Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations

Andrew I.R. Maas; Ewout W. Steyerberg; Gordon D. Murray; Ross Bullock; Alexander Baethmann; Lawrence F. Marshall; Graham M. Teasdale

doi:10.1097/00006123-199906000-00076

Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations

Andrew I.R. Maas, Ewout W. Steyerberg, Gordon D. Murray, Ross Bullock, Alexander Baethmann, Lawrence F. Marshall, Graham M. Teasdale

Neurological Surgery

Research output: Contribution to journal › Review article

125 Scopus citations

Abstract

AN OVERVIEW OF the results of recent trials of neuroprotective agents in head injury is presented. None of the trials showed efficacy in the general population of patients with a severe head injury. A critical analysis of the possible reasons for this failure is given. Specific attention is focused on the heterogeneity of the patient population, the importance of baseline prognostic indicators, and the problems caused by the distribution of outcome and the dichotomization of these outcomes in the Glasgow Outcome Scale. Recommendations are presented for consideration in the design and analysis of future trials in head injury.

Original language	English (US)
Pages (from-to)	1286-1298
Number of pages	13
Journal	Neurosurgery
Volume	44
Issue number	6
DOIs	https://doi.org/10.1097/00006123-199906000-00076
State	Published - Jun 1 1999

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Keywords

Clinical trials
Head injury
Neuroprotection
Outcome
Prognosis
Statistical analysis

ASJC Scopus subject areas

Clinical Neurology
Surgery

Cite this

Maas, A. I. R., Steyerberg, E. W., Murray, G. D., Bullock, R., Baethmann, A., Marshall, L. F., & Teasdale, G. M. (1999). Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations. Neurosurgery, 44(6), 1286-1298. https://doi.org/10.1097/00006123-199906000-00076

Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations. / Maas, Andrew I.R.; Steyerberg, Ewout W.; Murray, Gordon D.; Bullock, Ross; Baethmann, Alexander; Marshall, Lawrence F.; Teasdale, Graham M.

In: Neurosurgery, Vol. 44, No. 6, 01.06.1999, p. 1286-1298.

Research output: Contribution to journal › Review article

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Access to Document

10.1097/00006123-199906000-00076