Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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

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

Run by The George Institute · NCT07240454 · Data updated 2026-11-12

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.

More Chronic Subdural Hematoma trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment143 (estimated)
SponsorThe George Institute
Academic / other
Locations2 sites (Beijing and 1 other locations)
StatusRecruiting
StartedOctober 15, 2025
Main results expectedDecember 2027
Study endsDecember 2028
Registry record updatedNovember 21, 2025
Trial IDNCT07240454 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.