Decompressive Craniectomy In Patients With Malignant Cerebellar Infarction: A Randomized, Controlled Trial in a Turkish Population (DEMCI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
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
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of cerebellar territory infarction with an NIHSS score ≥
- •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.
排除标准
- •Prestroke mRS score ≥
- •Prestroke score on the Barthel Index <
- •Score on the Glasgow Coma Scale ≤
- •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.
研究组 & 干预措施
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.
干预措施: suboccipital decompressive craniectomy (Procedure)
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.
结局指标
主要结局
The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score
时间窗: one year
The modified Rankin scale (mRS), which ranges from 0 \[no symptoms\] to 6 \[death\]).
次要结局
- NIHSS (National Institute of Health Stroke Scale)(1 year)
- Barthel Index,(1 year)
- Death(1 year)
研究者
Prof. Dr. Emre Kumral
Prof. Dr.
Ege University