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.

Trials
|January 23, 2019
PubMed

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.
Abstract

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