PMID: 8594222Oct 1, 1995Paper

Pitfalls and advances from the international tirilazad trial in moderate and severe head injury

Journal of Neurotrauma
L F Marshall, S B Marshall

Abstract

This manuscript reviews current experience with a large-scale clinical trial of the nonglucocorticoid 21-aminosteroid compound, tirilazad mesylate (U-74,006F). The trial itself now encompasses 15 countries with all central coordination conducted in the Data Coordinating Center at the University of California, San Diego. To date, the conduct of this trial has shown that diverse groups of clinicians in multiple countries have been able to work together to adhere to a tightly defined research protocol. Despite the success in initiating and conducting this trial, however, there have been several unanticipated problems that have complicated its progress. In this regard, difficulties have been associated with the use of mean Glasgow coma scores for data analysis. Similarly, a prospective identification of the risk variables was found necessary to preclude the potential for serious errors in data analysis. Lastly, a differential effect of the drug was noted in women compared to men in the European subarachnoid hemorrhage trial where a significant improvement in outcome was observed in males. This differential response appears to be linked to drug metabolism, but the problem may be further compounded by improper dosing because of failu...Continue Reading

References

Mar 1, 1988·Journal of Neurosurgery·E D HallJ M Braughler
Mar 1, 1988·Stroke; a Journal of Cerebral Circulation·E D Hall, P A Yonkers
Aug 1, 1988·Stroke; a Journal of Cerebral Circulation·E D HallJ M Braughler

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Citations

Apr 1, 1997·Bulletin of the American College of Surgeons·J E Wilberger
Jul 2, 2005·Expert Opinion on Investigational Drugs·L T Dunn
Apr 22, 2015·Journal of Neurotrauma·F Anthony WillyerdRobert S B Clark
Jul 11, 2003·Clinics in Sports Medicine·David O Okonkwo, James R Stone
Feb 24, 2001·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·H HuangA K Salahudeen
Jan 27, 2012·Neurologia Medico-chirurgica·Minoru ShigemoriUNKNOWN Guidelines Committee on the Management of Severe Head Injury, Japan Society of Neurotraumatology
Nov 25, 1997·Annals of the New York Academy of Sciences·E M DoppenbergR Bullock

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