Decompressive Craniectomy in Patients With Cerebellar Infarction

NCT05670249 | Completed DMC

• 1 other identifier: EU0691
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebellar Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Death

  1 year

• Barthel Index,

  1 year

• NIHSS (National Institute of Health Stroke Scale)

  1 year

Study Arms (2)

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.

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.

Interventions

suboccipital decompressive craniectomy PROCEDURE

extensive bilateral suboccipital decompressive craniectomy with duraplasty

Also known as: space occupying surgey

surgical plus medical treatment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: a senior neurologist (E.K. or M.D.) who was not involved in screening, randomization, or patient care, blinded to the therapeutic arm assignment of the patient assessed the mRS (primary outcome), Barthel Index, NIHSS (National Institute of Health Stroke Scale), and SF-36 (secondary outcomes) scores
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: January 4, 2023
• Study Start: January 5, 2016
• Primary Completion: December 25, 2019
• Study Completion: April 30, 2021
• Last Updated: January 4, 2023

Record last verified: 2023-01