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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN19321911 |
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Date of registration:
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27/03/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Surgical Trial In Traumatic intraCerebral Haemorrhage
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Scientific title:
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Surgical Trial In Traumatic intraCerebral Haemorrhage: an international multi-centre pragmatic randomised parallel group trial |
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Date of first enrolment:
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01/09/2009 |
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Target sample size:
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840 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN19321911 |
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Study type:
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Interventional |
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Study design:
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International multi-centre pragmatic randomised parallel-group trial (Treatment)
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Phase:
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Countries of recruitment
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Czech Republic
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Egypt
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Germany
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Greece
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India
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Italy
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Latvia
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Lithuania
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Macedonia
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Poland
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Russian Federation
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Spain
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United Kingdom
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United States of America
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Contacts
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Name:
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Barbara A
Gregson |
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Address:
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Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
NE2 4AE
Newcastle upon Tyne
United Kingdom |
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Telephone:
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- |
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Email:
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trauma.stitch@ncl.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Traumatic intracerebral haemorrhage and contusion
Injury, Occupational Diseases, Poisoning
Intracerebral haemorrhage
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Intervention(s)
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Early surgery vs initial conservative treatment
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Secondary ID(s)
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HTA 07/37/16; 1.0
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Source(s) of Monetary Support
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Health Technology Assessment Programme
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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