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

History of Changes

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:

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Erythropoietin Epoetin Alfa

U.S. FDA Resources

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

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:

Narayan RK, Michel ME, Ansell B, Baethmann A, Biegon A, Bracken MB, Bullock MR, Choi SC, Clifton GL, Contant CF, Coplin WM, Dietrich WD, Ghajar J, Grady SM, Grossman RG, Hall ED, Heetderks W, Hovda DA, Jallo J, Katz RL, Knoller N, Kochanek PM, Maas AI, Majde J, Marion DW, Marmarou A, Marshall LF, McIntosh TK, Miller E, Mohberg N, Muizelaar JP, Pitts LH, Quinn P, Riesenfeld G, Robertson CS, Strauss KI, Teasdale G, Temkin N, Tuma R, Wade C, Walker MD, Weinrich M, Whyte J, Wilberger J, Young AB, Yurkewicz L. Clinical trials in head injury. J Neurotrauma. 2002 May;19(5):503-57. Review.

Morishita E, Masuda S, Nagao M, Yasuda Y, Sasaki R. Erythropoietin receptor is expressed in rat hippocampal and cerebral cortical neurons, and erythropoietin prevents in vitro glutamate-induced neuronal death. Neuroscience. 1997 Jan;76(1):105-16.

Bernaudin M, Marti HH, Roussel S, Divoux D, Nouvelot A, MacKenzie ET, Petit E. A potential role for erythropoietin in focal permanent cerebral ischemia in mice. J Cereb Blood Flow Metab. 1999 Jun;19(6):643-51.

Yamaji R, Okada T, Moriya M, Naito M, Tsuruo T, Miyatake K, Nakano Y. Brain capillary endothelial cells express two forms of erythropoietin receptor mRNA. Eur J Biochem. 1996 Jul 15;239(2):494-500.

Grasso G, Passalacqua M, Sfacteria A, Conti A, Morabito A, Mazzullo G, De VG, Buemi M, Macri B, Tomasello F. Does administration of recombinant human erythropoietin attenuate the increase of S-100 protein observed in cerebrospinal fluid after experimental subarachnoid hemorrhage? J Neurosurg. 2002 Mar;96(3):565-70.

Cerami A, Brines ML, Ghezzi P, Cerami CJ. Effects of epoetin alfa on the central nervous system. Semin Oncol. 2001 Apr;28(2 Suppl 8):66-70. Review.

Cerami A, Brines M, Ghezzi P, Cerami C, Itri LM. Neuroprotective properties of epoetin alfa. Nephrol Dial Transplant. 2002;17 Suppl 1:8-12. Review.

Alafaci C, Salpietro F, Grasso G, Sfacteria A, Passalacqua M, Morabito A, Tripodo E, Calapai G, Buemi M, Tomasello F. Effect of recombinant human erythropoietin on cerebral ischemia following experimental subarachnoid hemorrhage. Eur J Pharmacol. 2000 Oct 13;406(2):219-25.

Sakanaka M, Wen TC, Matsuda S, Masuda S, Morishita E, Nagao M, Sasaki R. In vivo evidence that erythropoietin protects neurons from ischemic damage. Proc Natl Acad Sci U S A. 1998 Apr 14;95(8):4635-40.

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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

Wounds and Injuries
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

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