Cerebellar Stroke
Conditions
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.
Interventions
PROCEDUREsuboccipital decompressive craniectomy
extensive bilateral suboccipital decompressive craniectomy with duraplasty
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
a senior neurologist (E.K. or M.D.) who was not involved in screening, randomization, or patient care, blinded to the therapeutic arm assignment of the patient assessed the mRS (primary outcome), Barthel Index, NIHSS (National Institute of Health Stroke Scale), and SF-36 (secondary outcomes) scores
Intervention model description
Participants assigned to either conservative medical or SDC group with a 1:1 allocation assignment using a random number table by co-decision of a neurologist, neurosurgeon and statistician
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Death | 1 year | Patient who died due to surgery |
| Barthel Index, | 1 year | Barthel index which ranges from 0 \[dependent\] to 100 \[Totally independent) |
| 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) |
Outcome results
None listed