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Lessons learned from a failed clinical trial of chronic subdural hematoma treatment
  1. Daniel Raper1,
  2. Dale Ding2,
  3. Robert M Starke3
  1. 1 Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA
  2. 2 Department of Neurosurgery, University of Louisville, Louisville, Kentucky, USA
  3. 3 Department of Neurological Surgery, University of Miami Miller School of Medicine, Miami, Florida, USA
  1. Correspondence to Dr Daniel Raper, Department of Neurological Surgery, Houston, Texas, USA; daniel.raper{at}bcm.edu

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To the Editor

We read with interest the Editor’s column in the April 2021 issue of Journal of NeuroInterventional Surgery, titled “Embolization of the middle meningeal artery for the treatment of chronic subdural hematoma: considerations for pragmatic trial design”, which discusses the challenges in rigorously evaluating the efficacy of middle meningeal artery (MMA) embolization for chronic subdural hematomas (cSDH).1 The practical considerations raised by the authors clearly highlight the complexities of designing a clinical trial comparing interventions that can guide practice in what is an unexpectedly heterogeneous population. During our residency training, we devised and attempted to perform a randomized, controlled trial comparing standard burr hole evacuation vs medical therapy (dexamethasone) for cSDH treatment, under the guidance of the late neurosurgeon-scientist Dr. Edward Oldfield.2 The trial ultimately failed to recruit enough patients, but our experience mirrored many of the pitfalls described in the current editorial. As such, our experience might provide some insight for those contemplating clinical trials of MMA embolization in a similar population.

First, …

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Footnotes

  • Twitter @Starke_neurosurgery

  • Contributors DR conceived and drafted the manuscript. DD critically reviewed and edited the manuscript. RMS critically reviewed and edited the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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