Erythropoietin Effects After Traumatic 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.

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