumatic brain injury TBI on CT will be eligible After obtaining informed consent patients will be randomized to receive EPO 40000 Units IV or placebo to be administered within 6 hours of injury
Patients will have baseline day of injury and daily serum S-100B and NSE levels measured until 5 days after injury Demographic and clinical data to be obtained will include age gender head AIS ISS admission and ICU GCS daily mean ICP and CPP when ICP is monitored number and nature of ICP lowering interventions and daily mean PaCO2 The primary outcome measures are S-100B and NSE levels in patients receiving EPO compared to those receiving placebo Secondary outcome measures will include ICU LOS GCS at ICU discharge 3-month and 6-month Glascow Outcome Score and in-hospital mortality
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