Surgical Trial In Traumatic intraCerebral Haemorrhage
ISRCTN | ISRCTN19321911 |
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DOI | https://doi.org/10.1186/ISRCTN19321911 |
Secondary identifying numbers | HTA 07/37/16; 1.0 |
- Submission date
- 19/03/2009
- Registration date
- 27/03/2009
- Last edited
- 09/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Barbara A Gregson
Scientific
Scientific
Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
trauma.stitch@ncl.ac.uk |
Study information
Study design | International multi-centre pragmatic randomised parallel-group trial |
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Primary study design | Interventional |
Secondary study design | Randomised parallel trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Surgical Trial In Traumatic intraCerebral Haemorrhage: an international multi-centre pragmatic randomised parallel group trial |
Study acronym | STITCH (Trauma) |
Study objectives | 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.nets.nihr.ac.uk/projects/hta/073716 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. |
Ethics approval(s) | Submission pending as of 19/03/2009 |
Health condition(s) or problem(s) studied | Traumatic intracerebral haemorrhage and contusion |
Intervention | Early surgery vs initial conservative treatment |
Intervention type | Procedure/Surgery |
Primary outcome measure | 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 measures | 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 |
Overall study start date | 01/09/2009 |
Completion date | 28/02/2014 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 840 |
Key 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 |
Key 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 |
Date of first enrolment | 01/09/2009 |
Date of final enrolment | 28/02/2014 |
Locations
Countries of recruitment
- Czech Republic
- Egypt
- England
- Germany
- Greece
- India
- Italy
- Latvia
- Lithuania
- North Macedonia
- Poland
- Russian Federation
- Spain
- United Kingdom
- United States of America
Study participating centre
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
NE2 4AE
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Joint Research Office
R&D Department
4th Floor, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
amanda.tortice@nuth.nhs.uk | |
Website | http://www.newcastle-hospitals.org.uk/ |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 16/10/2012 | Yes | No | |
Results article | results | 01/09/2015 | Yes | No | |
Results article | results | 01/09/2015 | Yes | No |