The MRC CRASH Trial: study design, baseline data, and outcome in 1000 randomised patients in the pilot phase
The MRC CRASH Trial: study design, baseline data, and outcome in 1000 randomised patients in the pilot phase
复制标题
MRC CRASH 试验：试验阶段 1000 名随机患者的研究设计、基线数据和结果
DOI：
10.1136/emj.19.6.510
复制
发表时间：
2002
影响因子：
3.1
通讯作者：
D. Yates
中科院分区：
文献类型：
--
作者：
Phil Edwards;Barbara Farrell;G. Lomas;R. Mashru;N. Ritchie;Ian Roberts;P. Sandercock;Jonathan Wasserberg;D. Yates
目的：目的：检测一项大规模多中心随机对照试验的设计和可行性，以评价脑损伤后大剂量皮质类固醇输注的有效性和安全性。评估是否可以招募大量患者，并在受伤后8小时内进行治疗，然后在6个月内进行随访。方法：随机安慰剂对照的多中心试验，在严重头部损伤后48小时皮质类固醇输注。所有在住院期间观察到GCS为14或更低（最高评分为15分）且在受伤后8小时内的头部受伤成年人都有资格参加试验。MRC CRASH试验初步阶段入组的1000例患者的基线和结局数据（两个治疗组合并）分析。结果：14个国家的52家医院参加了试点阶段，平均每家医院每月招募一名患者。在1000例随机化患者中，330例（33%）轻度脑损伤，289例（29%）中度脑损伤，381例（38%）重度脑损伤。71%的患者在受伤后3小时内接受了随机分组。已知991例（99%）患者受伤后两周的结局，其中170例（17%）患者死亡。在撰写本文时，前500名患者的6个月随访已接近完成。500例患者中有465例（93%）的生命状态已知，其中97例（21%）死亡。根据格拉斯哥结局量表，已知500例患者中438例（88%）的功能状态：21%死亡，17%重度残疾，22%中度残疾，34%恢复良好。结论：试验程序被证明是可行的，在受伤后8小时内，急诊科招募了各种各样的病人。使用简单的结果测量，可以成功地随访大量患者。
Objectives: To test the design and feasibility of a large scale multicentre randomised controlled trial evaluating the efficacy and safety of a high dose corticosteroid infusion after head injury. To assess whether large numbers of patients could be enrolled and treated within eight hours from injury and then followed up at six months. Methods: Randomised placebo controlled multicentre trial of a 48 hour corticosteroid infusion after significant head injury. All head injured adults who were observed while in hospital to have GCS of 14 or less (out of a maximum score of 15), and who were within eight hours of the injury, were eligible for trial entry. Analysis of baseline and outcome data (for both treatment groups combined) for 1000 patients enrolled in the pilot phase of the MRC CRASH Trial. Results: Fifty two hospitals in 14 countries participated in the pilot phase, recruiting an average of one patient per hospital per month. Of the 1000 randomised patients, 330 (33%) had mild head injury, 289 (29%) had moderate head injury, and 381 (38%) had severe head injury. Seven hundred and nine (71%) patients were randomised within three hours of injury. Outcome at two weeks from injury was known for 991 (99%) patients, of whom 170 (17%) patients died. At the time of writing, six month follow up for the first 500 patients was nearly complete. Vital status was known for 465 (93%) of the 500 patients, of whom 97 (21%) had died. Functional status based on the Glasgow Outcome Scale was known for 438 (88%) of the 500 patients: 21% were dead, 17% were severely disabled, 22% were moderately disabled, and 34% had made a good recovery. Conclusions: The trial procedures proved practicable and a wide variety of patients were recruited in the emergency department within eight hours of injury. Using simple outcome measures, large numbers of patients can be successfully followed up.