Erythropoietin Effects After Traumatic Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Medical College of Wisconsin.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Association for the Surgery of Trauma
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00260052
First received: November 29, 2005
Last updated: January 17, 2007
Last verified: October 2005

November 29, 2005
January 17, 2007
July 2003
Not Provided
neuronal cell death marker levels of NSE and S100B
Same as current
Complete list of historical versions of study NCT00260052 on ClinicalTrials.gov Archive Site
mortality, Glascow Outcome Score at 3 and 6 months, number of ICP lowering interventions
Same as current
Not Provided
Not Provided
 
Erythropoietin Effects After Traumatic Brain Injury
Phase II Study of the Effects of Erythropoietin on Neuronal Cell Death in Traumatic Brain Injury Patients

To determine if the early administration of erythropoietin to patients sustaining traumatic brain injury will reduce secondary brain injury.

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  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 (40,000 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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Traumatic Brain Injury
Drug: Erythropoietin administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
86
December 2006
Not Provided

Inclusion Criteria:

  • Age > 17, Head CT shows intracranial hemorrhage < 6 hours after injury, GCS<13 consented

Exclusion Criteria:

  • nonsurvivable injuries for more then 48 hours, CPR in the field, patients already on erythropoietin
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00260052
03-264, 529-03
Not Provided
Not Provided
Medical College of Wisconsin
American Association for the Surgery of Trauma
Principal Investigator: Ram Nirula, MD, MPH Medical College of Wisconsin
Medical College of Wisconsin
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP