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ISRCTN
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ISRCTN19976990
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DOI
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10.1186/ISRCTN19976990
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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International Surgical Trial in Intracerebral Haemorrhage
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Scientific title
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Acronym
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STICH
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Serial number at source
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G9702441
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Study hypothesis
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To determine whether a policy of early surgical evacuation of a spontaneous supratentorial intracerebral haemorrhage will improve outcome compared to a policy of initial conservative treatment. Predefined subgroup analysis will be used to better define indications for early surgery
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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International
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Disease/condition/study domain
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Neuroscience, psychiatry
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Participants - inclusion criteria
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1. Spontaneous, supratentorial intracerebral haemorrhage within 72 h and uncertainty about surgery
2. Minimum clot diameter of 2 cm on initial Computed Tomography (CT)
3. Glasgow Coma Score of 5 or above
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Participants - exclusion criteria
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1. Haemorrhage due to aneurysm or arteriovenous malformation
2. Cerebellar or brainstem haemorrhages or brainstem extensions of a supratentorial haemorrhage
3. ICH secondary to a tumour or trauma
4. Where surgery cannot be performed within 24 h of randomisation
5. Evidence of severe pre-existing physical or mental disability or of severe co-morbidity which might interfere with the assessment of outcome
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Anticipated start date
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28/02/1998
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Anticipated end date
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28/02/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1000
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Interventions
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Early surgical evacuation/initial conservative treatment
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Primary outcome measure(s)
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Glasgow Outcome Scale (favourable = GR/MD: unfavourable = SD/V/D)/ Rankin & Barthel Scale/Mortality
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15680453
1. 2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16671426
2. 2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16671427
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Contact name
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Dr
AD
Mendelow
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Address
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Professor & Head of Department of Neurosurgery
Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4AE
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Country
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United Kingdom
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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13/01/2011
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Date ISRCTN assigned
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23/10/2000
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