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
The BP-CSDH study is a prospective, multicentre, open-label, randomised controlled trial with blinded endpoint assessment. 830 eligible patients will be randomised 1:1 to body posture therapy group or the control group. Follow-up assessments will be conducted at 30 days (±7 days), 90 days (±10 days) and 365 days(±30 days) post-surgery.
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 subdural 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
- •have brain hernia or acute massive cerebral infarction that have to perform craniotomy
- •have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
- •Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
- •Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
- •Patients with cranial CT demonstrating no significant compression or displacement of brain tissue, asymptomatic presentation, and unaffected daily activities were deemed ineligible for surgical intervention by neurosurgeons;
- •CSDH persisting for over 1 year and exhibiting marked organization/solidification of the hematoma;
- •CSDH caused by over V-P shunting;
- •during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
- •Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;
- •have deep venous thrombosis of lower extremity or pulmonary embolism;
- •cannot complete 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.
研究组 & 干预措施
body posture group
In-hospital protocol of Intracranial Hypotension Targeted(IHT) Body Posture
- Upper body horizontal and lower limbs elevated 30°, except for postprandial 2 hours to prevent reflux;
- For unilateral CSDH: Affected side lateral decubitus combined with intermittent supine positioning; Nonaffected side decubitus should be avoided;
- For bilateral CSDH: No specific head position requirements;
- Body posture therapy was initiated immediately after randomization and maintained for 14-18 hours daily.
- Daily documentation of body posture therapy duration and bed rest time in diary cards.
Post-discharge: patients received stage-stratified body posture therapy education Month 1: Perform body posture therapy during bed rest, minimum 6 hours daily. Months 2-3: Based on 1 month CT/MRI:(1) Complete/near-complete hematoma resolution: Continue therapy ≥1 hour/day.
(2) Persistent significant subdural hematoma: Maintain therapy≥6 hours/day until Month 3.
干预措施: Intracranial Hypotension Targeted(IHT) Body Posture (Behavioral)
control group
Patients will be required to keep supine position. In addition to body posture therapy, patients will receive treatment as same as body posture group.
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 MGS-GCS score compared to baseline(90±10 days post-surgery)
- change in modified Rankin Scale(mRS) compared to baseline(90±10 days post-surgery)
- change in EQ-5D-5L score compared to baseline(90±10 days post-surgery)
研究者
Xuehai Wu
Professor, Huashan Hospital
Huashan Hospital