Surgical trial in lobar intracerebral haemorrhage

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

http://research.ncl.ac.uk/stich/

Type

Scientific

Contact name

Prof A David Mendelow

ORCID ID

Contact details

Neurosurgical Trials Unit
Newcastle University
3-4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
+44 (0)191 222 5793
stich@ncl.ac.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Secondary identifying numbers

MRC G0501444/NUTH 3545

Scientific title

Surgical Trial in Lobar Intracerebral Haemorrhage

Acronym

STICH II

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: 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

Study design

International multicentre randomised parallel group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

A patient information sheet section is included in the protocol available at: http://www.ncl.ac.uk/stich/

Condition

Spontaneous intracerebral haemorrhage confined to the lobar region

Intervention

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). 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 type

Mixed

Primary outcome measure

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 study start date

01/09/2006

Overall study end date

31/03/2013

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Sex

Both

Target number of participants

600

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

01/01/2007

Recruitment end date

31/03/2013

Countries of recruitment

Armenia, Australia, China, Czech Republic, Egypt, England, Germany, Greece, Hungary, India, Italy, Japan, Latvia, Lithuania, North Macedonia, Malaysia, Mexico, Nepal, 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

Organisation

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
NE1 4LP
England
United Kingdom

Sponsor type

Hospital/treatment centre

Website

ROR

https://ror.org/05p40t847

Funder type

Government

Funder name

Efficacy and Mechanism Evaluation Programme

Alternative name(s)

NIHR Efficacy and Mechanism Evaluation Programme, EME

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) Intention to share

No

IPD sharing plan

Not provided at time of registration

IPD sharing plan summary

Not provided at time of registration

Study outputs