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Completed

NCT Number: NCT05670249

Decompressive Craniectomy in Patients With Cerebellar Infarction

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.

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Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

suboccipital decompressive craniectomy

Procedure

extensive bilateral suboccipital decompressive craniectomy with duraplasty

Other names: space occupying surgey

Primary outcomes

  1. The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score

    Time frame: one year

    The modified Rankin scale (mRS), which ranges from 0 [no symptoms] to 6 [death]).

Secondary outcomes

  1. Death

    Time frame: 1 year

    Patient who died due to surgery

  2. Barthel Index,

    Time frame: 1 year

    Barthel index which ranges from 0 [dependent] to 100 [Totally independent)

  3. NIHSS (National Institute of Health Stroke Scale)

    Time frame: 1 year

    independent), NIHSS ranges from 0 to 42 (the higher the score, the more severe the stroke)

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Decompressive Craniectomy In Patients With Malignant Cerebellar Infarction: A Randomized, Controlled Trial in a Turkish Population (DEMCI Trial)

Acronym: DEMCI

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Jan 4, 2023
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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