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    Summary
    EudraCT Number:2018-001904-12
    Sponsor's Protocol Code Number:18040
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2019-11-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-001904-12
    A.3Full title of the trial
    Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to assess whether desmopressin could reduce risk of death or disability for patients with intracerebral haemorrhage (bleeding into the brain) taking antiplatelet (blood thinning ) drugs.
    study will be modified Rankin scale at day 90 (shift analysis).
    A.3.2Name or abbreviated title of the trial where available
    Desmopressin for treatment of stroke patients on antiplatelet therapy
    A.4.1Sponsor's protocol code number18040
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Nottingham
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Nottingham
    B.5.2Functional name of contact pointSprigg
    B.5.3 Address:
    B.5.3.1Street AddressDivision of Clinical Neurosciences, Clinical Sciences Building,
    B.5.3.2Town/ cityNottingham City Hospital Campus
    B.5.3.3Post codeNG5 1PB
    B.5.4Telephone number44(0)115 82 31765
    B.5.5Fax number44(0)115 82 31771
    B.5.6E-mailnikola.sprigg@nottingham.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Desmopressin
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDesmopressin
    D.3.2Product code PL 03194/000
    D.3.4Pharmaceutical form Anticoagulant and preservative solution for blood
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDesmopressin Acetate
    D.3.9.1CAS number 16679-58-6
    D.3.9.2Current sponsor code18040
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Intracerebral haemorrhage
    E.1.1.1Medical condition in easily understood language
    Bleeding into the brain (stroke)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10019016
    E.1.2Term Haemorrhagic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    To assess the effect of desmopressin on secondary outcomes:
    clinical outcomes, safety outcomes, laboratory outcomes, costs and radiological efficacy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults (>16 years)
    Confirmed intracerebral haemorrhage on imaging
    Less than 12 hours from onset of symptoms [or from when last seen healthy]
    Prescribed and thought to be taking a daily oral antiplatelet drug in the preceding seven days (cyclooxygenase inhibitors, phosphodiesterase inhibitors or P2Y12 inhibitors)
    Signed consent (patient/personal/professional representative)
    E.4Principal exclusion criteria
    Aneurysmal subarachnoid haemorrhage known at time of enrolment
    Haemorrhage known to be due to transformation of infarction
    Haemorrhage known to be due to thrombolytic drug
    Haemorrhage known to be due to 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 <90mmHg)
    Known drug-eluting coronary artery stent in previous three months
    Allergy to desmopressin
    Pregnant or breast-feeding
    Life expectancy less than four hours, or planned for palliative care only
    Glasgow coma scale less than 5
    mRS >4
    Participation in another concurrent drug trial
    E.5 End points
    E.5.1Primary end point(s)
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At end of trial
    E.5.2Secondary end point(s)
    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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    I hour: assessment of baseline platelet dysfunction (P-selectin) and correlation with response to desmopressin; change in factor VIII, VWF antigen and VWF activity
    24 hours: Hyponatraemia, Change in intracerebral haemorrhage volume
    28 days: Early mortality
    Day 90 (up to and including):
    Mortality
    Serious adverse events (including thromboembolic events)
    Compliance with intervention
    Disability (Barthel index), Quality of life (EuroQol), Health economic assessment (EQ-5D), Cognition (telephone MMSE)
    Proportion of eligible patients randomised and reasons for non-randomisation
    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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The treatment is administered in a single day and does not require further administration
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NIHR CRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-07
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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