Treatment of Chronic Subdural Hematoma by Corticosteroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 17
- 主要终点
- Delay of occurrence of surgical treatment of the Chronic subdural hematomas
研究概览
简要总结
Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural hematoma involves numerous inflammatory processes which could be inhibited by steroids.
详细描述
The primary objective is to evaluate the efficacy of corticosteroids treatment in patients with Chronic subdural hematomas without clinical or radiological signs of severity.
Secondary objectives are to assess the effect of methylprednisolone on:
- quality of life evolution,
- morbidity and mortality,
- radiological evolution of the lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old,
- •With chronic or subacute, uni or bilateral subdural hematoma,
- •Confirmed by cerebral scan without contrast enhancement,
- •Without clinical and radiological signs of severity,
- •Written informed consent from patients or their next of kin according to the patients cognitive status.
排除标准
- •Diabetics patients,
- •Contraindication for methylprednisolone,
- •Previous surgery for chronic subdural hematoma during the past 6 months,
- •Pre-existing severe dementia related to other etiology than the Chronic subdural hematomas,
- •Existing neurological pathology that can be associated with dementia,
- •Patients treated with corticosteroids,
- •Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor),
- •Participating in other concomitant research.
研究组 & 干预措施
Methylprednisolone
Methylprednisolone will be supplied as powder and stored in capsules containing 16 mg with lactose as excipient.
Capsules will be administered orally in the morning, during breakfast with a glass of water.
Dose is adapted according to the weight of the patient (1mg/kg):
- <60 kg: 3 pills of 16 mg/day
- 60-80kg: 4 pills of 16 mg/day
- >80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days.
干预措施: Methylprednisolone (Drug)
Placebo
Placebo capsules will only contain lactose. Capsules will be administered orally in the morning, during breakfast with a glass of water.
Dose is adapted according to the weight of the patient (1mg/kg):
- <60 kg: 3 pills of 16 mg/day
- 60-80kg: 4 pills of 16 mg/day
- >80kg: 5 pills of 16 mg/day The duration of the treatment is 21 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Delay of occurrence of surgical treatment of the Chronic subdural hematomas
时间窗: 1 month
次要结局
- Functional scales : cognitive(1, 3 and 6 months)
- Quality of life score(1, 3 and 6 months)
- Occurrence of adverse events potentially related to methylprednisolone(during the first 6 months)
- Survival(6 months)
- Radiological improvement(1, 3 and 6 months)
- Potassium(day 0, 7, 14, and 21 and 1 month)
- Fasting glucose(day 0, 7, 14, and 21 and 1 month)
- Rate of surgical treatment of the Chronic subdural hematomas(1, 3 and 6 months)
- Functional scales : daily living(1, 3 and 6 months)
- Plasma sodium(day 0, 7, 14, and 21 and 1 month)
- Time to surgical treatment(during the first 6 months)
- Functional scales : modified Rankin Scale(1, 3 and 6 months)