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Protocol
Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double-blind randomised controlled feasibility trial
  1. Michael J R Desborough1,
  2. Rustam Al-Shahi Salman2,
  3. Simon J Stanworth3,4,5,
  4. Diane Havard6,7,
  5. Paul M Brennan2,
  6. Robert A Dineen6,7,
  7. Timothy J Coats8,
  8. Trish Hepburn9,
  9. Philip M Bath6,7,
  10. Nikola Sprigg6,7
  1. 1Haemostasis and Thrombosis Centre, St Thomas’ Hospital, London, UK
  2. 2Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
  3. 3Transfusion Medicine, NHS Blood and Transplant, Oxford, UK
  4. 4Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
  5. 5Radcliffe Department of Medicine, University of Oxford and NIHR Oxford Biomedical Research Centre, Oxford, UK
  6. 6Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK
  7. 7Nottignham University Hospitals NHS Trust, Nottingham, UK
  8. 8Department of Cardiovascular Sciences, University of Leicester, Leicester, UK
  9. 9Clinical Trials Unit, University of Nottingham, Nottingham, UK
  1. Correspondence to Dr Nikola Sprigg; nikola.sprigg{at}nottingham.ac.uk

Abstract

Introduction Intracerebral haemorrhage (ICH) can be devastating and is a common cause of death and disability worldwide. Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with 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 ICH.

Methods and analysis We aim to include 50 patients within 24 hours of spontaneous ICH onset, associated with oral antiplatelet drug(s) use in at least the preceding 7 days. Patients will be randomised (1:1) to receive intravenous desmopressin 20 µg in 50 mL sodium chloride 0.9% infused over 20 min 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 ICH 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 Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH) trial received ethical approval from the East Midlands—Nottingham 2 research ethics committee (18/EM/0184). The DASH trial is funded by National Institute for Health and Care Research 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 Consolidated Standards of Reporting Trials recommendations.

Trial registration numbers NCT03696121; ISRCTN67038373; EudraCT 2018-001904-12.

  • stroke medicine
  • bleeding disorders & coagulopathies
  • anticoagulation
  • stroke
  • clinical trials
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Footnotes

  • Contributors MJRD, SJS, RA-SS and NS conceived the ideas for the study. MJRD wrote the first draft of the protocol with RA-SS, SJS and NS. DH wrote the sections on trial regulation. TH wrote the statistical analysis plan. PMB, RAD, TJC and PMB critically reviewed the protocol and provided expert input.

  • Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0816-20011). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The trial sponsor and funders have no role in the; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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