Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma

NCT ID: NCT07240454

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2028-12-31

Brief Summary

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.

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.

Conditions

Chronic Subdural Hematoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aspirin Continuation

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Aspirin Discontinuation

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Tao Liu

OTHER

Sponsor Role: lead

Responsible Party

Tao Liu

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Xuanwu Hospital Capital Medical University

Beijing, , China

Site Status: RECRUITING

Tianjin Medical University General Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Liu, MD

Role: CONTACT

TLiu1@georgeinstitute.org.au

+86-18302204804

Facility Contacts

Tao Liu

Role: primary

TLiu1@georgeinstitute.org.au

+86-18302204804

Yu Qian

Role: primary

yqian@tmu.edu.cn

+86-16622511377

Other Identifiers

Aspirin CSDH

Identifier Type: -

Identifier Source: org_study_id