Intracerebral HaemorrhageNCT01320423
Surgical Trial in Lobar Intracerebral Haemorrhage
A study testing Surgical Trial in people with Intracerebral Haemorrhage, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intracerebral Haemorrhage
- What is being tested?
- Surgical Trial
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a spontaneous lobar ICH on CT scan (1 cm or less from the cortex surface of the brain)
- Patient within 48 hours of ictus
- Best MOTOR score on the GCS of 5 or 6 and best EYE score on the GCS of 2 or more.
- Volume of haematoma between 10 and 100ml [Calculated using (a x b x c)/2 method]
Who cannot join
- Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
- Intraventricular haemorrhage of any sort
- ICH secondary to tumour or trauma.
- Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions.
- Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome.
- If surgery cannot be performed within 12 hours.
- If the haematological effects of any previous anticoagulants are not completely reversed.
Trial locations and contacts
1 site in 1 country.
About this study
To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar 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.
This will overcome two of the criticisms of STICH (timing was too late and sometimes location was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis identified for STICH II is in line with current neurosurgical opinion.
Read the detailed description
STICH II is an international multicentre randomised parallel group trial comparing early craniotomy to evacuate the haematoma with initial conservative treatment, following spontaneous superficial intracerebral haemorrhage affecting the lobar region only. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible for the trial. Outcome is measured at six months via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, EuroQol and Barthel. Six hundred patients will be recruited to the trial over thirty months. Follow-up will take six months with analysis and reporting taking one year.
- Conditions
- Intracerebral Haemorrhage
- Being tested
- Surgical Trial
- Keywords
- Intracerebral Haemorrhage
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical TrialProcedure or surgery
Surgical Trial in Lobar Intracerebral Haemorrhage
| Study group | Role | What they receive |
|---|---|---|
| surgery | Other | Not described Receives: Procedure: Surgical Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale/ Modified Rankin Scale
Unfavourable outcome will be death or severe disability which will be defined using a prognosis based 8 point Glasgow Outcome Scale/ Modified Rankin Scale
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionApr 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wen-Ta Chiu, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320423
- Sponsor's protocol ID
- 99073
- Status last verified
- Mar 2011
- First submitted
- 18 Mar 2011
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Trial in Lobar Intracerebral Haemorrhage
- ClinicalTrials.gov ID
- NCT01320423
- Acronym / sponsor ID
- 99073
- Conditions
- Intracerebral Haemorrhage
- Keywords
- Intracerebral Haemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar 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.
This will overcome two of the criticisms of STICH (timing was too late and sometimes location was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis identified for STICH II is in line with current neurosurgical opinion.
Detailed description
STICH II is an international multicentre randomised parallel group trial comparing early craniotomy to evacuate the haematoma with initial conservative treatment, following spontaneous superficial intracerebral haemorrhage affecting the lobar region only. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible for the trial. Outcome is measured at six months via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, EuroQol and Barthel. Six hundred patients will be recruited to the trial over thirty months. Follow-up will take six months with analysis and reporting taking one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | Other | Procedure: Surgical Trial |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Evidence of a spontaneous lobar ICH on CT scan (1 cm or less from the cortex surface of the brain)
- Patient within 48 hours of ictus
- Best MOTOR score on the GCS of 5 or 6 and best EYE score on the GCS of 2 or more.
- Volume of haematoma between 10 and 100ml [Calculated using (a x b x c)/2 method]
Key exclusion criteria (7 listed)
- Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
- Intraventricular haemorrhage of any sort
- ICH secondary to tumour or trauma.
- Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions.
- Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical TrialSurgical Trial in Lobar Intracerebral Haemorrhage | Procedure or surgery | surgery |
Primary outcome
Glasgow Outcome Scale/ Modified Rankin Scale
Time frame: six months
Unfavourable outcome will be death or severe disability which will be defined using a prognosis based 8 point Glasgow Outcome Scale/ Modified Rankin Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Ta Chiu principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Trial in people with Intracerebral Haemorrhage, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale/ Modified Rankin Scale (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2011.