Chronic Subdural Hematoma and Aspirin
- Conditions
- Chronic Subdural Hematoma
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03120182
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Patients undergoing burr hole trepanation for cSDH who are under low-dose aspirin treatment ( Aspirin cardio 100mg once a day) for secondary prophylaxis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Arm Placebo Oral Tablet The patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization Aspirin Arm Acetylsalicylic acid 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
- Primary Outcome Measures
Name Time Method Revision surgery due to a recurrent subdural hematoma 6 months Recurrence of chronic subdural hematoma requiring revision surgery (burr-hole drainage)
- Secondary Outcome Measures
Name Time Method Clinical outcome 6 months Markwalder Score
Stroke 6 months cerebral stroke
Peripheral arterial occlusion 6 months occlusion of a peripheral artery
Myocardial infarction 6 months (STEMI/non-STEMI)
Intraoperative blood loss on the operation day (up to 1 day) blood loss recorded during surgery
Amount of blood/ fluid collected in the drain up to 2 days, at removal of the drainage Amount of blood/ fluid collected in the drain
Postoperative anemia up to 7 days hemoglobin\<80mg/L
Hospitalization time an average of 7 days Hospitalization time
Operation time during surgery Operation time
Intraoperative blood transfusion rate during surgery (e.g. up to 1 day) blood transfusion rate intraoperatively
Postoperative blood transfusion rate during hospitalization, an average of 7 days blood transfusion rate postoperatively
Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively 6 months acute subdural hematoma (aSDH), acute epidural hematoma (EDH), intraparenchymal bleeding)
GCS Score 6 months Glasgow Coma Scale
mRS 6 months modified Rankin scale
GOS 6 months Glasgow Outcome Scale
Trial Locations
- Locations (1)
Department of Neurosurgery
🇨ðŸ‡Basel, Switzerland