International Surgical Trial in IntraCerebral Haemorrhage

ISRCTN	ISRCTN19976990
DOI	https://doi.org/10.1186/ISRCTN19976990
Secondary identifying numbers	G9702441

Submission date: 23/10/2000
Registration date: 23/10/2000
Last edited: 09/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr AD Mendelow
Scientific

Professor & Head of Department of Neurosurgery
Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	STICH
Study objectives	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
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neuroscience, psychiatry
Intervention	Early surgical evacuation/initial conservative treatment
Intervention type	Other
Primary outcome measure	Glasgow Outcome Scale (favourable = GR/MD: unfavourable = SD/V/D)/ Rankin & Barthel Scale/Mortality
Secondary outcome measures	Not provided at time of registration
Overall study start date	28/02/1998
Completion date	28/02/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	1000
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	28/02/1998
Date of final enrolment	28/02/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Professor & Head of Department of Neurosurgery

Newcastle upon Tyne
NE2 4AE
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/01/2005	Yes	No
Results article	results	01/01/2006	Yes	No
Results article	results	01/01/2006	Yes	No