STICH II
Surgical trial in lobar intracerebral hemorrhage
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Status:
Ongoing. Trial began late in 2006, has 217 patients enrolled (as of October, 2009) and is expected to recruit until at least December 2009 and hopefully beyond.
Purpose:
To establish whether a policy of earlier surgical evacuation of hematomas in selected patients with spontaneous lobar ICH will improve outcome compared to a policy of initial conservative treatment.
Interventions:
Craniotomy
Craniotomy to evacuate hematoma from spontaneous lobar ICH
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Location(s):
Australia, Austria,
Canada, China,
Czech Republic,
Egypt, Georgia,
Germany, Greece,
Hungary, India,
Israel, Italy,
Latvia, Lithuania,
Macedonia, Mexico, Nepal, Netherlands,
Norway, Pakistan,
Poland, Romania,
Russia, Spain, Saudi Arabia, Turkey, UK, & USA.
Year Started:
2006
Design:
International, multicentre, randomized parallel group trial.
Inclusion Criteria
Superficial, spontaneous lobar ICH on CT scan, best motor score on the Glasgow Coma Score (GCS) of 5 or 6 and best eye score on the GCS of 2 or more, and volume of hematoma between 10 and 100m.
Exclusion Criteria
If the hemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation, is secondary to tumour or trauma or extends into the basal ganglia, thalamic, cerebellar or brain stem; also if there is any intraventricular hemorrhage or hydrocephalus or if there is severe, pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome.
Patient Involvement:
Patients randomized to the trial intervention will receive early evacuation of the hematoma, usually by craniotomy, within 12 hours of randomization combined with appropriate best medical treatment, versus the control group which will receive the best medical treatment, combined with delayed evacuation only if it becomes necessary later. All patients will also have an additional CT scan at about 5 (+/- 2) days to assess changes in the hematoma size with and without surgery.
Primary Outcome:
A structured postal questionnaire, the Glasgow Outcome Scale (GOS), Modified Rankin Scale and EuroQol; Mortality and morbidity at 6 months as measured by GOS.
Secondary Outcome:
Modified Rankin Scale and EuroQol; better define indicators for surgery.
Source of Information:
Presented at 2008 International Stroke Conference (February 2008).
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Web Links and Publications:
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This information last updated on: 10/13/2009
Reviewed on: 10/13/2009.
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