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.
- head injury
- corticosteroid infusion
- randomised controlled trial
- pilot phase
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Conflicts of interest: The CRASH Trial is sponsored by the Medical research Council (MRC) and not the manufactures of methyprednisolone. MRC funding covers meetings and central organisational costs only. Pharmacia Corporation are donoting drug and placebo, but the design, management, and finance of the study are entirely independent of them.
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