Safety and Efficacy of Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- recurrence or progression of the subdural hematoma
研究概览
简要总结
This clinical study aims to learn about the efficacy and safety of aspirin continuation or discontinuation in conservative treatment for chronic subdural hematoma. All participants received standard conservative treatment for chronic subdural hematoma, with a randomized intervention to either continue or discontinue aspirin administration. By participating in this study, participants can receive additional scientific guidance on aspirin medication management beyond routine conservative treatment, thereby optimizing individualized therapy.
详细描述
Chronic subdural hematoma is a common condition in neurosurgery, predominantly affecting the elderly. Its incidence increases with age, often developing gradually following minor head trauma. Clinical manifestations vary widely, with severe cases potentially leading to coma or even death, imposing a significant burden on patients and their families.
Current treatment approaches for chronic subdural hematoma include surgical intervention and conservative management. Conservative treatment is suitable for some patients with milder conditions or high surgical risk, primarily involving bed rest and medication. However, its efficacy varies among individuals, and close monitoring for multiple potential complications is essential throughout the treatment process.
Aspirin, a commonly used antiplatelet agent, is widely applied in the prevention and treatment of cardiovascular and cerebrovascular diseases. Its use in chronic subdural hematoma patients presents complexities: some patients had been taking aspirin long-term prior to onset. Whether to continue aspirin during conservative management remains controversial, necessitating further research to clarify its safety and efficacy. Continuing the medication may increase the risk of hematoma enlargement, while discontinuation may trigger thromboembolic events.
For cSDH patients on long-term aspirin therapy who opt for conservative management, there is currently no guideline or consensus on "continue vs. discontinue." Clinical decisions are often made by multidisciplinary teams (MDTs) based on individualized risk assessment of bleeding versus thrombosis (with a higher rate of discontinuation strategies). A randomized controlled trial in surgical patients (JAMA Neurology, 2025) showed that discontinuing aspirin after surgery did not reduce 6-month recurrence, and discontinuation-related complications showed no significant difference, suggesting that a "one-size-fits-all" discontinuation approach is unreasonable. However, this evidence cannot be extrapolated to the conservative treatment population, making the conduct of this RCT practically necessary.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male or female;
- •Confirmed diagnosis of chronic subdural hematoma (cSDH) by cranial CT and/or MRI;
- •Intended for conservative management (i.e., no surgical evacuation indication at enrollment);
- •Regular aspirin use at enrollment;
- •Informed consent signed by the patient or legal representative.
排除标准
- •Patients requiring emergency surgery to remove hematoma at enrollment;
- •Concurrent use of other anticoagulants or antiplatelet agents that cannot be discontinued according to the study protocol;
- •cSDH secondary to other diseases or conditions (e.g., excessive drainage from ventriculoperitoneal shunts, intracranial tumors);
- •Active bleeding events or major cardiac events (e.g., acute myocardial infarction, unstable angina, or revascularization surgery) within 30 days prior to enrollment;
- •Known bleeding disorders (e.g., hemophilia, severe thrombocytopenia);
- •Individuals unable to provide informed consent or for whom completion of follow-up is anticipated to be difficult.
研究组 & 干预措施
Aspirin Continuation Group
All participants received standard conservative treatment for chronic subdural hematoma, with a randomized intervention to continue aspirin administration. This group of participants received oral administration of aspirin at a dose of 100 mg per day.
干预措施: Aspirin Continuation (Drug)
Aspirin Discontinuation Group
All participants received standard conservative treatment for chronic subdural hematoma, with a randomized intervention to discontinue aspirin administration. This group of participants did not use aspirin during the treatment period.
干预措施: Aspirin Discontinuation (Drug)
结局指标
主要结局
recurrence or progression of the subdural hematoma
时间窗: 6 months
The primary outcome was defined as recurrence or progression of the subdural hematoma at 6 months, confirmed by positive radiological findings with or without associated clinical symptoms, necessitating additional pharmacological or surgical intervention. Positive radiological findings were defined as reappearance of ipsilateral CSDH with a midline shift greater than 5 mm at 6 months；a maximum hematoma thickness exceeding 10 mm at 6 months; or an increase in maximum hematoma thickness of more than 3 mm.
次要结局
- modified Rankin Score (mRS)(at 6 months)
- Surgical conversion rate(at 6 months)
- mortality(at 6 months)
- Peripheral vascular events(6 months)
- Acute cardiovascular and cerebrovascular events(6 months)
- new-onset contralateral chronic subdural hematoma(6 months)
- Change in hematoma volume(6 months)
- EQ-5D-5L Questionnaire(6 months)
- Montreal Cognitive Assessment Scale(6 months)
- Red Blood Cell Lifespan(6 months)
- Other adverse events(6 months)
研究者
Tao Liu
MD
The George Institute