,
Kolias, Angelos G.
Edlmann, Ellie http://orcid.org/0000-0002-7253-9115
Thelin, Eric P.
Bulters, Diederik
Holton, Patrick
Suttner, Nigel
Owusu-Agyemang, Kevin
Al-Tamimi, Yahia Z.
Gatt, Daniel
Thomson, Simon
Anderson, Ian A.
Richards, Oliver
Whitfield, Peter
Gherle, Monica
Caldwell, Karen
Davis-Wilkie, Carol
Tarantino, Silvia
Barton, Garry
Marcus, Hani J.
Chari, Aswin
Brennan, Paul
Belli, Antonio
Bond, Simon
Turner, Carole
Whitehead, Lynne
Wilkinson, Ian
Hutchinson, Peter J.
Funding for this research was provided by:
Health Technology Assessment Programme (13/15/02)
Royal College of Surgeons of England (RCS Rosetrees Research Fellowship)
Svenska Sällskapet för Medicinsk Forskning
National Institute for Health Research (Research Professorship)
Article History
Received: 10 July 2018
Accepted: 12 November 2018
First Online: 4 December 2018
Change Date: 18 March 2019
Change Type: Correction
Change Details: After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled.
Ethics approval and consent to participate
: The Dex-CSDH trial protocol version 3, 27 Apr 2017, informed consent forms and all other relevant trial documents have been approved by North West-Haydock Research and Ethics Committee (REC), reference 15/NW/0171.All correspondence with the REC will be retained in the Trial Master File and Investigator Site File. Annual reports will be submitted to the REC in accordance with national requirements. The trial will be performed in accordance with the SPIRIT guidelines and the letter of the declaration of Helsinki, the conditions and principles of GCP, the protocol and applicable local regulatory requirements and laws.Protocol violations, deviations, non-compliances or breaches are departures from the approved protocol and must be adequately documented and reported to the Chief Investigator and Sponsor immediately. Any potential/suspected serious breaches of GCP must be reported immediately to the sponsor without any delay.
: The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The sponsors and funders reviewed the study design, management and analysis plan before approving the trial. Ownership of the data arising from this trial resides with the trial management group, who will decide on publication and authorship. On completion of the trial, the data will be analysed and tabulated and a final trial report will be prepared.<b>TMG members</b>: Peter J Hutchinson (Chief Investigator), Ellie Edlmann (Trial fellow and trainee Lead Investigator), Eric Thelin (Trial Fellow), Angelos G Kolias (Co-chief Investigator), Karen Caldwell (Research nurse), Silvia Tarantino (Research nurse), Carol Davis-Wilkie (trial coordinator), Carol Turner (Research manager), Simon Bond (Statistician), Beatrice Pantaleo (Data manager).<b>Trial sponsors:</b>Cambridge University Hospitals NHS Foundation Trust, as a member of the NHS Clinical Negligence Scheme for Trusts, will accept full financial liability for harm caused to patients in the clinical trial caused through the negligence of its employees and honorary contract holders. There are no specific arrangements for compensation should a patient be harmed through participation in the trial, but no-one has acted negligently. The University of Cambridge will arrange insurance for negligent harm caused as a result of protocol design and for non-negligent harm arising through participation in the clinical trial.
: The authors declare that they have no competing interests.
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