Surgical Trial In Traumatic intraCerebral Haemorrhage

ISRCTN ISRCTN19321911
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

Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom

Email trauma.stitch@ncl.ac.uk

Study information

Study designInternational multi-centre pragmatic randomised parallel-group trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSurgical Trial In Traumatic intraCerebral Haemorrhage: an international multi-centre pragmatic randomised parallel group trial
Study acronymSTITCH (Trauma)
Study objectivesA 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) studiedTraumatic intracerebral haemorrhage and contusion
InterventionEarly surgery vs initial conservative treatment
Intervention typeProcedure/Surgery
Primary outcome measureUnfavourable 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 measuresThe 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 date01/09/2009
Completion date28/02/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants840
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2009
Date of final enrolment28/02/2014

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

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
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

Email amanda.tortice@nuth.nhs.uk
Website http://www.newcastle-hospitals.org.uk/
ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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