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Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department : study protocol
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Carlton, Edward, Campbell, Sarah, Ingram, Jenny, Kandiyali, Rebecca, Taylor, Hazel, Aziz, Shahid, Beresford, Peter, Kendall, Jason, Reuben, Adam, Smith, Jason, Vickery, Patricia Jane and Benger, Jonathan Richard (2018) Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department : study protocol. BMJ Open, 8 (10). e025339. doi:10.1136/bmjopen-2018-025339 ISSN 2044-6055.
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Official URL: http://dx.doi.org/10.1136/bmjopen-2018-025339
Abstract
Introduction: Observational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%–60% of ED patients with chest pain. This is done using an ‘undetectable’ cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients.
Methods and analysis: This is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate.
Item Type: | Journal Article | ||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | BMJ Open | ||||||
Publisher: | BMJ | ||||||
ISSN: | 2044-6055 | ||||||
Official Date: | 2 October 2018 | ||||||
Dates: |
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Volume: | 8 | ||||||
Number: | 10 | ||||||
Article Number: | e025339 | ||||||
DOI: | 10.1136/bmjopen-2018-025339 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Open Access (Creative Commons) |
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