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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 143 (estimated) |
| Sponsor | The George Institute Academic / other |
| Locations | 2 sites (Beijing and 1 other locations) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07240454 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
- Study coordinator: Tao Liu, MD
- Email: TLiu1@georgeinstitute.org.au
- Phone: +86-18302204804
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Middle Meningeal Artery Embolisation to Prevent Recurrence of Chronic Subdural Hematoma
This study tests whether embolising the middle meningeal artery around the time of hematoma evacuation can reduce recurrence in adults with chronic subdural hematoma.
-
What causes vulnerability in older adults with serious diseases and how it affects care decisions
This study tests how often vulnerability factors appear in older adults with serious illnesses and how these factors influence treatment timing, survival, and quality of life.
-
Coil embolization for unilateral vs bilateral chronic subdural hematomas
This trial tests whether unilateral or bilateral coil-based embolization of the middle meningeal artery helps people with chronic subdural hematoma.
-
Non-Thermal Plasma Used During Surgery to Help Prevent Recurrent Chronic Subdural Hematoma
A randomized trial tests whether applying non-thermal plasma during standard surgery to drain a chronic subdural hematoma can reduce recurrence within 6 months.
-
Enhanced recovery pathway for burr-hole drainage in chronic subdural hematoma patients
This project tests whether an enhanced recovery protocol for adults having burr-hole drainage for chronic subdural hematoma can reduce recurrence and complications compared with past patients.
-
Matched microcatheter and guidewire use for middle meningeal artery embolization in chronic subdural hematoma
This will test whether using a matched Aristotle 14 guidewire and Plato 17 microcatheter during middle meningeal artery embolization works better than surgeons' usual device choices for adults with chronic subdural hematoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.