Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomised Trial to Establish the Efficacy and Safety of Decompressive Craniectomy Combined With Hematoma Removal in Patients With Intracerebral Hemorrhage

Conditions
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Intracranial Hemorrhages

Intervention / Treatment
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* Procedure: Decompressive Craniectomy
* Procedure: non-Decompressive Craniectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decompressive Craniectomy<br>Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage | Procedure: Decompressive Craniectomy<br>* A portion of frontal,temporal, and parietal bone was removed by craniectomy and the size of decompression was about 10x12 cm2.Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical microscope.<br>|
| Active Comparator: non-Decompressive Craniectomy<br>non-Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage | Procedure: non-Decompressive Craniectomy<br>* a simple hematoma removal by osteoplastic craniotomy group (HR) or Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical neuroendoscopyand the size of decompression was about 3x2.5 cm2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality and disability | according to a 3-6 scores on the modified Rankin Score | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of second Surgery |  | 72 hours |