An interventional study of Acetylsalicylic acid and Placebo Oral Tablet in Chronic Subdural Hematoma, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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
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.
Exclusion Criteria:
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
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
Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization
Also known as: Aspirin
Patients will receive placebo medication 100mg daily for 12 days after randomization
Also known as: Placebo
Revision surgery due to a recurrent subdural hematoma
Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)
Time frame: 6 months
Myocardial infarction
(STEMI/non-STEMI)
Time frame: 6 months
Stroke
cerebral stroke
Time frame: 6 months
Peripheral arterial occlusion
occlusion of a peripheral artery
Time frame: 6 months
Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively
acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding)
Time frame: 6 months
Intraoperative blood loss
blood loss recorded during surgery
Time frame: on the operation day (up to 1 day)
Amount of blood/ fluid collected in the drain
Amount of blood/ fluid collected in the drain
Time frame: up to 2 days, at removal of the drainage
Postoperative anemia
hemoglobin\<80mg/L
Time frame: up to 7 days
Operation time
Operation time
Time frame: during surgery
Hospitalization time
Hospitalization time
Time frame: an average of 7 days
Intraoperative blood transfusion rate
blood transfusion rate intraoperatively
Time frame: during surgery (e.g. up to 1 day)
Postoperative blood transfusion rate
blood transfusion rate postoperatively
Time frame: during hospitalization, an average of 7 days
GCS Score
Glasgow Coma Scale
Time frame: 6 months
mRS
modified Rankin scale
Time frame: 6 months
GOS
Glasgow Outcome Scale
Time frame: 6 months
Clinical outcome
Markwalder Score
Time frame: 6 months
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland