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Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled
Maria Kamenova1, Christian Mueller2, Michael Coslovsky3
1Department of Neurosurgery, University Hospital of Basel, Spitalstrasse 21, 4053 CH, Basel, Switzerland. maria.kamenova@web.de.
Insights
Managing low-dose aspirin (ASA) in chronic subdural hematoma (cSDH) patients undergoing surgery is challenging. This study compares recurrence and cardiovascular risks between continuing ASA versus placebo, aiming to establish evidence-based guidelines for this common clinical question.
Area of Science:
- Neurosurgery
- Cardiology
- Clinical Trials
Background:
- Low-dose aspirin (ASA) use in chronic subdural hematoma (cSDH) presents a neurosurgical dilemma.
- Continuing ASA may increase recurrence and bleeding, while discontinuation risks thromboembolic events.
Purpose of the Study:
- To compare postoperative recurrence and cardiovascular complication rates in cSDH patients undergoing burr-hole trepanation.
- To evaluate the safety and efficacy of perioperative ASA management in cSDH patients.
Main Methods:
- Prospective, randomized, placebo-controlled, double-blinded study.
- Patients undergoing burr-hole drainage for cSDH on ASA treatment were randomized to receive ASA or placebo perioperatively.
- Primary endpoint: rate of recurrent cSDH events.
Main Results:
- Study is registered (NCT03120182) and protocol V2_23.02.2017.
- Secondary objectives include thromboembolic events, blood loss, anemia, and transfusion rates.
Conclusions:
- No current evidence-based consensus exists for managing ASA in cSDH patients undergoing surgery.
- Decision to continue or interrupt ASA is often surgeon preference.
- A randomized placebo-controlled study is urgently needed to provide Class I evidence.
Background:
Low-dose acetylsalicylic acid (ASA) in patients with chronic subdural hematoma (cSDH) represents a significant neurosurgical challenge. While continuation of ASA during the perioperative phase might increase recurrence and bleeding rates, discontinuation increases the risk of thromboembolic events. The aim of this study is to compare the postoperative recurrence and cardiovascular complication rates of patients undergoing burr-hole trepanation for cSDH with and without discontinuation of ASA.
Methods:
In this prospective randomized, placebo-controlled, double-blinded study we include all patients undergoing burr-hole drainage of cSDH who are under ASA treatment. The patients are randomized into two groups, one receiving ASA and the other placebo perioperatively. The study primarily seeks to compare the rate of recurrent events under ASA to that under placebo treatment. Secondary objectives are thromboembolic event rate, perioperative blood loss, postoperative anemia, intra- and postoperative blood transfusion rate, and clinical outcome.
Discussion:
To date, there is no evidence-based consensus on how to manage patients undergoing burr-hole drainage for cSDH who are under ASA treatment. Therefore, the decision to maintain or interrupt ASA treatment is based mostly on the surgeons' preference. A randomized placebo-controlled study for this frequent question is urgently needed in order to provide class I evidence for the best possible treatment of this large group of patients.
Trial Registration:
ClinicalTrials.gov: NCT03120182 . Initial Release: 19.04.2017.
Study Protocol:
V2_23.02.2017.
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