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    The EU Clinical Trials Register currently displays   37221   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-003284-62
    Sponsor's Protocol Code Number:012508
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-05
    Trial 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 number2018-003284-62
    A.3Full title of the trial
    A randomised, blinded, placebo controlled, Phase 2a study to evaluate the safety and efficacy of administering Regadenoson to patients with critical injury and signs of haemorrhagic shock
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rescue with Regadenoson (ReWiRe)
    A.3.2Name or abbreviated title of the trial where available
    Rescue With Regadenoson (ReWiRe)
    A.4.1Sponsor's protocol code number012508
    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 SponsorQueen Mary University London
    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 supportBart's Charity
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportJ P Moulton Charitable Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueen Mary University London
    B.5.2Functional name of contact pointDr Mays Jawad
    B.5.3 Address:
    B.5.3.1Street Address5 Walden Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeE1 2EF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 7882 7275
    B.5.6E-mailresearch.governance@qmul.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 Rapiscan
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare AS
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameRapiscan
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRegadenoson
    D.3.9.1CAS number 313348-27-5
    D.3.9.3Other descriptive namesynthetic A2A adenoreceptor agonist
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6 to 2.4
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cardiovascular collapse following traumatic haemorrhage
    E.1.1.1Medical condition in easily understood language
    Heart failure caused by major bleeding after injury
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Regadenoson is a medicine that dilates blood vessels within the muscle of the heart, and is currently used to enable doctors to visualise the blood supply to heart tissue. The drug works by stimulating a particular type of receptor found in the heart and blood vessels. In addition to dilating blood vessels and improving blood flow, this particular receptor is also thought to protect cells that are not receiving enough oxygen, such as in the case of severe bleeding following injury. Our research team have a developed an animal model that recreates severe bleeding in trauma. Using this model, we have demonstrated that Regadenoson improves the function of the heart, reduces the severity of shock (reduced blood flow), and lowers the amount of fluid needed in resuscitation. We now wish to carry out a Phase 2a study to test whether the use of Regadenoson in severely injured, bleeding trauma patients can provide similar benefits to patient outcomes.

    We wish to determine whether Regadenoson
    E.2.2Secondary objectives of the trial
    In addition to the above, we wish to explore the following:
    • Change in lactate from baseline to 2 hours post-dosing
    • h-FABP level on admission and 24 hours (+/- 12-hours)
    • 24-hour fluid and transfusion requirements
    • Lactate level at admission and 24 hours post-admission
    • Blood pressure on admission
    • MAP on admission
    • Difference between lowest SBP PH and admission SBP
    • Number of ACEs (defined as rhythm or, ECG changes when noted by clinical team).
    • Daily SOFA score for days 1 to 7
    • Daily CTCOFR for days 1 to 7
    • Total number of vasopressor/inotrope days including vasopressor/inotrope type and dose up to day 28, discharge, or death
    • Total length of hospital stay up to day 28, discharge, or death
    • GOS-E at discharge
    • Total length of critical care stay up to day 28, discharge, or death
    • Mortality (2-hour, 24-hour, discharge/28-day whichever is sooner)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male
    • Deemed to be aged ≥18 and ≤70 years
    • Activated pre-hospital code-red criteria (activation criteria are: systolic blood pressure <90 mmHg, AND suspected haemorrhage).
    • Started transfusion of at least 1 unit of PRBCs (or blood component equivalent)
    • Is intubated and ventilated
    • Patient has suffered a traumatic injury
    • Is able to be randomised within 1 hour of the pre-hospital physician arriving at the scene of the injury

    E.4Principal exclusion criteria
    • Patient suffered a traumatic cardiac arrest prior to screening
    • Patients who are suspected to have shock due a non-haemorrhagic cause, as assessed by the pre-hospital care team
    • Time of IMP/Placebo administration not attainable prior to admission to the receiving hospital
    • Presence of obvious catastrophic traumatic brain injury or other non-survivable injury, diagnosed by the pre-hospital team
    • Known or suspected pre-injury cardiac disease
    • Known allergy to regadenoson

    E.5 End points
    E.5.1Primary end point(s)
    Blood lactate level 2 hours post IMP administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 hours post IMP dosing.
    E.5.2Secondary end point(s)
    • Change in lactate from baseline to 2 hours post-dosing
    • h-FABP level on admission and 24 hours (+/- 12-hours)
    • 24-hour fluid and transfusion requirements
    • Lactate level at admission and 24 hours post-admission
    • Blood pressure and MAP on admission
    • Difference between lowest SBP PH and admission SBP
    • Number of ACEs (defined as rhythm, ECG changes when noted by clinical team).
    • SOFA score for days 1 to 7
    • CTCOFR for days 1 to 7
    • Total number of vasopressor/inotrope days including vasopressor/inotrope type and dose
    • Total length of hospital stay.
    • GOS-E at discharge
    • Total length of critical care stay.
    • Mortality (24-hour, discharge/28-day whichever is sooner).
    E.5.2.1Timepoint(s) of evaluation of this end point
    as above
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    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.8.3 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 concerned4
    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
    The end of study definition is when 98 completed (received the intervention, reach the primary endpoint, 2 hours and not actively withdrawn) participants have been recruited, all surviving participants have completed 28-day mortality check and all samples have been analysed.
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adult male trauma patients incapacitated as a result of injury and/or their acute medical care
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state98
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 98
    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)
    There are no arrangements for continued provision of the intervention once the research is finished. The investigational medicinal product is given as a single bolus dose upon enrollment in the trial, and no further doses will be dispensed thereafter. The patient will be monitored for 28 days or until discharge.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-18
    P. End of Trial
    P.End of Trial StatusOngoing
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