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02 September 2010
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| [ Print-friendly version ] |
| Surgical Trial In Traumatic intraCerebral Haemorrhage |
| ISRCTN | ISRCTN19321911 |
| ClinicalTrials.gov identifier | |
| Public title | Surgical Trial In Traumatic intraCerebral Haemorrhage |
| Scientific title | Surgical Trial In Traumatic intraCerebral Haemorrhage: an international multi-centre pragmatic randomised parallel group trial |
| Acronym | STITCH (Trauma) |
| Serial number at source | HTA 07/37/16; 1.0 |
| Study hypothesis |
A policy of early surgery in patients with traumatic intracerebral haemorrhage will improve outcome at six months compared to a policy of initial conservative treatment.
More details can be found at: http://www.hta.ac.uk/1756 |
| Ethics approval | To be submitted as of 19/03/2009 |
| Study design | International multi-centre pragmatic randomised parallel group trial |
| Countries of recruitment |
Czech Republic, Egypt, Germany, Greece, India, Italy, Latvia, Lithuania, Macedonia, Poland, Russia, Spain, United Kingdom, United States of America
As of 27/03/2009, the list of countries is not yet finalised. Other countries from Africa, Asia, Australasia, Europe, and North and South America are planned to be included. |
| Disease/condition/study domain | Traumatic intracerebral haemorrhage and contusion |
| Participants - inclusion criteria |
1. Both males and females, adults aged 14 or over
2. Evidence of a traumatic intracerebral haemorrhage (TICH) on computed tomography (CT) with a single volume of attenuation significantly raised above that of the background white and grey matter that is in total greater than 10 ml calculated by width times height times length in cm divided by 2 3. Within 24 hours of head injury 4. Clinical equipoise: only patients for whom the responsible neurosurgeon is uncertain about the benefits of either treatment are eligible |
| Participants - exclusion criteria |
1. A significant surface haematoma (epidural haematoma [EDH] or subdural haematoma [SDH]) requiring surgery (The indications for intervention for these patients are already very well defined)
2. More than two separate haematomas fulfilling inclusion criteria 3. If surgery can not be performed within 36 hours of injury or 12 hours of randomisation (whichever is the shorter) 4. Severe pre-existing physical or mental disability or severe co-morbidity which might 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) 5. Permanent residence outside a study country preventing follow up 6. Patient and/or relative has a strong preference for one treatment modality |
| Anticipated start date | 01/09/2009 |
| Anticipated end date | 28/02/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 840 |
| Interventions | Early surgery vs initial conservative treatment |
| Primary outcome measure(s) |
Unfavourable outcome will be death or severe disability which will be defined using a prognosis based 8 point Glasgow Outcome Scale.
Total duration of follow-up: 6 months |
| Secondary outcome measure(s) |
The following will be assessed at 6 and 12 months:
1. Rankin scale 2. Euroqol EQ-5D 3. Mortality 4. Survival 5. Major Adverse Events (death, pulmonary embolism or deep vein thrombosis, infection, rehaemorrhage) 6. Quality-adjusted life-years (QALYs) 7. Total health care costs 8. Social costs |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Barbara A Gregson |
| Address |
STITCH Office
Ward 31 (North Wing) Newcastle General Hospital Westgate Road |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE4 6BE |
| Country | United Kingdom |
| trauma.stitch@ncl.ac.uk | |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Address |
Joint Research Office
R&D Department 4th Floor, Leazes Wing Royal Victoria Infirmary Queen Victoria Road |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE1 4LP |
| Country | United Kingdom |
| amanda.tortice@nuth.nhs.uk | |
| Sponsor website: | http://www.newcastle-hospitals.org.uk/ |
| Date applied | 19/03/2009 |
| Last edited | 06/05/2009 |
| Date ISRCTN assigned | 27/03/2009 |
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| © 2010 ISRCTN unless otherwise stated. | |
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