International Surgical Trial in IntraCerebral Haemorrhage
| ISRCTN | ISRCTN19976990 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19976990 |
| Protocol serial number | G9702441 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 09/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr AD Mendelow
Scientific
Scientific
Professor & Head of Department of Neurosurgery
Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | STICH |
| Study objectives | To determine whether a policy of early surgical evacuation of a spontaneous supratentorial intracerebral haemorrhage will improve outcome compared to a policy of initial conservative treatment. Predefined subgroup analysis will be used to better define indications for early surgery |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neuroscience, psychiatry |
| Intervention | Early surgical evacuation/initial conservative treatment |
| Intervention type | Other |
| Primary outcome measure(s) |
Glasgow Outcome Scale (favourable = GR/MD: unfavourable = SD/V/D)/ Rankin & Barthel Scale/Mortality |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 1000 |
| Key inclusion criteria | 1. Spontaneous, supratentorial intracerebral haemorrhage within 72 h and uncertainty about surgery 2. Minimum clot diameter of 2 cm on initial Computed Tomography (CT) 3. Glasgow Coma Score of 5 or above |
| Key exclusion criteria | 1. Haemorrhage due to aneurysm or arteriovenous malformation 2. Cerebellar or brainstem haemorrhages or brainstem extensions of a supratentorial haemorrhage 3. ICH secondary to a tumour or trauma 4. Where surgery cannot be performed within 24 h of randomisation 5. Evidence of severe pre-existing physical or mental disability or of severe co-morbidity which might interfere with the assessment of outcome |
| Date of first enrolment | 28/02/1998 |
| Date of final enrolment | 28/02/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Professor & Head of Department of Neurosurgery
Newcastle upon Tyne
NE2 4AE
United Kingdom
NE2 4AE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2005 | Yes | No | |
| Results article | results | 01/01/2006 | Yes | No | |
| Results article | results | 01/01/2006 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
