Chronic Subdural HematomaNCT07240454
Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma
A study testing Aspirin Continuation and Aspirin Discontinuation in people with Chronic Subdural Hematoma, run by Tao Liu at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Aspirin Continuation and Aspirin Discontinuation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesChina
- Study dates
- 15 Oct 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
Tao Liu, +86-18302204804, TLiu1@georgeinstitute.org.au
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Yu Qian, +86-16622511377, yqian@tmu.edu.cn
About this study
Official title: Safety and Efficacy of Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma: A Randomized Clinical Trial
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.
Read the 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
- Being tested
- Aspirin Continuation, Aspirin Discontinuation
- Keywords
- Chronic Subdural Hematoma, Aspirin, Conservative Treatment, Randomized Clinical Trial, Safety, Efficacy, cSDH
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin ContinuationDrug
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 DiscontinuationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin Continuation Group | Experimental | 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. Receives: Drug: Aspirin Continuation |
| Aspirin Discontinuation Group | Experimental | 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. Receives: Drug: Aspirin Discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence or progression of the subdural hematoma
The primary outcome was defined as recurrence or progression of the subdural hematoma at 6 months, confirmed by positive radiological findings with or without associated clinical symptoms, necessitating additional pharmacological or surgical intervention. Positive radiological findings were defined as reappearance of ipsilateral CSDH with a midline shift greater than 5 mm at 6 months；a maximum hematoma thickness exceeding 10 mm at 6 months; or an increase in maximum hematoma thickness of more than 3 mm.
Measured: 6 months
Secondary outcomes (11)
modified Rankin Score (mRS)
0=no symptoms, 1=no significant disability, 2=slight disability, 3= moderate disability, 4=moderate severe disability, 5=severe disability, 6=death
Measured: at 6 months
Surgical conversion rate
Measured: at 6 months
mortality
Measured: at 6 months
Peripheral vascular events
Peripheral vascular events: including peripheral arterial occlusion (PAO), thromboembolic events (deep vein thrombosis, pulmonary embolism), and other peripheral hemorrhagic events.
Measured: 6 months
Acute cardiovascular and cerebrovascular events
Acute cardiovascular and cerebrovascular events: including stroke (hemorrhagic stroke, ischemic stroke), or cardiovascular events such as myocardial infarction or injury (PMI), ST-segment elevation myocardial injury (STEMI), and non-ST-segment elevation myocardial infarction (NSTEMI).
Measured: 6 months
new-onset contralateral chronic subdural hematoma
Measured: 6 months
Change in hematoma volume
Measured: 6 months
EQ-5D-5L Questionnaire
EuroQol Group 5-Dimension 5-Level Self-Report Questionnaire
Measured: 6 months
Montreal Cognitive Assessment Scale
Use the MoCA scale to assess cognitive function.
Measured: 6 months
Red Blood Cell Lifespan
Measured: 6 months
Other adverse events
Other adverse events: including liver and kidney function abnormalities, infections, anemia, etc.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing
- Responsible party
- Sponsor-investigator, Tao Liu, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240454
- Sponsor's protocol ID
- Aspirin CSDH
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07240454
- Acronym / sponsor ID
- Aspirin CSDH
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Chronic Subdural Hematoma, Aspirin, Conservative Treatment, Randomized Clinical Trial, Safety, Efficacy, cSDH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Tao LiuUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Xuanwu Hospital, Beijing
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin Continuation Group | Experimental | Drug: Aspirin ContinuationAll 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 | Experimental | Drug: Aspirin DiscontinuationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin ContinuationAll 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. | Drug | Aspirin Continuation Group |
| Aspirin DiscontinuationAll 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. | Drug | Aspirin Discontinuation Group |
Primary outcome
recurrence or progression of the subdural hematoma
Time frame: 6 months
The primary outcome was defined as recurrence or progression of the subdural hematoma at 6 months, confirmed by positive radiological findings with or without associated clinical symptoms, necessitating additional pharmacological or surgical intervention. Positive radiological findings were defined as reappearance of ipsilateral CSDH with a midline shift greater than 5 mm at 6 months；a maximum hematoma thickness exceeding 10 mm at 6 months; or an increase in maximum hematoma thickness of more than 3 mm.
11 secondary outcomes
modified Rankin Score (mRS)
Time frame: at 6 months
Surgical conversion rate
Time frame: at 6 months
mortality
Time frame: at 6 months
Peripheral vascular events
Time frame: 6 months
Acute cardiovascular and cerebrovascular events
Time frame: 6 months
new-onset contralateral chronic subdural hematoma
Time frame: 6 months
Change in hematoma volume
Time frame: 6 months
EQ-5D-5L Questionnaire
Time frame: 6 months
Montreal Cognitive Assessment Scale
Time frame: 6 months
Red Blood Cell Lifespan
Time frame: 6 months
Other adverse events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin Continuation and Aspirin Discontinuation in people with Chronic Subdural Hematoma, run by Tao Liu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Liu, MD (+86-18302204804, TLiu1@georgeinstitute.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence or progression of the subdural hematoma (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.