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    Clinical Trial Results:
    Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH)

    Summary
    EudraCT number
    		 2018-001904-12
    Trial protocol
    		 GB  
    Global end of trial date
    09 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2023
    First version publication date
    08 Jul 2023
    Other versions
    Summary report(s)
    		 DASH RfPB final report
    DASH protocol paper
    Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    18040
    Additional study identifiers
    ISRCTN number
    		 ISRCTN67038373
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Queens Medical School Campus, Nottingham, United Kingdom, NG7 2UH
    Public contact
    Sprigg, University of Nottingham, 44 115 82 31765, nikola.sprigg@nottingham.ac.uk
    Scientific contact
    Sprigg, University of Nottingham, 44 115 82 31765, nikola.sprigg@nottingham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jun 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the feasibility of randomising, administering the intervention, and completing follow-up for patients treated with desmopressin or placebo to inform a definitive trial.
    Protection of trial subjects
    An independent data monitoring committee reviewed the data during the trial.
    Background therapy
    		 Standard care for ICH as per local clinical guidelines
    Evidence for comparator
    		 Placebo (saline) is comparator
    Actual start date of recruitment
    01 Aug 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    11
    From 65 to 84 years
    33
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from ten acute stroke centres in the United Kingdom. Participants were included if they met all the inclusion criteria and none of the exclusion criteria.

    Pre-assignment
    Screening details
    		 Patients with acute stroke due to ICH screen by site staff

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All blinded to allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Control (saline)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Injection
    Dosage and administration details
    Saline

    Arm title
    		 Desmopressin
    Arm description
    		 Desmopressin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desmopressin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Tbc

    Number of subjects in period 1
    		Placebo Desmopressin
    Started
    27
    27
    Completed
    27
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Control (saline)

    Reporting group title
    Desmopressin
    Reporting group description
    		 Desmopressin

    Reporting group values
    		 Placebo Desmopressin Total
    Number of subjects
    		 27 27 54
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 6 5 11
        From 65-84 years
    		 17 16 33
        85 years and over
    		 4 6 10
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 7 11 18
        Male
    		 20 16 36

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Control (saline)

    Reporting group title
    Desmopressin
    Reporting group description
    		 Desmopressin

    Primary: modified rankin day 90 dichotomy

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    End point title
    		 modified rankin day 90 dichotomy [1]
    End point description
    mRS > 4
    End point type
    Primary
    End point timeframe
    day 90
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Feasibility trial so no formal statistical analysis was carried out
    End point values
    		 Placebo Desmopressin
    Number of subjects analysed
    27
    27
    Units: dead or severly dependent
        mRS>4
    10
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    90 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Control (saline)

    Reporting group title
    Desmopressin
    Reporting group description
    		 Desmopressin

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non SAE's were not collecected as per protocol
    Serious adverse events
    		 Placebo Desmopressin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 27 (48.15%)
    12 / 27 (44.44%)
         number of deaths (all causes)
    7
    5
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    All SAEs
         subjects affected / exposed
    13 / 27 (48.15%)
    12 / 27 (44.44%)
         occurrences causally related to treatment / all
    1 / 22
    3 / 16
         deaths causally related to treatment / all
    0 / 7
    0 / 5
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Desmopressin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 27 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Nov 2019
    SA/03/19, 22/11/2019, participants could be recruited if they could be randomised within 24 hours from onset of symptoms.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This was a feasibility trial that took place in the COVID 19 pandemic. No statistical comparisons were performed due to lack of power, as per protocol. Full report is available in the End of Trial Funder Report - see attached. Paper to be uploaded
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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