Decompressive Craniectomy in Patients With Cerebellar Infarction
- Conditions
- Cerebellar Stroke
- Interventions
- Procedure: suboccipital decompressive craniectomy
- Registration Number
- NCT05670249
- Lead Sponsor
- Ege University
- Brief Summary
The investigators aimed to evaluate the outcome in participants up to 80 years of age with space-occupying cerebellar infarction treated with suboccipital decompressive craniectomy (SDC) compared to medical therapy alone.
- Detailed Description
This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. The primary end point was survival with favorable outcome, defined as a score of 0 to 3 on the mRS at 12 months (±30 days) after randomization (defined by a score of 0 to 3 on the modified Rankin scale (mRS), which ranges from 0 \[no symptoms\] to 6 \[death\]). Secondary outcomes included death, Barthel Index, baseline stroke severity NIHSS (National Institute of Health Stroke Scale), and SF-36 at 6 months and 1-year after randomization. The variables for subgroup analysis were age, sex, time to randomization, lesion volume, brainstem involvement, hemorrhagic transformation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- The presence of cerebellar territory infarction with an NIHSS score ≥8.
- Initial Glasgow Coma Scale (GCS) score <9 on admission and clinical deterioration (a score of ≥ 1 decrease on GCS score) within 48 hours from onset.
- Decrease in the level of consciousness to a score of ≥ 1 on item 1a (level of consciousness) of the NIHSS, rapid deterioration to coma.
- Prestroke mRS score ≥2.
- Prestroke score on the Barthel Index <95.
- Score on the Glasgow Coma Scale ≤6.
- Both pupils fixed and dilated.
- Any other coincidental brain lesion that might affect outcome.
- Space-occupying hemorrhagic transformation of the infarct.
- Pregnancy.
- Life expectancy <3 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description surgical plus medical treatment suboccipital decompressive craniectomy Decompressive surgery protocol was kept constant throughout the study period and defined the following surgical interventions: (1) extensive bilateral suboccipital decompresive craniectomy with duraplasty, optional resection of the posterior arch of atlas, (2) preceding insertion of an external ventricular drainage (EVD) in all cases, and (3) evacuation of necrotic tissue.
- Primary Outcome Measures
Name Time Method The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score one year The modified Rankin scale (mRS), which ranges from 0 \[no symptoms\] to 6 \[death\]).
- Secondary Outcome Measures
Name Time Method NIHSS (National Institute of Health Stroke Scale) 1 year independent), NIHSS ranges from 0 to 42 (the higher the score, the more severe the stroke)
Barthel Index, 1 year Barthel index which ranges from 0 \[dependent\] to 100 \[Totally independent)
Death 1 year Patient who died due to surgery