Clinical Trial: Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Southwest Hospital, China

Current Primary Outcome: Mortality and disability [ Time Frame: 3 months ]

according to a 3-6 scores on the modified Rankin Score


Original Primary Outcome: Same as current

Current Secondary Outcome: Occurrence of second Surgery [ Time Frame: 72 hours ]

Original Secondary Outcome: Same as current

Information By: Southwest Hospital, China

Dates:
Date Received: May 7, 2014
Date Started: October 2014
Date Completion: October 2018
Last Updated: February 4, 2016
Last Verified: February 2016