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Stich ii trial for supratentorial intra cerebral bleed


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supratentorial intracerebral h'age

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Stich ii trial for supratentorial intra cerebral bleed

  1. 1. Dr. Gaurav Kumar Emergency Medicine Resident Aiims 9/27/2014 1
  2. 2. Background STICH –pontaneous supratentorial lobar intracerebral haematomas. 9/27/2014 2
  3. 3. Background Spontaneous intracerebral haemorrhage (ICH) accounts for 10 to 40% of all cases of stroke The morbidity and mortality exceed 60%. Young disabled survivors are a significant burden to both Health Services and family. 9/27/2014 3
  4. 4. Background Within the spectrum of spontaneous intracerebral haemorrhage there are some patients with large or space occupying haemorrhage who require surgery for neurological deterioration .  And others with small haematomas who should be managed conservatively. There is equipoise about the management of patients between these two extremes. 9/27/2014 4
  5. 5. Findings of previous trials The first randomised trial of Surgical Treatment of ICH, published in 1961. But it did not show a significant advantage for either surgical or conservative treatment. Many other studies were done after this but none showed benefit of one over other method of Rx. 9/27/2014 5
  6. 6. STICH I The need to gain evidence to support clinical decision making led to the initiation of the Surgical Trial in Intracerebral Haemorrhage (STICH). Started in 1998, this trial is the largest to date and successfully recruited 1033 patients from 87 centres around the world. 9/27/2014 6
  7. 7. RESULT OF STICH I  Showed a small non-significant advantage for surgery (Mendelow et al. 2005) 9/27/2014 7
  8. 8. UNFORTUNATE OUTCOME OF STICH I Had been that many people misinterpreted the results to argue that there was no need to operate on patients with ICH at all ! 9/27/2014 8
  9. 9. Neurosurgeons know that early removal of an intracranial haemorrhage is highly effective in the context of trauma.  It seems unlikely that surgery would be of benefit in one scenario and not in the other. Hence the STICH II Trial. 9/27/2014 9
  10. 10. TRIAL DESIGN Prospective, randomized, parallel group trial. In all, 129 NSx units in 39 countries.  Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible for the trial.  Outcome is measured at six months via a postal questionnaire 9/27/2014 10
  11. 11. INCLUSION CRITERIA All of the following :  Evidence of a spontaneous lobar ICH on CT scan (1 cm or less from the cortex surface of the brain) Patient within 48 hours of ictus.  Best MOTOR score on the Glasgow Coma Scale (GCS) of 5 or 6 and best EYE score on the GCS of 2 or more Volume of haematoma between 10 and 100 ml [Calculated using (a × b × c)/2 method]. 9/27/2014 11
  12. 12. Eligible CT 9/27/2014 12
  13. 13. EXCLUSION CRITERIA Any of them : Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation. Intraventricular haemorrhage of any sort. ICH secondary to tumour or trauma. 9/27/2014 13
  14. 14. Not CT 9/27/2014 14
  15. 15. EXCLUSION CRITERIA Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions If surgery cannot be performed within 12 hours.  Patients who did not consent to participate 9/27/2014 15
  16. 16. INTERVENTIONS  Patients were randomly allocated to either early surgery or initial conservative treatment. All patient must have an baseline CT head. In the early surgery group, surgeons were expected to undertake evacuation of the haematomas within 12 h.  In the initial conservative treatment group, delayed evacuation was permitted if judged clinically appropriate. 9/27/2014 16
  17. 17. RANDOMIZATION It is not possible to blind either patients or treating surgeons to when the patient has had surgery or whether they have had surgery. To minimise possible sources of bias randomisation is undertaken centrally by an independent organization. Centre for Healthcare Randomised Trials, Aberdeen. 9/27/2014 17
  18. 18. RANDOMIZATION Randomisation must take place within 48 hours of ictus Eligible patients randomly assigned in a 1:1 ratio to early surgery or early medical treatment group. Randomization done with the use of telephone and internet based system with stratification according to country and planned operation. 9/27/2014 18
  19. 19. STUDY END POINTS Primary end point :  DEATH. Severe disability. 9/27/2014 19
  20. 20. STUDY END POINTS Secondary end point : mortality,  time to death, prognosis-based dichotomised Rankin and GOSE, and Rankin and EuroQol; all measured at 6 months. 9/27/2014 20
  21. 21. Statistical analysis  Analysis will be on an “intention to treat” basis  a sample size of 566 (283 in each group) was needed to show a 12% benefit from surgery (two-sided significance level of 0·05) with 80% power. Hence a sample size of 600 patients to allow for withdrawals and crossovers. 9/27/2014 21
  22. 22. Statistical analysis Primary outcome analysis was a simple categorical frequency comparison by use of the χ2 test for prognosis-based favourable and unfavourable outcome on GOSE(GLASGOW OUTCOME SCALE-EXTENDED) Secondary analysis consisted of a Kaplan-Meier survival curve with log-rank test, χ2 test for mortality at 6 months, and 6 month prognosis-based Rankin 9/27/2014 22
  23. 23. RESULTS 9/27/2014 23
  24. 24. No. of patients in study=601 294 307 no. of patients conervaticve gp. surgery gp. 9/27/2014 24
  26. 26. The two groups were well matched at baseline, 57% of total were male and median age was 65. 50% of patient in early surgery group and 49% in early conservative group had a GCS of 14 or 15 at the time of randomization. 9/27/2014 26
  27. 27. Characteristics of haematomas EARLY SURGERY GROUP CONSERVATIVE GROUP VOLUME(ML) MEDIAN 38 36 MEAN 41.4 41.0 DEPTH(MM) MEDIAN 1 1 MEAN 1.6 1.6 SIDE OF H’AGE LEFT 158 (52%) 149 (51%) RIGHT 147 (48%) 142 (49%) 9/27/2014 27
  28. 28. outcome Early surgery group Early conservative group 9/27/2014 28 Primary outcome Prognosis based Unfavourable 174(59%) 178(62%) Favourable 123(41%) 108(38%) Secondary outcome Mortality at 6 months Dead 54(18%) 69(24%) Alive 244(82%) 222(76%) Prognosis based modified Rankin Unfavourable 155 (53%) 158 (56%) Favourable 140 (47%) 126 (43%)
  30. 30. KAPLAN-MEIER SURVIVAL CURVE Source: The Lancet 2013; 382:397-408 (DOI:10.1016/S0140-6736(13)60986-1)
  31. 31. Discussion  DID not find significant evidence to support that early surgery compared with initial conservative treatment (with delayed surgery if the patient deteriorates) improves outcome in conscious patients in whom there is a superficial intracerebral haemorrhage of 10—100 mL and no evidence of intraventricular haemorrhage. 9/27/2014 31
  32. 32. Strengths of the study Prospective randomized trial. Baseline characteristics of patients similar. Early randomization and early surgery. 9/27/2014 32
  33. 33. Limitations of the study Cross over : 62 (21%) of 291 patients assigned to initial conservative treatment went on to have delayed surgery.But because of the intention-to-treat analysis they remained in the initial conservative treatment group. 9/27/2014 33
  34. 34. Limitations of the study More than half of the patients had good prognosis(i.e. 66% pt inearly surgery group and 64% pt inconsevative group) But the patients who benefited most from surgery were poor prognosis group. 9/27/2014 34
  35. 35. Critical Appraisal Was the randomization list concealed ? yes Was the follow up of the patients sufficiently long and complete ? yes Were the patients, clinicians and the study personnel kept “blind” to treatment ? No Were the groups treated equally ? yes Were the groups similar at the start of the trial ? yes Does these results apply to our patient ? ? 9/27/2014 35