Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma

NCT07240454 | Recruiting DMC

• 1 other identifier: Aspirin CSDH
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Chronic Subdural Hematoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (11)

• modified Rankin Score (mRS)

  at 6 months

• Surgical conversion rate

  at 6 months

• mortality

  at 6 months

• Peripheral vascular events

  6 months

• Acute cardiovascular and cerebrovascular events

  6 months

Study Arms (2)

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.

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.

Drug: Aspirin Discontinuation

Interventions

Aspirin Continuation DRUG

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 Continuation Group

Aspirin Discontinuation DRUG

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.

Aspirin Discontinuation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tao Liu: lead
• Tianjin Medical University General Hospital: collaborator
• Xuanwu Hospital, Beijing: collaborator

Study Sites (2)

Xuanwu Hospital Capital Medical University

Beijing, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Central Study Contacts

Tao Liu, MD

CONTACT

+86-18302204804; TLiu1@georgeinstitute.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-10

Locations

CN (2)