Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-10-31

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.

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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.

Conditions

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Intracranial Hemorrhages

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Decompressive Craniectomy

Decompressive Craniectomy afte Hematoma Removal in Patients with Intracerebral Hemorrhage

Group Type EXPERIMENTAL

Decompressive Craniectomy

Intervention Type PROCEDURE

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.

non-Decompressive Craniectomy

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

Group Type ACTIVE_COMPARATOR

non-Decompressive Craniectomy

Intervention Type PROCEDURE

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.

Interventions

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Decompressive Craniectomy

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.

Intervention Type PROCEDURE

non-Decompressive Craniectomy

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.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No