Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma

Safety and Efficacy of Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma: A Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Drug: Aspirin Continuation; Drug: Aspirin Discontinuation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 143
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Liu, MD; Phone Number: +86-18302204804; Email: TLiu1@georgeinstitute.org.au

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital Capital Medical University
    • Contact: Tao Liu; Phone Number: +86-18302204804; Email: TLiu1@georgeinstitute.org.au
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University General Hospital
    • Contact: Yu Qian; Phone Number: +86-16622511377; Email: yqian@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Aspirin Continuation; 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.
Experimental: 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.	Drug: Aspirin Discontinuation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 6 months
Surgical conversion rate		at 6 months
mortality		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.	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).	6 months
new-onset contralateral chronic subdural hematoma		6 months
Change in hematoma volume		6 months
EQ-5D-5L Questionnaire	EuroQol Group 5-Dimension 5-Level Self-Report Questionnaire	6 months
Montreal Cognitive Assessment Scale	Use the MoCA scale to assess cognitive function.	6 months
Red Blood Cell Lifespan		6 months
Other adverse events	Other adverse events: including liver and kidney function abnormalities, infections, anemia, etc.	6 months

Collaborators and Investigators

• Sponsor: Tao Liu
• Collaborators: Xuanwu Hospital, Beijing; Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Aspirin; Safety; Efficacy; Conservative Treatment; Randomized Clinical Trial; Chronic Subdural Hematoma; cSDH
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma, Subdural; Hematoma; Hematoma, Subdural, Chronic
• Other Study ID Numbers: Aspirin CSDH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No