Actively Recruiting
Safety and Efficacy of Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma: A Randomized Clinical Trial
Led by Tao Liu · Updated on 2025-11-21
143
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Tao Liu
Lead Sponsor
T
Tianjin Medical University General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates the safety and effectiveness of continuing versus stopping aspirin in patients undergoing conservative treatment for chronic subdural hematoma (cSDH), a condition common in older adults often caused by minor head injuries. The study aims to resolve uncertainties about aspirin management in this group, as continuing aspirin may increase bleeding risk while stopping it might cause blood clots. This randomized clinical trial addresses an important gap, as current guidelines lack consensus on aspirin use during conservative care for cSDH. Participants receive standard conservative treatment for cSDH and are randomly assigned to either continue taking aspirin at 100 mg daily or to stop aspirin during treatment. Both groups follow the same non-surgical care plan. This trial does not involve surgery but focuses on medical management and monitoring over six months. The study compares outcomes between the aspirin continuation and discontinuation groups to inform better treatment decisions. During the study, participants will be closely monitored for changes in their subdural hematoma, neurological status, and any complications. Assessments include brain imaging, functional and cognitive tests, quality of life questionnaires, and tracking of cardiovascular events and adverse effects over six months. Researchers will measure hematoma recurrence or progression as the primary outcome and also evaluate disability levels, need for surgery, mortality, and other health events to understand the impact of aspirin use in conservative cSDH treatment.
CONDITIONS
Brief Title
Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Confirmed diagnosis of chronic subdural hematoma by cranial CT and/or MRI
- Planned for conservative management without surgical evacuation
- Regular aspirin use at the time of enrollment
- Signed informed consent by patient or legal representative
You will not qualify if you...
- Need for emergency surgery to remove hematoma at enrollment
- Concurrent use of other anticoagulants or antiplatelet agents that cannot be stopped
- Chronic subdural hematoma caused by other conditions such as ventriculoperitoneal shunt drainage or brain tumors
- Active bleeding or major cardiac events within 30 days before enrollment
- Known bleeding disorders like hemophilia or severe low platelets
- Unable to provide informed consent or expected difficulty completing follow-up
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive conservative treatment for chronic subdural hematoma with randomized aspirin continuation or discontinuation. The treatment involves daily oral aspirin administration at 100 mg for those continuing aspirin, or no aspirin for those discontinuing, alongside standard conservative management.
Regular visits during the 6-month treatment period
Duration - Up to 6 months after treatment start
Participants are monitored for recurrence, progression of hematoma, functional outcomes, and adverse events after the treatment period.
Follow-up visits to assess outcomes at 6 months
Trial Site Locations
Total: 2 locations
1
Xuanwu Hospital Capital Medical University
Beijing, China
Actively Recruiting
2
Tianjin Medical University General Hospital
Tianjin, China
Actively Recruiting
Research Team
T
Tao Liu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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