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Chronic Subdural HematomaSECANCT03120182

Chronic Subdural Hematoma and Aspirin

A study testing Acetylsalicylic acid in people with Chronic Subdural Hematoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 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?
Acetylsalicylic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteSwitzerland
Study dates
19 Feb 2018to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Neurosurgery

    Basel, 4053

Other trials in Switzerland

About this study

Official title: Impact of Perioperative Maintenance or Interruption of Low-dose Aspirin on Recurrence Rate and Thrombotic Events After Burr-hole Drainage of Chronic Subdural Hematoma: a Randomized, Placebo Controlled, Double Blinded Study

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

Read the 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.

Being tested
Acetylsalicylic acid, Placebo Oral Tablet
Keywords
aspirin, bleeding risk, intracranial bleeding, burr-hole drainage, chronic subdural hematoma, anticoagulation
Medical subject headings
Hematoma, Subdural, Chronic, Intracranial Hemorrhages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetylsalicylic acidDrug

    Also called Aspirin

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

  • Placebo Oral TabletDrug

    Also called Placebo

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

Study groups in NCT03120182
Study groupRoleWhat they receive
Aspirin ArmActive comparatorThe 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
Receives: Drug: Acetylsalicylic acid
Placebo ArmPlacebo comparatorThe patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Revision surgery due to a recurrent subdural hematoma

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

    Measured: 6 months

Secondary outcomes (15)

  1. Myocardial infarction

    (STEMI/non-STEMI)

    Measured: 6 months

  2. Stroke

    cerebral stroke

    Measured: 6 months

  3. Peripheral arterial occlusion

    occlusion of a peripheral artery

    Measured: 6 months

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

    acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding)

    Measured: 6 months

  5. Intraoperative blood loss

    blood loss recorded during surgery

    Measured: on the operation day (up to 1 day)

  6. Amount of blood/ fluid collected in the drain

    Amount of blood/ fluid collected in the drain

    Measured: up to 2 days, at removal of the drainage

  7. Postoperative anemia

    hemoglobin<80mg/L

    Measured: up to 7 days

  8. Operation time

    Operation time

    Measured: during surgery

  9. Hospitalization time

    Hospitalization time

    Measured: an average of 7 days

  10. Intraoperative blood transfusion rate

    blood transfusion rate intraoperatively

    Measured: during surgery (e.g. up to 1 day)

  11. Postoperative blood transfusion rate

    blood transfusion rate postoperatively

    Measured: during hospitalization, an average of 7 days

  12. GCS Score

    Glasgow Coma Scale

    Measured: 6 months

  13. mRS

    modified Rankin scale

    Measured: 6 months

  14. GOS

    Glasgow Outcome Scale

    Measured: 6 months

  15. Clinical outcome

    Markwalder Score

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2017
  2. Study start19 Feb 2018
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

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
Model description
randomized, placebo controlled, double blinded study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03120182
Sponsor's protocol ID
SECA
Acronym
SECA
Status last verified
May 2024
First submitted
10 Apr 2017
Last updated
13 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40287938

  • 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.

    PubMed 30665464

Questions about this trial

What is this clinical trial studying?

A study testing Acetylsalicylic acid in people with Chronic Subdural Hematoma, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

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 1 inclusion and 5 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: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Revision surgery due to a recurrent 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?

On the ClinicalTrials.gov record for NCT03120182, which also lists 2 linked publications.

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 13 May 2024.

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