Clinical trial NCT02135783: Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH
Official title: A Randomised Trial to Establish the Efficacy and Safety of Decompressive Craniectomy Combined With Hematoma Removal in Patients With Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Hemorrhages
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality and disability
timeFrame: 3 months
Secondary outcomes:
measure: Occurrence of second Surgery
timeFrame: 72 hours
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
Study officials:
affiliation: Department of Neurosurgery, Southwest Hospital
name: Rong Hu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu R, Zhang C, Xia J, Ge H, Zhong J, Fang X, Zou Y, Lan C, Li L, Feng H. Long-term Outcomes and Risk Factors Related to Hydrocephalus After Intracerebral Hemorrhage. Transl Stroke Res. 2021 Feb;12(1):31-38. doi: 10.1007/s12975-020-00823-y. Epub 2020 Jun 8.