Desmopressin for reversal of
For further information please contact us.
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)|
|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 either desmopressin or placebo to inform a definitive trial.|
|Trial configuration||A phase II double blind randomised placebo controlled feasibility trial|
|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|
|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||
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.|
|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.|
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.
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|
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