Malignant middle cerebral artery (MCA) infarction (massive hemispheric cerebral infarction)
Conditions
Interventions
Surgical Group:Decompressive hemicraniotomy plus standard medical treatment
Medical Group:standard medical treatment
Sponsors
Xuanwu Hospital of the Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) age between 18 and 80 years old; (2) inclusion within 43 hours of stroke onset; (3) able to start surgery within 5 hours after randomization; (4) decrease in consciousness to an eye and motor score of <=9 on the Glasgow coma scale (GCS); (5) ischemic signs on subsequent cerebral computed tomography (CCT) involving at least 2/3 of the MCA territory with or without additional infarction in the territory of the anterior or posterior cerebral artery (ACA/PCA) on the same side and the development of space-occupying edema (e.g., compression of the ipsilateral ventricle or displacement of midline structures); (6) written, informed consent given by the closest ralatives of patients.
Exclusion criteria
Exclusion criteria: (1) prestroke score on the modified Rankin Scale (mRS)>2; (2) diminished consciousness due to other causes such as metabolic disturbances or medication, rather than to the formation of space-occupying edema; (3) a GCS score without the verbal response item <6; (4) a dilated and fixed pupil ipsilateral to the infarct side; (5) a concomitant contralateral infarction or a secondary space-occupying hemorrhage in the area of infarction; (6) any other coincidental brain lesion or serious illness that might affect outcome; (7) life expectancy less than 3 year; (8) contraindications for anaesthesia or surgery, including known coagulopathy, systemic bleeding disorder, or pregnancy, etc..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the modified Rankin Scale (mRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality; | — |
Countries
China
Contacts
Public ContactYingying Su
Outcome results
None listed