Condition category
Nervous System Diseases
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
09/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr AD Mendelow

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9702441

Study information

Scientific title

Acronym

STICH

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neuroscience, psychiatry

Intervention

Early surgical evacuation/initial conservative treatment

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Glasgow Outcome Scale (favourable = GR/MD: unfavourable = SD/V/D)/ Rankin & Barthel Scale/Mortality

Secondary outcome measures

Not provided at time of registration

Overall trial start date

28/02/1998

Overall trial end date

28/02/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

1000

Participant 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

Recruitment start date

28/02/1998

Recruitment end date

28/02/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor & Head of Department of Neurosurgery
Newcastle upon Tyne
NE2 4AE
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/15680453
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16671426
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16671427

Publication citations

  1. Results

    Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH, , Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial., Lancet, 365, 9457, 387-397, doi: 10.1016/S0140-6736(05)17826-X.

  2. Results

    Prasad KS, Gregson BA, Bhattathiri PS, Mitchell P, Mendelow AD, , The significance of crossovers after randomization in the STICH trial., Acta Neurochir. Suppl., 2006, 96, 61-64.

  3. Results

    Bhattathiri PS, Gregson B, Prasad KS, Mendelow AD, , Intraventricular hemorrhage and hydrocephalus after spontaneous intracerebral hemorrhage: results from the STICH trial., Acta Neurochir. Suppl., 2006, 96, 65-68.

Additional files

Editorial Notes