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Surgical Trial in Lobar Intracerebral Haemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01320423
First received: March 18, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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 Intervention
Intracerebral Haemorrhage
 Procedure: Surgical Trial

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Trial in Lobar Intracerebral Haemorrhage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Glasgow Outcome Scale/ Modified Rankin Scale [ Time Frame: six months ] [ Designated as safety issue: No ]
    Unfavourable outcome will be death or severe disability which will be defined using a prognosis based 8 point Glasgow Outcome Scale/ Modified Rankin Scale


Estimated Enrollment: 600
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
surgery Procedure: Surgical Trial
Surgical Trial in Lobar Intracerebral Haemorrhage

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320423

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

No publications provided

Responsible Party: Wen-Ta Chiu, Graduate Institute of Injury Prevention and Control, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01320423     History of Changes
Other Study ID Numbers: 99073
Study First Received: March 18, 2011
Last Updated: March 18, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Intracerebral Haemorrhage

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

ClinicalTrials.gov processed this record on May 21, 2013