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STITCH (TRAUMA)

Surgical Trial In Traumatic intraCerebral Haemorrhage

Specialty
InjuriesEmergencies
Portfolio Eligibility
Automatically eligible
ISRCTN 19321911
EudraCT
MREC N° 09/H0502/68
UKCRN ID 7904
WHO ID
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
  20%
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

University of Newcastle upon Tyne
Neurosurgical Trials Unit
3-4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
UNITED KINGDOM

Tel: 0191 208 5793
Fax: 0191 208 5762
barbara.gregson@ncl.ac.uk
Funder(s) National Insititue for Health Research -
Sponsor(s) Newcastle upon Tyne Hospitals NHS Foundation Trust




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