The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of hematoma volume
研究概览
简要总结
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
详细描述
Study design: Two-arm,Evaluator-blinded study
Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted）
Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in Atorvastatin-treated group.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and<90years old, both gender;
- •Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;
- •CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult);
- •The midline shift to less than 1 cm;
- •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 and dexamethasone or its ingredients;
- •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 in the past four weeks;
- •Patients have been on oral Steroids treatment for a long time;
- •Diagnosed Diabetes patients with poorly controlled blood glucose
- •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 and Dexamethasone
Atorvastatin: 20 mg (every evening orally) for 5 weeks;
Dexamethasone: 0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)
干预措施: Atorvastatin and Dexamethasone (Drug)
Atorvastatin
Atorvastatin: 20 mg (every evening orally) for 5 weeks
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Changes of hematoma volume
时间窗: 2,5,12 weeks during treatment
After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.
次要结局
- Outcome score (GOSE) in subjects(2,5,12 weeks during treatment)
- Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis(2,5,12 weeks during treatment)
- Changes of neurological symptoms and signs(2,5,12 weeks during treatment)
- Recurrence and prognosis of patient failure in those conservative treatment(2,5,12 weeks during treatment)
- Outcome score (ADL-BI Scale) in subjects(2,5,12 weeks during treatment)