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Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months

Authors:
Phil Edwards at London School of Hygiene and Tropical Medicine
Phil Edwards
M Arango
M Arango
M Arango
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Laura Balica at London North West University Healthcare NHS Trust
Laura Balica
Rowland Cottingham
Rowland Cottingham
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Abstract

MRC CRASH is a randomised controlled trial (ISRCTN74459797) of the effect of corticosteroids on death and disability after head injury. We randomly allocated 10,008 adults with head injury and a Glasgow Coma Scale score of 14 or less, within 8 h of injury, to a 48-h infusion of corticosteroid (methylprednisolone) or placebo. Data at 6 months were obtained for 9673 (96.7%) patients. The risk of death was higher in the corticosteroid group than in the placebo group (1248 [25.7%] vs 1075 [22.3%] deaths; relative risk 1.15, 95% CI 1.07-1.24; p=0.0001), as was the risk of death or severe disability (1828 [38.1%] vs 1728 [36.3%] dead or severely disabled; 1.05, 0.99-1.10; p=0.079). There was no evidence that the effect of corticosteroids differed by injury severity or time since injury. These results lend support to our earlier conclusion that corticosteroids should not be used routinely in the treatment of head injury.
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Final results of MRC CRASH, a randomised placebo-controlled trial of ...
Edwards, Phil;Arango, Miguel;Balica, Laura;Cottingham, Rowland;et al
The Lancet; Jun 4-Jun 10, 2005; 365, 9475; ProQuest Hospital Collection
pg. 1957
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
... The risk of death within 6 months with corticosteroid use was 25.7% vs. 22.3% with placebo (95% CI 1.07-1.24; p = 0.0001) [114]. Similar findings were present when comparing the corticosteroid group vs. placebo for risk of death or severe injury with 38.1% vs. 36.3%, ...
... respectively (95% CI 0.99-1.10; p = 0.079) [114]. When comparing subgroups, the effect of corticosteroids was not affected by the severity of the injury or the time of the injury [113]. ...
... Roberts et al. [113] Edwards et al. [114] Trials showed an increased risk of death or severe disability in the group of patients who received steroids compared to controls. Kostron et al. [120] Xiong et al. [70] Langham et al. [121] Despite their use in clinical practice to attempt to prevent secondary injury, a review of 6 randomized control trials demonstrated no statistically significant benefit of calcium channel blockers in reducing death and severe disability in TBI patients. ...
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... Despite the lack of convincing RCT data for efficacy, IVMP remains in common usage internationally [36]. The CRASH study, published in 2005 recruited 10,008 patients examined within less than 8 h after TBI, randomising them to placebo or 11.6 g intravenous methylprednisolone over the first 24 h, followed by 21.2 g over the second 48 h [37]. Patients were more likely to have an outcome of death and the composite outcome of death or severe disability when treated with corticosteroids than with placebo. ...
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