|
|
NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
|
|
STITCH (TRAUMA)
|
|
Surgical Trial In Traumatic intraCerebral Haemorrhage
|
|
|
Topic
|
|
Injuries & Emergencies
|
|
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
|
Suspended
|
|
Closure Date
|
3/31/2013
|
|
Global Sample Size
|
840
|
|
Global Recruitment to Date
|
 20% |
|
|
|
Geographical Scope
|
International Multi-Centre
|
|
Lead Country
|
England (also active in Scotland)
|
|
Open to new sites
|
Yes, within and outside lead country
|
|
|
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
NE2 4AE
UNITED KINGDOM
Tel: 0191 222 5793
Fax: 0191 222 5762
barbara.gregson@ncl.ac.uk
|
|
| Funder(s) |
National Insititue for Health Research -
|
| Sponsor(s) |
Newcastle upon Tyne Hospitals NHS Foundation Trust
|
|
|
|