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Results of the CONTROL Trial: Efficacy and Safety of Recombinant Activated Factor VII in the Management of Refractory Traumatic Hemorrhage ( J Trauma.  2010;69:489–500)
Background ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Objectives ,[object Object]
Methods ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Eligibility ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Randomisation ,[object Object],[object Object],[object Object],[object Object]
Trial schematic
Endpoints ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Statistical Analysis ,[object Object],[object Object],[object Object],[object Object]
Statistical Analysis cont ,[object Object],[object Object],[object Object],[object Object]
Statistical Analysis cont ,[object Object]
What is a noninferiority test?
Subject disposition
Demographics and baseline characteristics ITT population
Clinical outcomes 30 day ITT analysis
Transfusion requirements ITT population
AEs through day 90 Safety population
Results ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Post-hoc questions ,[object Object],[object Object],[object Object]
Did rFVIIa reduce the need for blood products in bleeding trauma patients?
Did rFVIIa reduce the need for blood products in bleeding trauma patients? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Did rFVIIa reduce the need for blood products in bleeding trauma patients? ,[object Object],[object Object],[object Object],[object Object],[object Object]
What about adjusting for multiple hypothesis testing? ,[object Object]
What about adjusting for multiple hypothesis testing? ,[object Object],[object Object]
Is rFVIIa safe?
Is rFVIIa safe? ,[object Object]
Is rFVIIa safe? ,[object Object],[object Object]
Absence of evidence is not evidence of absence ,[object Object],[object Object]
In the aggregate, does rFVIIa help patients?
In the aggregate, does rFVIIa help patients? ,[object Object]
Why was the mortality rate so much lower than expected? ,[object Object],[object Object],[object Object]
PICO ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
1a. R- Was the assignment of patients to treatments  randomised ?
1b. R- Were the groups  similar  at the start of the trial?
2a. A – Aside from the allocated treatment, were groups treated equally?
2b. A – Were all patients who entered the trial accounted for? – and were they analysed in the groups to which they were randomised?
3. M - Were measures  objective  or were the patients and clinicians kept “ blind ” to which treatment was being received?
How large was the treatment effect?
How precise was the estimate of the treatment effect?
Will the results help me in caring for my patient? (ExternalValidity/Applicability) ,[object Object],[object Object],[object Object],[object Object]
Criticisms ,[object Object],[object Object],[object Object],[object Object],[object Object]
Bottom line ,[object Object],[object Object]

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