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 range

20 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Intracerebral Haemorrhage trials