Effectiveness and Safety of Low Intracranial Pressure Treatment Strategies for Patients With Chronic Subdural Hematoma - A Randomized, Controlled, Multi-center Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
The proportion of the elderly population is increasing rapidly. Chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. The standard treatment for cSDH is mostly surgery. Clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. At present, the mechanism of cSDH is not completely clear. Our previous observational studies had shown significant correlation between cSDH and intracranial hypotension. So we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients above 14 yrs with chronic subdural hematoma confirmed by cranial imaging;
- •patients with MGS-GCS score ≤1 point, showing no signs of neurological deficits caused by CSDH or characteristics of high intracranial pressure;
- •patients with MGS-GCS score ≥1 point, but with medication history of anticoagulant or antiplatelet drugs, coagulation dysfunction so that they are unsuitable or intolerant of surgery although they are in stable condition;
- •patients who are unwilling to operate when they have no life-threatening brain herniation or no indications for emergency surgery, which confirmed by two neurosurgeons
排除标准
- •women pregnant or in lactation
- •those who are allergic to atorvastatin, hypoxamethasone;
- •patients with brain herniation or altered mental status;
- •patients with primary diseases like tumors, hemorrhagic diseases or some other critically serious conditions( eg.multiple organ failure);
- •patients with uncontrollable diabetes and heart failure
- •patients with preexisting chronic abdominal diseases (such as inflammatory bowel disease) or lung tumors or digestive system neoplasm
- •Patients with abnormal liver function
- •patients had taken atorvastatin or dexamethasone, ACEI in the past one week
- •other conditions not eligible to enroll the trial confirmed by two individual doctor
研究组 & 干预措施
Atorvastatin plus Dexamethasone tablets
干预措施: Atorvastatin plus Dexamethasone (Drug)
drugs+low intracranial pressure strategy treatment
Drugs means treatment with Atorvastatin plus Dexamethasone tablets
干预措施: low intracranial pressure strategy treatment (Behavioral)
drugs+low intracranial pressure strategy treatment
Drugs means treatment with Atorvastatin plus Dexamethasone tablets
干预措施: Atorvastatin plus Dexamethasone (Drug)
结局指标
主要结局
Modified Rankin Scale
时间窗: three months
difference of Modified Rankin Scale between two groups; The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.
Extended Glasgow Outcome score
时间窗: three months
difference of Extended Glasgow Outcome score between two groups; This score is used to measure the outcome after neurological disease. It defines 5 categories of possible outcomes after a brain injury, which is from good recovery(5) to death(1).
subdural hematoma volume
时间窗: three months
difference of hematoma volume in subdura between two groups
Markwalder scale
时间窗: three months
difference of Markwalder scale between two groups;The Markwalder Scale is designed to measure the chronic subdural hematoma scale. This scale is categorized into four grade. Grade 0 denots the patient neurologically normal, whereas grade 4, the highest grade, denotes the worst neuological assessment.
次要结局
未报告次要终点