The Effectiveness and Safety of Body Posture to Improve Intracranial Pressure in Preventing Postoperative Recurrence for Chronic Subdural Hematoma (BP-CSDH) -A Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 830
- 试验地点
- 1
- 主要终点
- subdural hematoma recurrence rate
研究概览
简要总结
This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma
详细描述
This study is a multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment to evaluate the effects of body posture on hematoma recurrence. Patients will be assigned in a 1:1 ratio to body posture group(upper body lay flat, lower body elevate 30° or 20-30cm, head turn to affected side) or control group(supine position) randomly. After operation, patients will be required to keep respective body posture at sleep time for 3 months. Instead of body posture, patients will receive routine treatment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
- •more than 60 years of age or 60 years;
- •MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
- •patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc.
- •receive burr hole drainage;
- •sign informed consent voluntarily.
排除标准
- •pregnancy or lactation;
- •have hernia of brain or acute massive cerebral infarction that have to perform craniotomy
- •have serous cancer, hemorrhagic disease, cardiac dysfunction and other serious disease that may aggravate patient's condition and impact follow-up;
- •patients can not stay in bed for long-term due to mental illness or spinal disease(kyphotic deformity);
- •CT scan showed that no obvious brain compression or midline shift; no symptom before surgery; neurosurgeon evaluate that patients do not require surgery;
- •have CSDH for more than 1 year or organized hematoma;
- •CSDH caused by over V-P shunting;
- •during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
- •during burr hole drainage, patients have cerebral contusion or drainage catheter insert into brain unexpectedly;
- •have venous thrombosis of lower extremity or pulmonary embolism;
- •cannot regular reexamine within 1 year for any reason;
- •life expectancy less than 1 year;
- •participating other ongoing clinical trial;
- •patients are not qualified for other reason evaluated by two neurosurgeons;
- •have bile reflux gastritis and esophageal diseases.
结局指标
主要结局
subdural hematoma recurrence rate
时间窗: within 90±10 days post-surgery
Hematoma recurrence was defined as the presence of symptoms attributable to subdural hematoma after surgery, accompanied by a maximum hematoma thickness exceeding 10 mm on imaging, excluding hemorrhage caused by new head trauma
次要结局
- change in EQ-5D-5L score compared to baseline(90days and 1year post-surgery)
- differences between two group in comorbidities(90days post-surgery)
- subdural hematoma recurrence rate(1year post-surgery)
- change in modified Rankin Scale(mRS) compared to baseline(90days and 1year post-surgery)
- differences between two group in complications(90day post-surgery)
- differences between two group in recurrence time(within 90days and 1year post-surgery)
- all cause recurrence rate(90days and 1year post-surgery)
研究者
Xuehai Wu
Professor, Huashan Hospital
Huashan Hospital