Decompressive Craniectomy in Patients With Cerebellar Infarction

NCT ID: NCT05670249

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-05
• Study Completion Date: 2021-04-30

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.

Conditions

Cerebellar Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

suboccipital decompressive craniectomy

Intervention Type: PROCEDURE

extensive bilateral suboccipital decompressive craniectomy with duraplasty

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

suboccipital decompressive craniectomy

extensive bilateral suboccipital decompressive craniectomy with duraplasty

Intervention Type: PROCEDURE

Other Intervention Names

space occupying surgey

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Emre Kumral

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EU0691

Identifier Type: -

Identifier Source: org_study_id