Back to resultsDecompressive Craniectomy in Patients With Cerebellar Infarction (DEMCI)
Primary Purpose
Cerebellar Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
suboccipital decompressive craniectomy
Sponsored by
About this trial
This is an interventional prevention trial for Cerebellar Stroke
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
surgical plus medical treatment
conservative medical treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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]).
Secondary Outcome Measures
Death
Patient who died due to surgery
Barthel Index,
Barthel index which ranges from 0 [dependent] to 100 [Totally independent)
NIHSS (National Institute of Health Stroke Scale)
independent), NIHSS ranges from 0 to 42 (the higher the score, the more severe the stroke)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05670249
Brief Title
Decompressive Craniectomy in Patients With Cerebellar Infarction
Acronym
DEMCI
Official Title
Decompressive Craniectomy In Patients With Malignant Cerebellar Infarction: A Randomized, Controlled Trial in a Turkish Population (DEMCI Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2016 (Actual)
Primary Completion Date
December 25, 2019 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care Provider
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
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgical plus medical treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conservative medical treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
suboccipital decompressive craniectomy
Other Intervention Name(s)
space occupying surgey
Intervention Description
extensive bilateral suboccipital decompressive craniectomy with duraplasty
Primary Outcome Measure Information:
Title
The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score
Description
The modified Rankin scale (mRS), which ranges from 0 [no symptoms] to 6 [death]).
Time Frame
one year
Secondary Outcome Measure Information:
Title
Death
Description
Patient who died due to surgery
Time Frame
1 year
Title
Barthel Index,
Description
Barthel index which ranges from 0 [dependent] to 100 [Totally independent)
Time Frame
1 year
Title
NIHSS (National Institute of Health Stroke Scale)
Description
independent), NIHSS ranges from 0 to 42 (the higher the score, the more severe the stroke)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Plan to Share IPD is 'Yes"
Learn more about this trial
Decompressive Craniectomy in Patients With Cerebellar Infarction
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