Methylprednisolone or tirilazad mesylate administration after acute spinal cord injury: 1-year follow up

Results of the third National Acute Spinal Cord Injury Randomized Controlled Trial

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  • 1 Departments of Epidemiology and Public Health, Neurology and Neurosurgery, Yale University School of Medicine, New Haven, Connecticut; University of Maryland, Baltimore, Maryland; Sunnybrook Medical Center, Toronto, Ontario, Canada; Toronto Western Hospital, Toronto, Ontario, Cananda, Washington Hospital Center, Washington, D.C.; University of Iowa Hospitals and Clinics, Iowa City, Iowa; University of California at San Diego, San Diego, California; Henry Ford Hospital, Detroit, Michigan; Medical University of South Carolina, Charleston, South Carolina; Barrow Neurological Institute, Phoenix, Arizona; University of California at Davis, Davis, California; Allegheny General Hospital, Pittsburgh, Pennsylvania; University of Washington—Harborview Medical Center, Seattle, Washington; and New York University—Bellevue Medical Center, New York, New York
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Object. A randomized double-blind clinical trial was conducted to compare neurological and functional recovery and morbidity and mortality rates 1 year after acute spinal cord injury in patients who had received a standard 24-hour methylprednisolone regimen (24MP) with those in whom an identical MP regimen had been delivered for 48 hours (48MP) or those who had received a 48-hour tirilazad mesylate (48TM) regimen.

Methods. Patients for whom treatment was initiated within 3 hours of injury showed equal neurological and functional recovery in all three treatment groups. Patients for whom treatment was delayed more than 3 hours experienced diminished motor function recovery in the 24MP group, but those in the 48MP group showed greater 1-year motor recovery (recovery scores of 13.7 and 19, respectively, p = 0.053). A greater percentage of patients improving three or more neurological grades was also observed in the 48MP group (p = 0.073). In general, patients treated with 48TM recovered equally when compared with those who received 24MP treatments. A corresponding recovery in self care and sphincter control was seen but was not statistically significant. Mortality and morbidity rates at 1 year were similar in all groups.

Conclusions. For patients in whom MP therapy is initiated within 3 hours of injury, 24-hour maintenance is appropriate. Patients starting therapy 3 to 8 hours after injury should be maintained on the regimen for 48 hours unless there are complicating medical factors.

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Contributor Notes

Address reprint requests to: Michael B. Bracken, Ph.D., Department of Epidemiology and Public Health, Yale University School of Medicine, 60 College Street, P.O. Box 208034, New Haven, Connecticut 06520–8034.
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