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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.

Surgical Trial In Traumatic intraCerebral Haemorrhage

Portfolio Eligibility
Automatically eligible
ISRCTN 19321911
MREC N° 09/H0502/68
Research Summary
STITCH (Trauma) is an international multicentre trial of early surgery compared with initial conservative treatment for patients with traumatic intracerebral haemorrhage. Follow-up will occur at 3 months (UK only), 6 months and 12 months.
Study Type Interventional
Design Type Treatment
Disease(s) Injuries and Emergencies
Phase III
Current Status Closed - follow-up complete
Closure Date 9/30/2012
Global Sample Size 840
Global Recruitment to Date
Geographical Scope International Multi-Centre
Lead Country England (also active in Scotland)
Health care professionals can obtain a copy of the protocol by clicking here
Study Website
Main Inclusion Criteria
• Adults aged 14 or over
• Evidence of a TICH on CT with a confluent volume of attenuation significantly raised above that of the background white
and grey matter that has a total volume greater than 10mls calculated by (width x height x length in cm)/ 2.
• Within 24 hours of head injury.
• Clinical equipoise: only patients for whom the responsible neurosurgeon is uncertain about the benefits of either
treatment are eligible.
Main Exclusion Criteria
• A significant surface haematoma (EDH or SDH) requiring surgery. (The indications for intervention for these patients are
already very well defined.)
• 3 or more separate haematomas fulfilling inclusion criteria
• If surgery can not be performed within 12 hours of randomisation.
• Severe pre−existing physical or mental disability or severe co−morbidity which would lead to a poor outcome even if the
patient made a full recovery from the head injury (Examples would be a high level of dependence before the injury or
severe irreversible associated injury such as complete spinal cord injury).
• Permanent residence outside a study country preventing follow up.
• Patient and/or relative has a strong preference for one treatment modality.
Chief Investigator(s)
Prof David Mendelow
Further details, please contact
Dr Barbara Gregson

Newcastle University
Neurosurgical Trials Unit
3-4 Claremont Terrace
Newcastle University
Newcastle upon Tyne

Tel: 0191 208 5793
Fax: 0191 208 5762
Funder(s) NIHR
Sponsor(s) Newcastle upon Tyne Hospitals NHS Foundation Trust
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