Erythropoietin Effects After Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00260052
Recruitment Status : Withdrawn (PI has left institution)
First Posted : December 1, 2005
Last Update Posted : August 24, 2015
Information provided by (Responsible Party):
Medical College of Wisconsin

November 29, 2005
December 1, 2005
August 24, 2015
July 2003
January 2010   (Final data collection date for primary outcome measure)
neuronal cell death marker levels of NSE and S100B
Same as current
Complete list of historical versions of study NCT00260052 on Archive Site
mortality, Glascow Outcome Score at 3 and 6 months, number of ICP lowering interventions
Same as current
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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 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 (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.

Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Traumatic Brain Injury
Drug: Erythropoietin administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical College of Wisconsin
Medical College of Wisconsin
Not Provided
Principal Investigator: Ram Nirula, MD, MPH Medical College of Wisconsin
Medical College of Wisconsin
August 2015

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