- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260052
Erythropoietin Effects After Traumatic Brain Injury
Phase II Study of the Effects of Erythropoietin on Neuronal Cell Death in Traumatic Brain Injury Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
neuronal cell death marker levels of NSE and S100B
|
Secondary Outcome Measures
Outcome Measure |
---|
mortality, Glascow Outcome Score at 3 and 6 months, number of ICP lowering interventions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ram Nirula, MD, MPH, Medical College of Wisconsin
Publications and helpful links
General 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. doi: 10.1089/089771502753754037.
- 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. doi: 10.1016/s0306-4522(96)00306-5.
- 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. doi: 10.1097/00004647-199906000-00007.
- 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. doi: 10.1111/j.1432-1033.1996.0494u.x.
- 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. doi: 10.3171/jns.2002.96.3.0565.
- 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. doi: 10.1016/s0093-7754(01)90216-7.
- Cerami A, Brines M, Ghezzi P, Cerami C, Itri LM. Neuroprotective properties of epoetin alfa. Nephrol Dial Transplant. 2002;17 Suppl 1:8-12. doi: 10.1093/ndt/17.suppl_1.8.
- 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. doi: 10.1016/s0014-2999(00)00691-9.
- 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. doi: 10.1073/pnas.95.8.4635.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-264
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
Queen Mary University of LondonCompleted
-
Northeastern UniversityBrandeis UniversityRecruitingTraumatic Brain Injury | Mild Traumatic Brain Injury | TBI | Moderate Traumatic Brain InjuryUnited States
Clinical Trials on Erythropoietin administration
-
UMC UtrechtDutch Heart FoundationCompletedRenal Insufficiency, Chronic | Heart Failure, CongestiveNetherlands
-
University of CambridgeHoffmann-La Roche; Roche Foundation of Anemia Research (RoFAR, Switzerland)CompletedAneurysmal Subarachnoid HemorrhageUnited Kingdom
-
Bundang CHA HospitalLG Life SciencesCompleted
-
Chugai PharmaceuticalCompletedChemotherapy Induced Anemia
-
Angde Biotech Pharmaceutical Co., Ltd.Recruiting
-
NICHD Neonatal Research NetworkNational Center for Research Resources (NCRR)CompletedAnemia, Neonatal | Infant, Small for Gestational Age | Infant, Premature | Infant, Low Birth Weight | Infant, NewbornUnited States
-
Fatih Sultan Mehmet Training and Research HospitalDr. Lutfi Kirdar Kartal Training and Research HospitalCompleted
-
Shenyang Sunshine Pharmaceutical Co., LTD.Unknown
-
VA Office of Research and DevelopmentTerminatedAtherosclerosis | Anemia | CKD | CardiovascularUnited States
-
Tianjin SinoBiotech Ltd.Completed