UnknownNot Applicable

Surgical Trial in Lobar Intracerebral Haemorrhage

Taiwan600 participantsStarted 2010-08

Plain-language summary

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.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Glasgow Outcome Scale/ Modified Rankin Scale

Timeframe: six months

Trial details

NCT IDNCT01320423

SponsorTaipei Medical University WanFang Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-04