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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's enrollment of 150 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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Studies of the drug tested here: Aspirin
University Hospital, Basel, Switzerland →