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Summary

EFFECT OF INTRAVENOUS CORTICOSTEROIDS ON DEATH WITHIN 14 DAYS IN 10,008 ADULTS WITH CLINICALLY SIGNIFICANT HEAD INJURY (MRC CRASH TRIAL):RANDOMISED PLACEBO-CONTROLLED TRIAL Dr. Hussein Ssenyonjo Resident, Neurosurgery Mulago Hospital. Summary.

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Summary

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  1. EFFECT OF INTRAVENOUS CORTICOSTEROIDS ON DEATH WITHIN 14 DAYS IN 10,008 ADULTS WITH CLINICALLY SIGNIFICANT HEAD INJURY (MRC CRASH TRIAL):RANDOMISED PLACEBO-CONTROLLED TRIALDr. Hussein SsenyonjoResident, NeurosurgeryMulago Hospital

  2. Summary • Cortical steroids have been used to treat head injuries for more than 30 years.In 1997,findings after systematic review suggested that these drugs reduce the risk of death by 1-2%.The CRASH trial- a muliticentre international collaboration aimed to confirm or refute such an effect by recruiting 20,000 patients.In May,2004, the data monitoring committee disclosed the unmasked results to the steering committee,which stopped recruitment.

  3. Patients and methods • Adults 16 yrs and above who presented within 8 hrs of injury and were noted in hospital to be having GCS of 14 and less.These were recruited if the treating doctor was uncertain whether or not to use steroids-(UNCERTANITY PRINCIPLE)

  4. Procedures • Patients randomised in one of two ways. 1.reliable telephone access 2.Local pack system • We randomly allocated patients to 48 h infusion of either methylprednisolone or placebo.Loading dose 2g over 1 h in 100mls of infusion.Maintenance dose 0.4g/h for 48h at rate of 20ml/h. • Primary outcome measures were death from any cause within 2 weeks of injury and death or disability at 6 months.

  5. Statistical analysis • Estimated risk of death allocated to placebo –15%. 2% survival difference would be clinically important so the trial size had to be large enough to detect a difference of this size.A trial of 20,000 patients would have a good chance of showing a 2% survival difference at convincing levels of significance ie >90% power to achieve p<0.01 • Precision-95%CI for overall risk and 99%CI for subgroup results • Homogenicity in treatment effects assessed within subgroups by X2 test at 5% significance level.

  6. Results • 239 hospitals from 49 countries. • 10,008 patients randomised to steroid or placebo infusion • 62 <16 years, 21 enrolled > 8h after injury, 3 stopped at request of a relative.

  7. Baseline characteristics

  8. Baseline characteristics-cont

  9. Baseline characteristics-cont

  10. Baseline characteristics-cont

  11. Baseline characteristics-cont

  12. Baseline characteristics-cont

  13. Baseline characteristics-cont • Adherence to treatment-9,848(98%) • 9,748(99%)received full loading dose. • Mortality data obtained for 9,964 patients,4,985-CS M-1.052(21%) in 2wks, 4,979-P M-893(18%) • RR of death from all causes in 2wks in CS group with placebo 1.18 • RR of death at 2wks didn’t differ by injury severity (p=0.22) or time since injury(p=0.05)

  14. Effects of CS allocation on death in 2wks,by injury severity

  15. Effects of CS allocation on death from all causes in 2 weeks by CT scan results.

  16. Comment on results • Relative Risk of death at 2wks wasn’t different in any of the 8 Ct diagnosis subgroups examined

  17. Conclusion Corticosteroids should not be used routinely to use had injury whatever the severity.

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