Department of Neurosurgery
Basel, 4053, Switzerland
NCT Number: NCT03120182
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Basel, 4053, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization
Other names: Aspirin
Patients will receive placebo medication 100mg daily for 12 days after randomization
Other names: Placebo
Time frame: 6 months
Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)
Time frame: 6 months
(STEMI/non-STEMI)
Time frame: 6 months
cerebral stroke
Time frame: 6 months
occlusion of a peripheral artery
Time frame: 6 months
acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding)
Time frame: on the operation day (up to 1 day)
blood loss recorded during surgery
Time frame: up to 2 days, at removal of the drainage
Amount of blood/ fluid collected in the drain
Time frame: up to 7 days
hemoglobin<80mg/L
Time frame: during surgery
Operation time
Time frame: an average of 7 days
Hospitalization time
Time frame: during surgery (e.g. up to 1 day)
blood transfusion rate intraoperatively
Time frame: during hospitalization, an average of 7 days
blood transfusion rate postoperatively
Time frame: 6 months
Glasgow Coma Scale
Time frame: 6 months
modified Rankin scale
Time frame: 6 months
Glasgow Outcome Scale
Time frame: 6 months
Markwalder Score
University Hospital, Basel, Switzerland
Other
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
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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