Decompressive Craniectomy in Patients With Cerebellar Infarction (DEMCI)

Ege University

Status: Completed

Conditions: Cerebellar Stroke

Treatments: Procedure: suboccipital decompressive craniectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05670249

EU0691

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

surgical plus medical treatment

Active Comparator group

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.

Treatment:

Procedure: suboccipital decompressive craniectomy

conservative medical treatment

No Intervention group

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.