Critical Appraisal
Study Design
a) CRASH 1 Trial was done to assess effect of IV corticosteroids (48h infusion of methylprednisolone v/s placebo) on death within 14 days in adults with clinically significant head injury.
b) Randomised trial-Allocation sequence based. Triple blinded study.
c)Study accounted for all study participants with intention to treat basis.The study was stopped early following interim unmasking of results by data monitoring and ethics committee.
Study Methodology
a) Triple blinded
b) Baseline characteristics of both groups are similar.
c) Study didn't collect any data regarding concurent interventions received apart from trial intervention.
Results
a) Primary Outcome : Death from any cause within 2 weeks of injury and death or disability at 6 months. Study also did a subgroup analysis based on time of injury and GCS at presentation.
b) Size of intervention and treatment group 5007 & 5001 respectively. Study reported similar complications in both group.
Usefulness of the study
a) This is a multicentric study done at 200 hospitals in 49 countries. Hence it has good representation of population.Study address a important question regarding the effect of corticosteroids in TBI.
From CRASH 1, a large Multicentric RCT it is clear that corticosteroids has no mortality benefit in
