NCT02135783

Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Hemorrhages

Interventions

Type	Name	Description
PROCEDURE	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.
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-10-01
• Completion: 2018-10-01
• First posted: 2014-05-12
• Last updated: 2016-02-05

Locations

1 site across 1 country: China