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Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial

Desborough, Michael J.R.; Al-Shahi Salman, Rustam; Stanworth, Simon J.; Havard, Diane; Brennan, Paul M.; Dineen, Robert A.; Coats, Tim J.; Hepburn, Trish; Bath, Philip M.; Sprigg, Nikola; DASH trial investigators

Authors

Michael J.R. Desborough

Rustam Al-Shahi Salman

Simon J. Stanworth

Diane Havard

Paul M. Brennan

Tim J. Coats

PHILIP BATH philip.bath@nottingham.ac.uk
Stroke Association Professor of Stroke Medicine

NIKOLA SPRIGG nikola.sprigg@nottingham.ac.uk
Professor of Stroke Medicine

DASH trial investigators



Abstract

Introduction
Intracerebral haemorrhage can be devastating and is a common cause of death and disability worldwide. Pre-intracerebral haemorrhage antiplatelet drug use is associated with a 27% relative increase in one-month case fatality compared to patients not using antithrombotic drugs. We aim to assess the feasibility of conducting a randomised controlled testing the safety and efficacy of desmopressin for patients with antiplatelet-associated intracerebral haemorrhage.

Methods and Analysis
We aim to include 50 patients within 24 hours of spontaneous intracerebral haemorrhage onset, associated with oral antiplatelet drug(s) use in at least the preceding seven days. Patients will be randomised (1:1) to receive intravenous desmopressin 20μg in 50 mls sodium chloride 0.9% infused over 20 minutes or matching placebo. We will mask participants, relatives and outcome assessors to treatment allocation. Feasibility outcomes include proportion of patients approached being randomised, number of patients receiving allocated treatment, rate of recruitment, and adherence to treatment and follow up. Secondary outcomes include change in intracerebral haemorrhage volume at 24 hours; hyponatraemia at 24 hours, length of hospital stay, discharge destination, early death less than 28 days, death or dependency at day 90, death up to day 90, serious adverse events (including thromboembolic events) up to day 90; disability (Barthel index, day 90), quality of life (EuroQol 5D (EQ-5D], day 90), cognition (telephone mini-mental state examination day 90), and health economic assessment (EQ-5D).

Ethics and dissemination
The DASH trial received ethical approval from the East Midlands - Nottingham 2 research ethics committee (18/EM/0184). The DASH trial is funded by NIHR RfPB grant: PB-PG-0816-20011. Trial results will be published in a peer reviewed academic journal and disseminated through academic conferences and through patient stroke support groups. Reporting will be in compliance with CONSORT recommendations.

Citation

Desborough, M. J., Al-Shahi Salman, R., Stanworth, S. J., Havard, D., Brennan, P. M., Dineen, R. A., …DASH trial investigators, . (2020). Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial. BMJ, 10(11), https://doi.org/10.1136/bmjopen-2020-037555+

Journal Article Type Article
Acceptance Date Jul 30, 2020
Online Publication Date Nov 10, 2020
Publication Date 2020-11
Deposit Date Aug 13, 2020
Publicly Available Date Nov 10, 2020
Journal BMJ
Print ISSN 1756-1833
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 10
Issue 11
Article Number e037555
DOI https://doi.org/10.1136/bmjopen-2020-037555+
Public URL https://nottingham-repository.worktribe.com/output/4829460
Publisher URL https://bmjopen.bmj.com/content/10/11/e037555

Files

e037555.full (694 Kb)
PDF

Publisher Licence URL
http://creativecommons.org/licenses/by/4.0/





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