Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

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: or you can email the team at

Trial website

Contact information



Primary contact

Prof A David Mendelow


Contact details

Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
United Kingdom
+44 (0)191 222 5793

Additional identifiers

EudraCT number number

Protocol/serial number

MRC G0501444/NUTH 3545

Study information

Scientific title

Surgical Trial in Lobar Intracerebral Haemorrhage



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 at:

On 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)'.

On 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.

Ethics approval

Multi-Centre Research Ethics Committee for Scotland (Committee A), 28/08/2006, REC ref: 06/MRE00/66

Study design

International multicentre randomised parallel group trial

Primary study design


Secondary study design

Randomised parallel trial

Trial setting


Trial type


Patient information sheet

A patient information sheet section is included in the protocol available at:


Spontaneous intracerebral haemorrhage confined to the lobar region


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 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 type



Drug names

Primary outcome measures

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 measures

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

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

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

Trial participating centre

Newcastle University
Newcastle upon Tyne
United Kingdom

Trial participating centre

126 hospitals around the world

Sponsor information


Newcastle upon Tyne Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation programme (EME)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

2011 protocol in:
2012 statistical analysis plan in:
2013 results in:

Publication citations

  1. Protocol

    Mendelow AD, Gregson BA, Mitchell PM, Murray GD, Rowan EN, Gholkar AR, , Surgical trial in lobar intracerebral haemorrhage (STICH II) protocol., Trials, 2011, 12, 124, doi: 10.1186/1745-6215-12-124.

  2. Statistical analysis plan

    Gregson BA, Murray GD, Mitchell PM, Rowan EN, Gholkar AR, Mendelow AD, Update on the Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II): statistical analysis plan., Trials, 2012, 13, 222, doi: 10.1186/1745-6215-13-222.

  3. Results

    Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM, , Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial., Lancet, 2013, 382, 9890, 397-408, doi: 10.1016/S0140-6736(13)60986-1.

Additional files

Editorial Notes