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NCT Number: NCT03120182

Chronic Subdural Hematoma and Aspirin

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acetylsalicylic acid

Drug

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

Other names: Aspirin

Placebo oral tablet

Drug

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

Other names: Placebo

Primary outcomes

  1. Revision surgery due to a recurrent subdural hematoma

    Time frame: 6 months

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

Secondary outcomes

  1. Myocardial infarction

    Time frame: 6 months

    (STEMI/non-STEMI)

  2. Stroke

    Time frame: 6 months

    cerebral stroke

  3. Peripheral arterial occlusion

    Time frame: 6 months

    occlusion of a peripheral artery

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

    Time frame: 6 months

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

  5. Intraoperative blood loss

    Time frame: on the operation day (up to 1 day)

    blood loss recorded during surgery

  6. Amount of blood/ fluid collected in the drain

    Time frame: up to 2 days, at removal of the drainage

    Amount of blood/ fluid collected in the drain

  7. Postoperative anemia

    Time frame: up to 7 days

    hemoglobin<80mg/L

  8. Operation time

    Time frame: during surgery

    Operation time

  9. Hospitalization time

    Time frame: an average of 7 days

    Hospitalization time

  10. Intraoperative blood transfusion rate

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

    blood transfusion rate intraoperatively

  11. Postoperative blood transfusion rate

    Time frame: during hospitalization, an average of 7 days

    blood transfusion rate postoperatively

  12. GCS Score

    Time frame: 6 months

    Glasgow Coma Scale

  13. mRS

    Time frame: 6 months

    modified Rankin scale

  14. GOS

    Time frame: 6 months

    Glasgow Outcome Scale

  15. Clinical outcome

    Time frame: 6 months

    Markwalder Score

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: SECA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2017
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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