Cerebellar StrokeDEMCINCT05670249
Decompressive Craniectomy in Patients With Cerebellar Infarction
A study testing suboccipital decompressive craniectomy in people with Cerebellar Stroke, run by Ege University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cerebellar Stroke
- What is being tested?
- suboccipital decompressive craniectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2016to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Decompressive Craniectomy In Patients With Malignant Cerebellar Infarction: A Randomized, Controlled Trial in a Turkish Population (DEMCI Trial)
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.
Read the 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.
- Conditions
- Cerebellar Stroke
- Being tested
- suboccipital decompressive craniectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suboccipital decompressive craniectomyProcedure or surgery
Also called space occupying surgey
extensive bilateral suboccipital decompressive craniectomy with duraplasty
| Study group | Role | What they receive |
|---|---|---|
| surgical plus medical treatment | Active comparator | 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. Receives: Procedure: suboccipital decompressive craniectomy |
| conservative medical treatment | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: one year
Secondary outcomes (3)
Death
Patient who died due to surgery
Measured: 1 year
Barthel Index,
Barthel index which ranges from 0 [dependent] to 100 [Totally independent)
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start5 Jan 2016
- Primary completion25 Dec 2019
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Emre Kumral, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670249
- Sponsor's protocol ID
- EU0691
- Acronym
- DEMCI
- Status last verified
- Jan 2023
- First submitted
- 20 Nov 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to Share IPD is 'Yes"
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompressive Craniectomy In Patients With Malignant Cerebellar Infarction: A Randomized, Controlled Trial in a Turkish Population (DEMCI Trial)
- ClinicalTrials.gov ID
- NCT05670249
- Acronym / sponsor ID
- DEMCI / EU0691
- Conditions
- Cerebellar Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 25 Dec 2019 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| surgical plus medical treatment | Active comparator | Procedure: suboccipital decompressive craniectomyDecompressive 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. |
| conservative medical treatment | No intervention | –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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suboccipital decompressive craniectomyAlso: space occupying surgeyextensive bilateral suboccipital decompressive craniectomy with duraplasty | Procedure or surgery | surgical plus medical treatment |
Primary outcome
The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score
Time frame: one year
The modified Rankin scale (mRS), which ranges from 0 [no symptoms] to 6 [death]).
3 secondary outcomes
Death
Time frame: 1 year
Barthel Index,
Time frame: 1 year
NIHSS (National Institute of Health Stroke Scale)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: Undecided. Plan to Share IPD is 'Yes"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing suboccipital decompressive craniectomy in people with Cerebellar Stroke, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.