NCT02024373已完成2 期
Multi-Center, Randomized, Placebo-Controlled, Double Blind Study of the Atorvastatin: Effect on Patients With Chronic Subdural Hematoma
Oriental Neurosurgery Evidence-Based-Study Team31 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 31
- 主要终点
- Hematoma Reduced Amount.
研究概览
简要总结
To evaluate the clinic effects and security of oral administration of Atorvastatin on chronic subdural hematoma (CSDH).
详细描述
Study design:
Multi-center, randomized, double-blind, placebo parallel controlled
Subjects:
Patients with chronic subdural hematoma (CSDH)
Sample size:
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and <90 years old, male or female;
- •CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
- •Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)<Grade 3;
- •Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted;
- •Patients have never undergo surgery on the hematoma
- •Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.
排除标准
- •Allergic to the statin or its ingredients
- •Cerebral herniation might occur at any time;
- •Hematoma leads to herniation and warrants surgical operation.
- •Hematoma caused by tumors, blood and other known comorbidities;
- •Abnormal liver function
- •Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study
- •Patients have been on oral Statin treatment for a long time.
- •Patients have been on oral Steroids treatment for a long time.
- •Participate in clinical trials in the past four weeks;
- •Pregnant or breastfeeding
- •Failure of completing the trial by poor compliance;
- •For any reason, the researchers believe that the case is not suitable for inclusion.
研究组 & 干预措施
Atorvastatin
Experimental
atorvastatin：20 mg (every evening orally) for 8 weeks
干预措施: Atorvastatin (Drug)
placebo
Placebo Comparator
placebo:20 mg (every evening orally) for 8 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Hematoma Reduced Amount.
时间窗: Check on 8 weeks during treatment (at the end)
The primary efficacy endpoint: hematoma reduced amount. Outcome Measures: all patients underwent head CT (plain scan) before treatment, and check on 8 weeks during treatment (at the end)
次要结局
- Hematoma Reduced Amount(4 weeks during treatment, in the follow-up in 12 and 24 weeks.)
- The consciousness score (MGS-GCS) and outcome score (GOS, ADL-BI Scale) in subjects(0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.)
- Changes of routine blood test and coagulation results(0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.)
- Changes of neurological symptoms and signs(0，7days，4, 8weeks during treatment (at the end), in the follow-up in 12 and 24 weeks.)
研究者
研究点 (31)
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