Clinical trial NCT00260052: Erythropoietin Effects After Traumatic Brain Injury
Official title: Phase II Study of the Effects of Erythropoietin on Neuronal Cell Death in Traumatic Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2005-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: neuronal cell death marker levels of NSE and S100B
Secondary outcomes:
measure: mortality, Glascow Outcome Score at 3 and 6 months, number of ICP lowering interventions
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Ram Nirula, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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