An interventional study of Aspirin Continuation and Aspirin Discontinuation in Chronic Subdural Hematoma, sponsored by Tao Liu. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Tao Liu · Not applicable, Interventional, and Treatment
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.
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.
114 studies on the registry are indexed under Hematoma, Subdural, Chronic; 48 are open to participants now.
This study's planned enrollment of 143 is below the median of 164 across 87 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Tao Liu is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Drug: Aspirin Continuation
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.
Drug: Aspirin Discontinuation
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.
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.
recurrence or progression of the subdural hematoma
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.
Time frame: 6 months
modified Rankin Score (mRS)
0=no symptoms, 1=no significant disability, 2=slight disability, 3= moderate disability, 4=moderate severe disability, 5=severe disability, 6=death
Time frame: at 6 months
Surgical conversion rate
Time frame: at 6 months
mortality
Time frame: at 6 months
Peripheral vascular events
Peripheral vascular events: including peripheral arterial occlusion (PAO), thromboembolic events (deep vein thrombosis, pulmonary embolism), and other peripheral hemorrhagic events.
Time frame: 6 months
Acute cardiovascular and cerebrovascular events
Acute cardiovascular and cerebrovascular events: including stroke (hemorrhagic stroke, ischemic stroke), or cardiovascular events such as myocardial infarction or injury (PMI), ST-segment elevation myocardial injury (STEMI), and non-ST-segment elevation myocardial infarction (NSTEMI).
Time frame: 6 months
new-onset contralateral chronic subdural hematoma
Time frame: 6 months
Change in hematoma volume
Time frame: 6 months
EQ-5D-5L Questionnaire
EuroQol Group 5-Dimension 5-Level Self-Report Questionnaire
Time frame: 6 months
Montreal Cognitive Assessment Scale
Use the MoCA scale to assess cognitive function.
Time frame: 6 months
Red Blood Cell Lifespan
Time frame: 6 months
Other adverse events
Other adverse events: including liver and kidney function abnormalities, infections, anemia, etc.
Time frame: 6 months
Plan to share: Undecided
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Tao Liu