NCT00260052

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

6.5 years

First QC Date

November 29, 2005

Last Update Submit

August 21, 2015

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • neuronal cell death marker levels of NSE and S100B

Secondary Outcomes (1)

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

Interventions

Erythropoietin administrationDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 17, Head CT shows intracranial hemorrhage \< 6 hours after injury, GCS\<13 consented

You may not qualify if:

  • nonsurvivable injuries for more then 48 hours, CPR in the field, patients already on erythropoietin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (9)

  • 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.

    PMID: 12042091BACKGROUND

  • 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.

    PMID: 8971763BACKGROUND

  • 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.

    PMID: 10366194BACKGROUND

  • 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.

    PMID: 8706759BACKGROUND

  • 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.

    PMID: 11883842BACKGROUND

  • 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.

    PMID: 11395856BACKGROUND

  • 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.

    PMID: 11812906BACKGROUND

  • 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.

    PMID: 11020484BACKGROUND

  • 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.

    PMID: 9539790BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Ram Nirula, MD, MPH

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

July 1, 2003

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

US(1)