Chronic Subdural Hematoma and Aspirin

NCT03120182 | Completed DMC

• 1 other identifier: SECA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Subdural Hematoma

Keywords

aspirin; bleeding risk; intracranial bleeding; burr-hole drainage; chronic subdural hematoma; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Revision surgery due to a recurrent subdural hematoma

  Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)

  6 months

Secondary Outcomes (15)

• Myocardial infarction

  6 months

• Stroke

  6 months

• Peripheral arterial occlusion

  6 months

• Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively

  6 months

• Intraoperative blood loss

  on the operation day (up to 1 day)

Study Arms (2)

Aspirin Arm

ACTIVE COMPARATOR

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

Drug: Acetylsalicylic acid

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Acetylsalicylic acid DRUG

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

Also known as: Aspirin

Aspirin Arm

Placebo Oral Tablet DRUG

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

Also known as: Placebo

Placebo Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Neurosurgery

Basel, 4053, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 40287938 DERIVED

• 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.

  PMID: 30665464 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Intracranial Hemorrhages

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; 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

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Luigi Mariani, Prof, MD

  Department of Neurosurgery, University Hospital Basel

  STUDY CHAIR

• Maria Kamenova, MD

  Department of Neurosurgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

• Jehuda Soleman, MD

  Department of Neurosurgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, placebo controlled, double blinded study

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 19, 2017
• Study Start: February 19, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)