While there is a desperate need for effective treatments for acute spinal cord injury (SCI), the clinical validation of novel therapeutic interventions is severely hampered by the need to recruit relatively large numbers of patients into clinical trials for sufficient statistical power. While a centre might annually admit 100 acute SCI patients, only a fraction may satisfy the basic inclusion criteria for an acute clinical trial, which typically requires patients of a certain injury severity (eg ASIA A), within a specific time window (eg. 12 hours from injury), and without other major injuries or conditions that would cloud the baseline neurologic assessment. This study was conducted to define that “fraction” of SCI patients that would theoretically satisfy standard inclusion criteria of an acute clinical trial. Using a local database, we reviewed patients admitted to our Level 1 trauma center with a complete (ASIA A) or an incomplete (ASIA B, C and D) acute SCI involving bony spinal levels between C0 and sacrum. All patients admitted over the 4 year period from 2005 to 2009 were reviewed. Demographic information and data about the patients' SCI and other injuries were reviewed. We then determined how many of the total number of SCI patients would be eligible for enrolment into a hypothetical acute clinical trial that required a valid baseline assessment of neurologic impairment, and an enrolment window of either 12 hours, 24 hours, or 48 hours.Introduction
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