Contact information
Type
Scientific
Primary contact
Dr Barbara A Gregson
ORCID ID
Contact details
Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
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trauma.stitch@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 07/37/16; 1.0
Study information
Scientific title
Surgical Trial In Traumatic intraCerebral Haemorrhage: an international multi-centre pragmatic randomised parallel group trial
Acronym
STITCH (Trauma)
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.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
Submission pending as of 19/03/2009
Study design
International multi-centre pragmatic randomised parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Traumatic intracerebral haemorrhage and contusion
Intervention
Early surgery vs initial conservative treatment
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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 trial start date
01/09/2009
Overall trial end date
28/02/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
840
Participant 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
Recruitment start date
01/09/2009
Recruitment end date
28/02/2014
Locations
Countries of recruitment
Czech Republic, Egypt, Germany, Greece, India, Italy, Latvia, Lithuania, Macedonia, Poland, Russian Federation, Spain, United Kingdom, United States of America
Trial participating centre
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Joint Research Office
R&D Department
4th Floor
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
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amanda.tortice@nuth.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23072576
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25738794
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26346805
Publication citations
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Protocol
Gregson BA, Rowan EN, Mitchell PM, Unterberg A, McColl EM, Chambers IR, McNamee P, Mendelow AD, Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma)): study protocol for a randomized controlled trial., Trials, 2012, 13, 193, doi: 10.1186/1745-6215-13-193.
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Results
Mendelow AD, Gregson BA, Rowan EN, Francis R, McColl E, McNamee P, Chambers I, Unterberg AW, Boyers D, Mitchell P, Early surgery versus initial conservative treatment in patients with traumatic intracerebral haemorrhage [STITCH(Trauma)]: the first randomised trial, J Neurotrauma, 2015.
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Results
Gregson BA, Rowan EN, Francis R, McNamee P, Boyers D, Mitchell P, McColl E, Chambers IR, Unterberg A, Mendelow AD, Surgical Trial In Traumatic intraCerebral Haemorrhage (STITCH): a randomised controlled trial of Early Surgery compared with Initial Conservative Treatment, Health Technol Assess, 2015, 19, 70, 1-138, doi: 10.3310/hta19700.