Decompressive Craniectomy in Patients With Cerebellar Infarction

Not Applicable

Completed

• Conditions: Cerebellar Stroke

• Registration Number: NCT05670249
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2016-01-05
• Primary Completion: 2019-12-25
• Study Completion: 2021-04-30
• Study First Submitted: 2022-11-20
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-01
• Last Update Submitted: 2023-01-01
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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