Health TrialsbyHealthPanel

Aspirin Continuation or Discontinuation in Conservative Treatment for Chronic Subdural Hematoma

ConditionChronic Subdural Hematoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTao Liu

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

Treatment groups

143 Participants
are divided into 2 treatment groups
Group A: Aspirin Continuation GroupExperimental treatment 1 intervention
Group B: Aspirin Discontinuation GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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

Time frame
at 6 months
2

Surgical conversion rate

Time frame
at 6 months
3

mortality

Time frame
at 6 months
4

Peripheral vascular events

Peripheral vascular events: including peripheral arterial occlusion (PAO), thromboembolic events (deep vein thrombosis, pulmonary embolism), and other peripheral hemorrhagic events.

Time frame
6 months

Other outcomes

Sponsors and contacts

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Tao Liu

Lead sponsor

The George Institute

Sponsor institution

Tianjin Medical University General Hospital

Collaborator

Xuanwu Hospital, Beijing

Collaborator

Source ClinicalTrials.gov
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