Chronic Subdural Hematoma and Aspirin

NCT ID: NCT03120182

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-19
• Study Completion Date: 2023-12-31

Brief Summary

The aim of this randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for chronic subdural hematoma with and without discontinuation of low-dose aspirin

Detailed Description

Chronic subdural hematoma (cSDH) is one of the most common neurosurgical conditions. Its significantly higher prevalence among patients older than 65 (69%) versus younger (31%) explains why 41% of the patients are taking blood thinners. Antiplatelet therapy in patients with chronic subdural hematoma (cSDH) presents significant neurosurgical challenges. Studies investigating the effect of acetylsalicylic acid (ASA) in cranial neurosurgery are sparse and mostly based on case reports. Given the lack of guidelines regarding perioperative management with antiplatelet therapy, it is difficult to balance the patient's increased cardiovascular risk and prevalence of cSDH. The aim of our randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for cSDH with and without discontinuation of low-dose ASA. We will include patients receiving low-dose ASA as secondary prophylaxis for various reasons (e.g. coronary artery disease (CAD), cerebrovascular disease, etc.) and will randomize them either to a Placebo- or Aspirin-arm. The patients will receive placebo or ASA for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization. Our study primarily seeks to evaluate the risk of recurrence after burr-hole trepanation for cSDH under low-dose ASA treatment compared to placebo treatment. Secondary objectives are to assess the rate of thrombotic events, perioperative blood loss, postoperative anemia, intra- and postoperative blood transfusion rate, and clinical outcome (mRS, GOS, Markwalder score). The study will be performed in cooperation with the Department of Cardiology of the University Hospital of Basel.

Conditions

Chronic Subdural Hematoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aspirin Arm

The patients will receive acetylsalicylic acid (100mg once a day, orally) for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization

Group Type: ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type: DRUG

Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization

Placebo Arm

The patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Patients will receive placebo medication 100mg daily for 12 days after randomization

Interventions

Acetylsalicylic acid

Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization

Intervention Type: DRUG

Placebo Oral Tablet

Patients will receive placebo medication 100mg daily for 12 days after randomization

Intervention Type: DRUG

Other Intervention Names

Aspirin; Placebo

Eligibility Criteria

Inclusion Criteria

• Patients undergoing burr hole trepanation for cSDH who are under low-dose aspirin treatment ( Aspirin cardio 100mg once a day) for secondary prophylaxis

Exclusion Criteria

• Patients under the age of 18years
• A recent (30 days before randomization) major cardiac event (i.e. unstable angina, myocardial infarction, or coronary revascularization)
• A recent (30 days before randomization) active bleeding event.
• Patient with known bleeding disorder (e.g. hemophilia)
• No informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Mariani, Prof, MD

Role: STUDY_CHAIR

Department of Neurosurgery, University Hospital Basel

Maria Kamenova, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, University Hospital Basel

Jehuda Soleman, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, University Hospital Basel

Locations

Department of Neurosurgery

Basel, , Switzerland

Countries

Switzerland

References

Kamenova M, Pacan L, Mueller C, Coslovsky M, Lutz K, Marbacher S, Moser M, Hickmann AK, Zweifel C, Guzman R, Mariani L, Soleman J; SECA Investigators. Aspirin Continuation or Discontinuation in Surgically Treated Chronic Subdural Hematoma: A Randomized Clinical Trial. JAMA Neurol. 2025 Jun 1;82(6):551-559. doi: 10.1001/jamaneurol.2025.0850.

Reference Type: DERIVED

PMID: 40287938 (View on PubMed)

Kamenova M, Mueller C, Coslovsky M, Guzman R, Mariani L, Soleman J. Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study. Trials. 2019 Jan 21;20(1):70. doi: 10.1186/s13063-018-3064-y.

Reference Type: DERIVED

PMID: 30665464 (View on PubMed)

Other Identifiers

SECA

Identifier Type: -

Identifier Source: org_study_id