Surgical Trial in Lobar Intracerebral Haemorrhage

NCT01320423 | Unknown

• 1 other identifier: 99073
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Haemorrhage

Keywords

Intracerebral Haemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

  six months

Study Arms (1)

surgery

OTHER

Procedure: Surgical Trial

Interventions

Surgical Trial PROCEDURE

Surgical Trial in Lobar Intracerebral Haemorrhage

surgery

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[Calculated using (a x b x c)/2 method\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wen-Ta Chiu

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 22, 2011
• Study Start: August 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 22, 2011

Record last verified: 2011-03

Locations

TW (1)