Decompressive Craniectomy in Patients With Cerebellar Infarction

Study Overview
=================
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.

Official Title
-----------------
Decompressive Craniectomy In Patients With Malignant Cerebellar Infarction: A Randomized, Controlled Trial in a Turkish Population (DEMCI Trial)

Conditions
-----------------
Cerebellar Stroke

Intervention / Treatment
-----------------
* Procedure: suboccipital decompressive craniectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgical plus medical treatment<br>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. | Procedure: suboccipital decompressive craniectomy<br>* extensive bilateral suboccipital decompressive craniectomy with duraplasty<br>* Other names: space occupying surgey;|
| No Intervention: conservative medical treatment<br>Control group (conservative medical) was treated equally aggressive with regard to intensive care measures. Medical management generally followed the Turkish and European guidelines on acute stroke care valid at the time of patient admission. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score | The modified Rankin scale (mRS), which ranges from 0 [no symptoms] to 6 [death]). | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Patient who died due to surgery | 1 year | 
| Barthel Index, | Barthel index which ranges from 0 [dependent] to 100 [Totally independent) | 1 year | 
| NIHSS (National Institute of Health Stroke Scale) | independent), NIHSS ranges from 0 to 42 (the higher the score, the more severe the stroke) | 1 year |