Surgical Trial In Traumatic intraCerebral Haemorrhage

ISRCTN	ISRCTN19321911
DOI	https://doi.org/10.1186/ISRCTN19321911
Protocol serial number	HTA 07/37/16; 1.0
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Funder	Health Technology Assessment Programme

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

Primary study design	Interventional
Study design	International multi-centre pragmatic randomised parallel-group trial
Secondary study design	Randomised parallel trial
Study type	Participant 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(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
Key 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
Completion date	28/02/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England
Czech Republic
Egypt
Germany
Greece
India
Italy
Latvia
Lithuania
North Macedonia
Poland
Russian Federation
Spain
United States of America

Study participating centre

Newcastle University

Newcastle upon Tyne
NE2 4AE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No
Results article	results	01/09/2015		Yes	No
Protocol article	protocol	16/10/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes