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
  Purpose

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


Condition Intervention Phase
Traumatic Brain Injury
Drug: Erythropoietin administration
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II Study of the Effects of Erythropoietin on Neuronal Cell Death in Traumatic Brain Injury Patients

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • neuronal cell death marker levels of NSE and S100B

Secondary Outcome Measures:
  • mortality, Glascow Outcome Score at 3 and 6 months, number of ICP lowering interventions

Estimated Enrollment: 86
Study Start Date: July 2003
Estimated Study Completion Date: December 2006
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  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260052

Locations
United States, Wisconsin
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
American Association for the Surgery of Trauma
Investigators
Principal Investigator: Ram Nirula, MD, MPH Medical College of Wisconsin
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00260052     History of Changes
Other Study ID Numbers: 03-264, 529-03
Study First Received: November 29, 2005
Last Updated: January 17, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014