Surgical Trial in Lobar Intracerebral Haemorrhage
This trial is active, not recruiting.
|Sponsor||Taipei Medical University WanFang Hospital|
|Start date||August 2010|
|End date||April 2011|
|Trial size||600 participants|
|Trial identifier||NCT01320423, 99073|
To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH will improve outcome compared to a policy of initial conservative treatment. The trial will also help to better define the indications for early surgery.
This will overcome two of the criticisms of STICH (timing was too late and sometimes location was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis identified for STICH II is in line with current neurosurgical opinion.
|Intervention model||parallel assignment|
Glasgow Outcome Scale/ Modified Rankin Scale
time frame: six months
Male or female participants at least 20 years old.
Inclusion Criteria: - 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 GCS of 5 or 6 and best EYE score on the GCS of 2 or more. - Volume of haematoma between 10 and 100ml [Calculated using (a x b x c)/2 method] Exclusion Criteria: - 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. - Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions. - Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome. - If surgery cannot be performed within 12 hours. - If the haematological effects of any previous anticoagulants are not completely reversed.
|Official title||Surgical Trial in Lobar Intracerebral Haemorrhage|
|Principal investigator||Wen-Ta Chiu|
|Description||STICH II is an international multicentre randomised parallel group trial comparing early craniotomy to evacuate the haematoma with initial conservative treatment, following spontaneous superficial intracerebral haemorrhage affecting the lobar region only. 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 including the Glasgow Outcome scale, Modified Rankin Scale, EuroQol and Barthel. Six hundred patients will be recruited to the trial over thirty months. Follow-up will take six months with analysis and reporting taking one year.|
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