Surgical Trial in Lobar Intracerebral Haemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320423
Recruitment Status : Unknown
Verified March 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 22, 2011
Last Update Posted : March 22, 2011
Information provided by:
Taipei Medical University WanFang Hospital

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Intracerebral Haemorrhage Procedure: Surgical Trial Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Trial in Lobar Intracerebral Haemorrhage
Study Start Date : August 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
surgery Procedure: Surgical Trial
Surgical Trial in Lobar Intracerebral Haemorrhage

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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]

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01320423

Taipei Medical University
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Principal Investigator: Wen-Ta Chiu Taipei Medical University

Responsible Party: Wen-Ta Chiu, Graduate Institute of Injury Prevention and Control, Taipei Medical University Identifier: NCT01320423     History of Changes
Other Study ID Numbers: 99073
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011

Keywords provided by Taipei Medical University WanFang Hospital:
Intracerebral Haemorrhage

Additional relevant MeSH terms:
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases