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Lookup NU author(s): Philip Kane, Dr Paul Brennan
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2019, The Author(s). 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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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.
Author(s): Edlmann E, Thelin EP, Caldwell K, Turner C, Whitfield P, Bulters D, Holton P, Suttner N, Owusu-Agyemang K, Al-Tamimi YZ, Gatt D, Thomson S, Anderson IA, Richards O, Gherle M, Toman E, Nandi D, Kane P, Pantaleo B, Davis-Wilkie C, Tarantino S, Barton G, Marcus HJ, Chari A, Belli A, Bond S, Gafoor R, Dawson S, Whitehead L, Brennan P, Wilkinson I, Kolias AG, Hutchinson PJA, Badran K, Coulter I, Gallagher MJ, Hogg FRA, Pringle C, Razak A, Soleiman H, Piper R, Vintu M, Wahba A, Wiggins A, Yakoub KM, Zaben M, Zolnourian A, Bodkin P, Cirstea E, Critchley G, Eglinton C, Finlay L, Georgieva D, Gurusinghe N, Haliasos N, Holliman D, Hossain-Ibrahim K, Hussain M, Kandasamy J, Kambafwile M, Nannapaneni R, Ortiz-Ruizde Gordoa L, Papadopoulos MC, Paraskevopoulos D, Patel J, Manjunath Prasad KS, Tzerakis N
Publication type: Article
Publication status: Published
Journal: Scientific Reports
Year: 2019
Volume: 9
Issue: 1
Online publication date: 10/04/2019
Acceptance date: 01/03/2019
Date deposited: 30/04/2019
ISSN (electronic): 2045-2322
Publisher: Nature Publishing Group
URL: https://doi.org/10.1038/s41598-019-42087-z
DOI: 10.1038/s41598-019-42087-z
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