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DASH trial - Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage

For further information please contact us.
 
Trial manager: Diane Havard
Chief investigator: Dr Michael Desborough
Nottingham stroke trials office:

    Telephone: +44 (0)115 823 1770     Fax: +44 (0)115 823 1771

Live database

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Demonstration database

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Password nottingham
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In the event that the UK leaves the European Union without a deal (a so-called 'no deal' scenario), UK law remains in place and will do so throughout the trial.

We already have the IMP/placebo supplies and they were not imported from the EU.  We do not expect any issues for the trial in terms of routes for permissions from the MHRA and/or study report upload to the MHRA.

Title Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH)
Acronym DASH
Chief investigator Dr Michael Desborough
Objectives To assess the feasibility of screening, checking the eligibility, approaching, randomising, administering the intervention, and completing follow-up for patients treated with desmopressin or placebo to inform a definitive trial.
Trial configuration A phase II double blind randomised placebo controlled feasibility trial
Setting Secondary care
Sample size estimate This is a feasibility study so there is no formal sample size calculation.  It is likely that a large definitive trial would be feasible if at least 50 participants were recruited into this study, that adherence to study drug was high and that a high proportion of follow-up data was available.  Lower recruitment would not preclude progression if there was some evidence that the barriers to recruitment identified could be overcome.
Number of participants 50
Eligibility criteria Inclusions
  • Adults (at least 18 years old) with confirmed intracerebral haemorrhage on imaging
  • Event less than 12 hours from onset of symptoms, or from when last seen free of stroke symptoms (for sleep stroke, take onset as bed time)
  • Prescribed and thought to be taking a daily oral antiplatelet drug in the preceding seven days – Aspirin, Dipyridamole, Clopidogrel, Prasugrel (Efient®) and/or Ticagrelor (Brilique®).
Exclusions
  • Aneurysmal subarachnoid haemorrhage known at time of randomisation
  • Haemorrhage suspected to be due to transformation of ischaemic stroke or trauma
  • Haemorrhage known to be due to thrombolytic drug or venous thrombosis
  • Risk(s) of fluid retention associated with desmopressin judged clinically significant by the attending physician (for example patients with pulmonary oedema and/or cardiac failure)
  • Significant hypotension (systolic blood pressure under 90 mmHg)
  • Known drug-eluting coronary artery stent in previous three months
  • Allergy to desmopressin
  • Pregnant or breastfeeding
  • Life expectancy less than four hours, or planned for palliative care only
  • Severe pre-morbid disability (modified Rankin scale is 5)
  • Glasgow coma scale less than 5
  • Geographical or other factors that prohibit follow-up at 90 days, e.g. no fixed address or telephone contact number, or overseas visitor
Description of interventions Intravenous desmopressin: 20µg in 50 mls Sodium Chloride 0.9% infused over 20 minutes.
Comparator – placebo (Sodium Chloride 0.9% intravenous infusion) administered by identical regimen.
Duration of study 12 months.
Participants will be followed up for 90 days.
Randomisation and blinding Patients will be randomised (1:1) to receive either desmopressin or matching placebo (Sodium Chloride 0.9%) via intravenous injection.  Randomisation will be performed by the Stroke Trials Unit (STU) and involve computerised minimisation on key prognostic factors: age; sex; time since onset; systolic blood pressure; and presence of intraventricular haemorrhage.  Patients, relatives, researchers and outcome assessors will be masked to treatment allocation.
Outcome measures Feasibility outcomes:
  • Number of eligible patients who receive allocated treatment
  • Rate of eligible patients randomised
  • Proportion of eligible patients approached
  • Proportion of eligible patients randomised and reasons for non-randomisation
  • Adherence to intervention
  • Proportion of participants followed up to 90 days and reasons for loss to follow-up
  • Proportion of randomised participants with full outcome data available, and reasons for non-availability
Secondary clinical outcomes:
  • Hyponatraemia at 24 hours
  • Early case fatality <28 days
  • Case fatality at day 90
  • Serious adverse events (including thromboembolic events) up to day 90
  • Change in intracerebral haemorrhage volume at 24 hours
  • Discharge destination
  • Disability (Barthel index, day 90)
  • Quality of life (EuroQol, day 90)
  • Cognition (telephone MMSE day 90)
  • Length of hospital stay
  • Health economic assessment (EQ-5D)
  • Assessment of baseline platelet dysfunction (P-selectin) and correlation with response to desmopressin
  • Change in factor VIII, VWF antigen and VWF activity, one hour after administration of desmopressin
Statistical methods This is a feasibility trial and the main analysis will be with descriptive statistics only.  Counts will be summarised using N and %, and continuous variables will be summarised using means and standard deviations or medians and interquartile ranges depending on their distribution.  Whilst some variables will be summarised by treatment group, no formal statistical comparisons will be made and any analyses will be considered purely exploratory.



Use of your personal data in research - information for participants

For information about how we use your personal data for DASH in accordance with UK data protection laws, please refer to our data protection supplementary information document.




Contact details
Address: Stroke, Division of Clinical Neuroscience,
University of Nottingham
Clinical Sciences Building, North Road
City Hospital Campus, off Hucknall Road
Nottingham NG5 1PB, United Kingdom
Telephone:0115 823 1770
Fax:0115 823 1771
Email: DASH
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