Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH

Not Applicable

• Conditions: Intracranial Hemorrhages
• Interventions: Procedure: non-Decompressive Craniectomy; Procedure: Decompressive Craniectomy

• Registration Number: NCT02135783
• Lead Sponsor: Southwest Hospital, China

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Study Start: 2014-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05
• Primary Completion: 2017-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mortality and disability	3 months	according to a 3-6 scores on the modified Rankin Score

Secondary Outcome Measures

Name	Time	Method
Occurrence of second Surgery	72 hours

Trial Locations

Locations (1)

Department of Neurosurgery , Southwest Hospital, Third Military Medical University,; 🇨🇳 Chongqing, China