Combined Neurosurgical and Orthopaedic Spine Program (CNOSP), Department of Orthopaedics, International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, British Columbia, Canada.
J Clin Neurosci. 2012 Oct;19(10):1338-43. doi: 10.1016/j.jocn.2012.02.015. Epub 2012 Aug 24.
Clinical trials of experimental neuroprotective and neuroregenerative therapies for acute spinal cord injury (SCI) typically require large numbers of patients to be enrolled. An important factor in designing such trials is the number of patients that can be realistically recruited at a given institution. The total number of patients with acute SCI treated at a neurotrauma centre is typically considered when such a site becomes a recruiting centre for a clinical trial. However, only a fraction of patients may be truly eligible due to the inclusion and exclusion criteria of the trial. This study was conducted to estimate the proportion of patients with acute SCI who would theoretically satisfy basic inclusion criteria for such a hypothetical clinical trial. Using a local prospective database, we reviewed 406 patients with acute traumatic SCI admitted between 2005 and 2009. 259 of 406 patients (64%) presented within 12 hours of injury, 53 patients (13%) between 12 hours and 24 hours, and 30 patients (7%) between 24 hours and 48 hours. Patients were assessed on admission using the American Spinal Injury Association Impairment Scale: category A, 39% of patients; B, 11%; C, 17%; and D, 28%. The number of patients who presented with injuries or other conditions that would likely exclude them from enrolment was 30%. Thus, of a total of 406 patients with SCI admitted over four years, the number who would have been eligible for an acute clinical trial was disappointingly small. This study is the first to quantify this challenging aspect of conducting acute SCI clinical trials, and provides guidance for those planning such initiatives.
临床试验中，通常需要大量患者参与来评估实验性神经保护和神经再生疗法对急性脊髓损伤（SCI）的效果。设计此类试验的一个重要因素是在给定机构内可以实际招募的患者数量。当一个机构成为临床试验的招募中心时，通常会考虑该机构治疗的急性 SCI 患者总数。然而，由于试验的纳入和排除标准，只有一部分患者可能真正符合条件。本研究旨在估计理论上有多少急性 SCI 患者符合此类假设临床试验的基本纳入标准。通过使用当地前瞻性数据库，我们回顾了 2005 年至 2009 年期间收治的 406 例急性创伤性 SCI 患者。406 例患者中有 259 例（64%）在受伤后 12 小时内就诊，53 例（13%）在 12 至 24 小时内就诊，30 例（7%）在 24 至 48 小时内就诊。患者入院时采用美国脊髓损伤协会损伤分级（ASIA）进行评估：A 级，39%；B 级，11%；C 级，17%；D 级，28%。有 30%的患者因受伤或其他情况可能被排除在试验之外。因此，在四年内总共收治的 406 例 SCI 患者中，适合参加急性临床试验的患者数量少得令人失望。这项研究首次定量分析了开展急性 SCI 临床试验的这一具有挑战性的方面，为计划开展此类研究的人员提供了指导。
