Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase

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Authors

  • Dex-CSDH trial collaborative and BNTRC collaborative

External organisations

  • Division of Neurosurgery, Addenbrooke's Hospital, Box 167, Cambridge, CB2 0QQ, UK. ee291@cam.ac.uk.
  • Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
  • Division of Neurosurgery, Addenbrooke's Hospital, Box 167, Cambridge, CB2 0QQ, UK. ak721@cam.ac.uk.
  • Southwest Neurosurgical Centre, Plymouth University Hospitals NHS trust, Plymouth, PL6 8DH, UK.
  • University Hospital Southampton NHS Foundation Trust
  • Institute of Neurosciences, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, G51 4TF, UK.
  • Department of Neurosurgery, Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.
  • Department of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.
  • University Hospitals Birmingham NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • Department of Neurosurgery, The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK.
  • Cambridge Clinical Trials Unit (CCTU), Coton House, Level 6, Cambridge Biomedical Campus, Box 401, Cambridge, CB2 0QQ, UK.
  • University of East Anglia
  • Barts Health NHS Trust
  • MRC Biostatistics Unit, Robinson Way, Cambridge Biomedical Campus, Cambridge, CB2 0SR, UK.
  • Clinical Trials Pharmacy, Addenbrooke's Hospital, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
  • Department of Clinical Neurosciences, University of Edinburgh, Western General Hospitals NHS Trust, Crewe Road, Edinburgh, EH4 2XU, UK.

Abstract

The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.

Details

Original languageEnglish
Article number5885
Number of pages13
JournalScientific Reports
Volume9
Issue number1
Publication statusPublished - 10 Apr 2019

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