Decompressive Craniectomy in Patients With Cerebellar Infarction (DEMCI)

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.

Study Overview

• Status: Completed
• Conditions: Cerebellar Stroke
• Intervention / Treatment: Procedure: suboccipital decompressive craniectomy

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: surgical plus medical treatment; 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; extensive bilateral suboccipital decompressive craniectomy with duraplasty; Other Names: space occupying surgey
No Intervention: conservative medical treatment; 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

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2016
• Primary Completion (Actual): December 25, 2019
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: January 1, 2023
• First Posted (Estimate): January 4, 2023

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Infarction
• Other Study ID Numbers: EU0691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Plan to Share IPD is 'Yes"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No