ISRCTN ISRCTN22153967
DOI https://doi.org/10.1186/ISRCTN22153967
Secondary identifying numbers MRC G0501444/NUTH 3545
Submission date
31/03/2006
Registration date
11/10/2006
Last edited
10/05/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
STICH II is a study for patients with a type of stroke which causes bleeding into the brain (spontaneous intracerebral haemorrhage) where the bleed is close to the surface of the brain and between 10-100 ml in size. STICH II will examine whether it is better to give these patients an early operation (early surgery) or to monitor them carefully (initial conservative treatment) with an option to operate later on if necessary.

Who can participate?
This study is for adult patients who have had a CT scan confirming that they have a bleed in their brain. The study is for patients who in the opinion of the neurosurgeon could benefit equally from early surgery or initial conservative treatment.

What does the study involve?
Patients will be randomly put into either the 'early surgery' group or the 'initial conservative' group, decided by a computer system. Those who are in the 'early surgery' group will have an operation to remove the bleed in the brain within 12 hours. Those in the 'initial conservative treatment' group will be monitored closely and if necessary, receive an operation later on. Patients will have another CT scan done 5 days later. The doctor will complete a form at 2 weeks/discharge. The patient will be sent a postal questionnaire at 6 months to fill in and return.

What are the possible benefits and risks of participating?
The usual possible risks associated with having an operation or being managed 'conservatively' apply to this study. We cannot promise that the study will help the patients taking part, but the information we get might improve treatment of future patients with brain haemorrhage.

Where is the study run from?
This international study is co-ordinated by Newcastle University, Newcastle upon Tyne, UK. This study has 126 hospitals around the world taking part, from 39 countries.

When is the study starting and how long is it expected to run for?
The STICH II trial opened for recruitment in January 2007; it will finish when 600 patients have been recruited and their 6-month follow-up is complete. Publication of the results is planned in 2013.

Who is funding the study?
The trial was funded by the Medical Research Council (MRC) and funding has now been transferred to the NIHR EME programme (UK).

Who is the main contact?
The main contact is the team at the co-ordinating centre here in Newcastle. Their contact details can be found on our website at: http://research.ncl.ac.uk/stich/ or you can email the team at stich@ncl.ac.uk

Study website

Contact information

Prof A David Mendelow
Scientific

Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom

Phone +44 (0)191 222 5793
Email stich@ncl.ac.uk

Study information

Study designInternational multicentre randomised parallel group trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet A patient information sheet section is included in the protocol available at: http://www.ncl.ac.uk/stich/
Scientific titleSurgical Trial in Lobar Intracerebral Haemorrhage
Study acronymSTICH II
Study hypothesisTo 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 at: http://research.ncl.ac.uk/stich/
Ethics approval(s)Multi-Centre Research Ethics Committee for Scotland (Committee A), 28/08/2006, REC ref: 06/MRE00/66
ConditionSpontaneous intracerebral haemorrhage confined to the lobar region
InterventionThe 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). The aim is 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 5 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.
Intervention typeMixed
Primary outcome measureUnfavourable 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 measures1. Mortality
2. Modified Rankin Scale
3. Barthel's Index of Activities of daily living (BAI)
4. EuroQol Quality of Life Health Survey
5. Survival
Overall study start date01/09/2006
Overall study end date31/03/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants600
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date01/01/2007
Recruitment end date31/03/2013

Locations

Countries of recruitment

  • Armenia
  • Australia
  • China
  • Czech Republic
  • Egypt
  • England
  • Germany
  • Greece
  • Hungary
  • India
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Nepal
  • North Macedonia
  • Pakistan
  • Poland
  • Romania
  • Russian Federation
  • Singapore
  • Spain
  • Sri Lanka
  • Türkiye
  • United Kingdom
  • United States of America

Study participating centre

Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Development Department
Clinical Research Facility
4th Floor, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom

ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Government

Efficacy and Mechanism Evaluation Programme
Government organisation / National government
Alternative name(s)
NIHR Efficacy and Mechanism Evaluation Programme, EME
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 17/05/2011 Yes No
Statistical Analysis Plan statistical analysis plan 21/11/2012 No No
Results article results 03/08/2013 Yes No
Other publications retrospective methods analysis 01/02/2018 Yes No
Other publications 10/05/2023 10/05/2023 Yes No

Editorial Notes

10/05/2023: Publication reference added.
30/01/2018: Publication reference added.
07/09/2012: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/07/2012 to 31/01/2013.
2. Argentina, Austria, Belgium, the Netherlands, Sweden, South Africa and Ukraine were removed from the countries of recruitment, and Armenia, Egypt, Mexico, Nepal, Pakistan, Romania and Sri Lanka were added.

22/09/2010: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/08/2010 to 31/07/2012.
2. The sources of funding field was changed from 'Medical Research Council (MRC) (UK) (ref: G0501444)' to 'National Institute for Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation programme (EME)'.