Progesterone in traumatic brain injury: time to move on to phase III trials
- PMID: 18522765
- PMCID: PMC2481452
- DOI: 10.1186/cc6899
Progesterone in traumatic brain injury: time to move on to phase III trials
Abstract
There are several candidate neuroprotective agents that have been shown in preclinical testing to improve outcomes following traumatic brain injury (TBI). Xiao and colleagues have performed an in hospital, double blind, randomized, controlled clinical trial utilizing progesterone in the treatment of patients sustaining TBI evaluating safety and long term clinical outcomes. These data, combined with the results of the previously published ProTECT trial, show progesterone to be safe and potentially efficacious in the treatment of TBI. Larger phase III trials will be necessary to verify results prior to clinical implementation. Clinical trials networks devoted to the study of TBI are vital to the timely clinical testing of these candidate agents and need to be supported.
Comment on
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Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial.Crit Care. 2008;12(2):R61. doi: 10.1186/cc6887. Epub 2008 Apr 30. Crit Care. 2008. PMID: 18447940 Free PMC article. Clinical Trial.
References
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- Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS, Lowery DW, Patel MM, Denson DD, Gordon AB, Wald MM, Gupta S, Hoffman SW, Stein DG. ProTect: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med. 2007;49:391–402. doi: 10.1016/j.annemergmed.2006.07.932. - DOI - PubMed
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