Study Results
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Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2003-07-31
2010-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Erythropoietin administration
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Principal Investigators
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Ram Nirula, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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03-264
Identifier Type: -
Identifier Source: org_study_id
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