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
Overview
- Phase
- N/A
- Intervention
- Placebo Oral Tablet
- Conditions
- Chronic Subdural Hematoma
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Revision surgery due to a recurrent subdural hematoma
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo Arm
The patients will receive placebo oral tablets for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization
Intervention: Placebo Oral Tablet
Aspirin Arm
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
Intervention: Acetylsalicylic acid
Outcomes
Primary Outcomes
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
- Stroke(6 months)
- Peripheral arterial occlusion(6 months)
- Myocardial infarction(6 months)
- Intraoperative blood loss(on the operation day (up to 1 day))
- Amount of blood/ fluid collected in the drain(up to 2 days, at removal of the drainage)
- Postoperative anemia(up to 7 days)
- Hospitalization time(an average of 7 days)
- Operation time(during surgery)
- Intraoperative blood transfusion rate(during surgery (e.g. up to 1 day))
- Postoperative blood transfusion rate(during hospitalization, an average of 7 days)
- Clinical outcome(6 months)
- Other bleeding events apart from recurrent chronic subdural hematoma managed operatively or conservatively(6 months)
- GCS Score(6 months)
- mRS(6 months)
- GOS(6 months)