Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH (CARICH)

Army Medical University

Status: Unknown

Conditions: Intracranial Hemorrhages

Treatments: Procedure: Decompressive Craniectomy; Procedure: non-Decompressive Craniectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02135783

Neurosurg 01

Details and patient eligibility

About

Decompressive craniectomy has been reported for the treatment of patients with intracerebral hemorrhage. But no prospective randomised controlled trials have yet been undertaken to confirm its effect.The purpose of the study is to determine whether decompressive craniectomy post hematoma removal surgery after intracerebral hemorrhage will reduce the chances of a person dying or surviving with a long term disability.

Full description

Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Hematoma removal (HR) surgery is the primary treatment for ICH which volume is more than 30ml. But whether decompressive craniectomy (DC) should be employed during the HR surgery still has considerable controversy. Outcomes in this study will be measured at 3 months after surgery via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, and Barthel index. Two hundred patients will be recruited to the trial over 36 months. Follow-up will take three months with analysis and reporting taking one year.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of a spontaneous lobar and basal ganglia ICH on CT scan
• Patient within 72 hours of ictus
• Best score on the GCS of 5-13.
• Volume of hematoma between 30 and 100ml [Calculated using (a x b x c)/2 method]
• The history of hypertensive

Exclusion criteria

• Clear evidence that the hemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
• Intraventricular hemorrhage of any sort
• ICH secondary to tumour or trauma.
• If the hematological effects of any previous anticoagulants are not completely reversed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Decompressive Craniectomy

Experimental group

Description:

Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage

Treatment:

Procedure: Decompressive Craniectomy

non-Decompressive Craniectomy

Active Comparator group

Description:

non-Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage

Treatment:

Procedure: non-Decompressive Craniectomy