|
ISRCTN
|
ISRCTN22153967
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Surgical Trial in Lobar Intracerebral Haemorrhage
|
|
Scientific title
|
|
|
Acronym
|
STICH II
|
|
Serial number at source
|
MRC G0501444/NUTH 3545
|
|
Study hypothesis
|
To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar IntraCerebral Haemorrhage (ICH) will improve outcome compared to a policy of initial conservative treatment. The trial will also help to better define the indications for early surgery.
The protocol can be found on http://www.ncl.ac.uk/stich/
|
|
Ethics approval
|
Multi-Centre Research Ethics Committee for Scotland (Committee A) (REC Reference: 06/MRE00/66), the committee met on August 22 2006, and the approval letter was issued on 28 August 2006.
|
|
Study design
|
International multicentre randomised parallel group trial
|
|
Countries of recruitment
|
Argentina, Australia, Austria, Belgium, China, Czech Republic, Germany, Greece, Hungary, India, Italy, Japan, Latvia, Lithuania, Macedonia, Malaysia, Netherlands, Poland, Russia, Singapore, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States of America
|
|
Disease/condition/study domain
|
Spontaneous intracerebral haemorrhage confined to the lobar region
|
|
Participants - inclusion criteria
|
1. Evidence of a spontaneous lobar ICH on Computed Tomography (CT) scan (within 1 cm of the cortical surface)
2. Patient within 48 hours of ictus
3. The 'clinical uncertainty principle' is used: only patients for whom the responsible neurosurgeon is uncertain about the benefits of either treatment are eligible. These include patients with a haematoma volume of between 10 and 100 ml and a best motor score on the Glasgow Coma Score (GCS) of five or six together with some eye opening
|
|
Participants - exclusion criteria
|
1. Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation
2. Intraventricular haemorrhage of any sort
3. ICH secondary to tumour or trauma
4. Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions
5. Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome
6. If surgery cannot be performed within 12 hours
|
|
Anticipated start date
|
01/09/2006
|
|
Anticipated end date
|
30/08/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
A patient information sheet section is included in the protocol available on http://www.ncl.ac.uk/stich/
|
|
Target number of participants
|
600
|
|
Interventions
|
The trial intervention is early evacuation of the haematoma by craniotomy, combined with appropriate best medical treatment versus best medical treatment, combined with delayed evacuation only if it becomes necessary later.
In the STICH trial, 26% of patients crossed over from conservative treatment to surgery but we have little information about the reasons for crossover. This is a major problem with surgical trials and crossovers of this size are common (Fairbank et al 2005). We aim to have fewer crossovers in STICH II. We will collect further information about the status (GCS and focal signs) of all patients through the first five days of their trial progress in order to be able to monitor the change in status that leads to a change in equipoise for the treating neurosurgeon.
|
|
Primary outcome measure(s)
|
Unfavourable outcome will be death or severe disability which will be defined using a prognosis based eight point Glasgow Outcome Scale/Modified Rankin Scale (Mendelow et al 2003, 2005).
|
|
Secondary outcome measure(s)
|
1. Mortality
2. Modified Rankin Scale
3. Barthel's Index of Activities of daily living (BAI)
4. EuroQol Quality of Life Health Survey
5. Survival
|
|
Sources of funding
|
Medical Research Council (MRC) (UK) (ref: G0501444)
|
|
Trial website
|
http://www.ncl.ac.uk/stich
|
|
Publications
|
|
|
Contact name
|
Prof
A David
Mendelow
|
|
Address
|
Department of Neurosurgery
Directorate of Neurosciences
Newcastle General Hospital
Westgate Road
|
|
City/town
|
Newcastle upon Tyne
|
|
Zip/Postcode
|
NE4 6BE
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)191 2563151
|
|
Fax
|
+44 (0)191 256 3268
|
|
Email
|
stich@ncl.ac.uk
|
|
Sponsor
|
Newcastle upon Tyne Hospitals NHS Trust (UK)
|
|
Address
|
Research and Development Department
Clinical Research Facility
4th Floor, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
|
|
City/town
|
Newcastle upon Tyne
|
|
Zip/Postcode
|
NE1 4LP
|
|
Country
|
United Kingdom
|
|
Date applied
|
31/03/2006
|
|
Last edited
|
23/07/2009
|
|
Date ISRCTN assigned
|
11/10/2006
|
