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The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial CRASH-2 trial collaborators  Lancet  2011; 377: 1096–101
Background CRASH-2 trial collaborators  Lancet  2010; 376: 23–32 Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial
Methods ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Eligibility criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Were all patients who entered the trial accounted for?
Were all patients analysed in the groups to which they were randomised?   ,[object Object]
Were measures  objective  or were the patients and clinicians kept “ blind ” to which treatment was being received?   ,[object Object]
Was the assignment of patients to treatments  randomised ?   ,[object Object],[object Object],[object Object]
Were the groups  similar  at the start of the trial?   ,[object Object]
Aside from the allocated treatment, were groups treated equally?
How large was the treatment effect? ,[object Object]
How large was the treatment effect? ,[object Object]
Absolute Risk Reduction (ARR)
Absolute Risk Reduction (ARR) ARR AC  = 0.16 – 0.145 = 0.015 or 1.5% ARR B  = 0.057 – 0.049 = 0.008 or 0.8%
Relative Risk Reduction (RRR)
Relative Risk Reduction (RRR) RRR AC  = 1 – 0.91 = 0.09 or 9% RRR B  = 1 – 0.85 = 0.15 or 15%
Number Needed to Treat (NNT)
Number Needed to Treat (NNT) NNT AC  = 1 / (0.16 – 0.145) = 67(40- 198 ) NNT B  = 1 / (0.057 – 0.049) = 125(69- 450)
Background to the exploratory analysis ,[object Object],[object Object],[object Object]
Intial PICO - Research Question ,[object Object],[object Object],[object Object],[object Object],[object Object]
Initial analysis
Initial analysis Post hoc change from <1
New PICO - Research Question ,[object Object],[object Object],[object Object],[object Object],[object Object]
Results
Patient characteristics by time to treatment
Patient characteristics by time to treatment
Patient characteristics by time to treatment
Patient characteristics by time to treatment
Patient characteristics by time to treatment ,[object Object]
Death due to bleeding by subgroup
Death due to all cause by subgroup
Will the results help me in caring for my patient?   ,[object Object],[object Object],[object Object]

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