The citicoline brain injury treatment (COBRIT) trial: design and methods

Ross Zafonte, William T. Friedewald, Shing M. Lee, Bruce Levin, Ramon Diaz-Arrastia, Beth Ansel, Howard Eisenberg, Shelly Timmons, Nancy Temkin, Thomas Novack, Joseph Ricker, Randall Merchant, Jack Jallo

Research output: Contribution to journalArticle

41 Citations (Scopus)

Abstract

Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established. Citicoline, a naturally occurring endogenous compound, offers the potential of neuroprotection, neurorecovery, and neurofacilitation to enhance recovery after TBI. Citicoline has a favorable side-effect profile in humans and several meta-analyses suggest a benefit of citicoline treatment in stroke and dementia. COBRIT is a randomized, double-blind, placebo-controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate, and severe TBI. In all, 1292 patients will be recruited over an estimated 32 months from eight clinical sites with random assignment to citicoline (1000mg twice a day) or placebo (twice a day), administered enterally or orally. Functional outcomes are assessed at 30, 90, and 180 days after the day of randomization. The primary outcome consists of a set of measures that will be analyzed as a composite measure using a global test procedure at 90 days. The measures comprise the following core battery: the California Verbal Learning Test II; the Controlled Oral Word Association Test; Digit Span; Extended Glasgow Outcome Scale; the Processing Speed Index; Stroop Test part 1 and Stroop Test part 2; and Trail Making Test parts A and B. Secondary outcomes include survival, toxicity, and rate of recovery.

Original languageEnglish (US)
Pages (from-to)2207-2216
Number of pages10
JournalJournal of Neurotrauma
Volume26
Issue number12
DOIs
StatePublished - Dec 1 2009

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Cytidine Diphosphate Choline
Brain Injuries
Stroop Test
Therapeutics
Word Association Tests
Placebos
Trail Making Test
Glasgow Outcome Scale
Verbal Learning
Random Allocation
Dementia
Meta-Analysis
Cause of Death
Survival Rate
Stroke
Traumatic Brain Injury
Clinical Trials
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Clinical Neurology

Cite this

Zafonte, R., Friedewald, W. T., Lee, S. M., Levin, B., Diaz-Arrastia, R., Ansel, B., ... Jallo, J. (2009). The citicoline brain injury treatment (COBRIT) trial: design and methods. Journal of Neurotrauma, 26(12), 2207-2216. https://doi.org/10.1089/neu.2009.1015
Zafonte, Ross ; Friedewald, William T. ; Lee, Shing M. ; Levin, Bruce ; Diaz-Arrastia, Ramon ; Ansel, Beth ; Eisenberg, Howard ; Timmons, Shelly ; Temkin, Nancy ; Novack, Thomas ; Ricker, Joseph ; Merchant, Randall ; Jallo, Jack. / The citicoline brain injury treatment (COBRIT) trial : design and methods. In: Journal of Neurotrauma. 2009 ; Vol. 26, No. 12. pp. 2207-2216.
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Zafonte, R, Friedewald, WT, Lee, SM, Levin, B, Diaz-Arrastia, R, Ansel, B, Eisenberg, H, Timmons, S, Temkin, N, Novack, T, Ricker, J, Merchant, R & Jallo, J 2009, 'The citicoline brain injury treatment (COBRIT) trial: design and methods', Journal of Neurotrauma, vol. 26, no. 12, pp. 2207-2216. https://doi.org/10.1089/neu.2009.1015

The citicoline brain injury treatment (COBRIT) trial : design and methods. / Zafonte, Ross; Friedewald, William T.; Lee, Shing M.; Levin, Bruce; Diaz-Arrastia, Ramon; Ansel, Beth; Eisenberg, Howard; Timmons, Shelly; Temkin, Nancy; Novack, Thomas; Ricker, Joseph; Merchant, Randall; Jallo, Jack.

In: Journal of Neurotrauma, Vol. 26, No. 12, 01.12.2009, p. 2207-2216.

Research output: Contribution to journalArticle

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T2 - design and methods

AU - Zafonte, Ross

AU - Friedewald, William T.

AU - Lee, Shing M.

AU - Levin, Bruce

AU - Diaz-Arrastia, Ramon

AU - Ansel, Beth

AU - Eisenberg, Howard

AU - Timmons, Shelly

AU - Temkin, Nancy

AU - Novack, Thomas

AU - Ricker, Joseph

AU - Merchant, Randall

AU - Jallo, Jack

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N2 - Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. Despite numerous prior clinical trials no standard pharmacotherapy for the treatment of TBI has been established. Citicoline, a naturally occurring endogenous compound, offers the potential of neuroprotection, neurorecovery, and neurofacilitation to enhance recovery after TBI. Citicoline has a favorable side-effect profile in humans and several meta-analyses suggest a benefit of citicoline treatment in stroke and dementia. COBRIT is a randomized, double-blind, placebo-controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome in patients with complicated mild, moderate, and severe TBI. In all, 1292 patients will be recruited over an estimated 32 months from eight clinical sites with random assignment to citicoline (1000mg twice a day) or placebo (twice a day), administered enterally or orally. Functional outcomes are assessed at 30, 90, and 180 days after the day of randomization. The primary outcome consists of a set of measures that will be analyzed as a composite measure using a global test procedure at 90 days. The measures comprise the following core battery: the California Verbal Learning Test II; the Controlled Oral Word Association Test; Digit Span; Extended Glasgow Outcome Scale; the Processing Speed Index; Stroop Test part 1 and Stroop Test part 2; and Trail Making Test parts A and B. Secondary outcomes include survival, toxicity, and rate of recovery.

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Zafonte R, Friedewald WT, Lee SM, Levin B, Diaz-Arrastia R, Ansel B et al. The citicoline brain injury treatment (COBRIT) trial: design and methods. Journal of Neurotrauma. 2009 Dec 1;26(12):2207-2216. https://doi.org/10.1089/neu.2009.1015