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

Edlmann, Ellie and Thelin, Eric P and Caldwell, Karen and Turner, Carole and Whitfield, Peter and Bulters, Diederik and Holton, Patrick and Suttner, Nigel and Owusu-Agyemang, Kevin and Al-Tamimi, Yahia Z and Gatt, Daniel and Thomson, Simon and Anderson, Ian A and Richards, Oliver and Gherle, Monica and Toman, Emma and Nandi, Dipankar and Kane, Phillip and Pantaleo, Beatrice and Davis-Wilkie, Carol and Tarantino, Silvia and Barton, Garry and Marcus, Hani J and Chari, Aswin and Belli, Antonio and Bond, Simon and Gafoor, Rafael and Dawson, Sarah and Whitehead, Lynne and Brennan, Paul and Wilkinson, Ian and Kolias, Angelos G and Hutchinson, Peter J A (2019) Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase. Scientific reports, 9 (1). p. 5885. ISSN 2045-2322. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

[img]
Preview
Text (PDF file format)
Scientific Reports.pdf - Published Version
Available under License Creative Commons Attribution 4.0.

Download (1MB) | Preview
Official URL: https://www.nature.com/articles/s41598-019-42087-z...

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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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.

Item Type: Article
Additional Information: This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects: WL Nervous system. Neurology
Divisions: Emergency Services > Neurology
Related URLs:
Depositing User: Mrs Yolande Brookes
Date Deposited: 12 Apr 2019 13:08
Last Modified: 12 Apr 2019 13:08
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/2015

Actions (login required)

View Item View Item