Condition category
Injury, Occupational Diseases, Poisoning
Date applied
19/03/2009
Date assigned
27/03/2009
Last edited
09/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
-
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
-
amanda.tortice@nuth.nhs.uk

Sponsor type

Government

Website

http://www.newcastle-hospitals.org.uk/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes