Continuing versus stopping aspirin during non-surgical management of chronic subdural hematoma

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

This test tries to see if continuing aspirin or stopping it is safer and leads to better outcomes for adults with chronic subdural hematoma who are being treated without surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 143 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The George Institute (Academic / other)
• Locations: 2 sites (Beijing and 1 other locations)
• Trial ID: NCT07240454 on ClinicalTrials.gov

What this trial studies

This randomized trial assigns adults with chronic subdural hematoma who are already taking aspirin and managed conservatively to either continue aspirin or discontinue it while receiving standard non-surgical care. Participants receive routine conservative measures and close clinical and imaging follow-up to monitor for hematoma enlargement, neurological changes, or thromboembolic events. The study compares safety outcomes (hematoma growth, bleeding) and thrombotic complications between the two groups. Results are intended to inform individualized aspirin management when surgery is not indicated.

Who should consider this trial

Good fit: Adults (≥18) with image-confirmed chronic subdural hematoma who are on regular aspirin and chosen for conservative (non‑surgical) management, and who can give informed consent.

Not a fit: Patients who need emergency surgical evacuation, cannot stop or are taking other anticoagulants/antiplatelets that conflict with the protocol, have active major bleeding, known bleeding disorders, or recent major cardiac events are unlikely to benefit.

Why it matters

Potential benefit: If successful, the results could provide clear guidance on whether to keep or stop aspirin to reduce the risk of hematoma enlargement without increasing thrombotic events.

How similar studies have performed: Most prior work on this question has been observational with mixed findings, so randomized evidence on continuing versus stopping aspirin in conservatively managed cSDH is limited.

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.

Where this trial is running

Beijing and 1 other locations

• Xuanwu Hospital Capital Medical University — Beijing, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Tao Liu, MD

Conditions Chronic Subdural Hematoma; Aspirin; Conservative Treatment; Randomized Clinical Trial; Safety; Efficacy; cSDH