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    Summary
    EudraCT Number:2015-001401-13
    Sponsor's Protocol Code Number:RRK5174
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-12-18
    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 number2015-001401-13
    A.3Full title of the trial
    A Multi-Centre Randomised Controlled Trial of Pre-Hospital Blood Product Administration versus Standard Care for Traumatic Haemorrhage
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-centre randomised controlled trial of pre-hospital administration of packed red blood cells and freeze-dried plasma to patients with low blood pressure after major injuries.
    A.3.2Name or abbreviated title of the trial where available
    RePHILL (Resuscitation with Pre-HospItaL bLood products)
    A.4.1Sponsor's protocol code numberRRK5174
    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 Hospitals Birmingham NHS Foundation Trust
    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 supportNational Institute for Healthcare Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSurgical Reconstruction and Microbiology Research Centre
    B.5.2Functional name of contact pointProfessor Mark Midwinter
    B.5.3 Address:
    B.5.3.1Street AddressMindelsohn Way
    B.5.3.2Town/ cityEdgbaston, Birmingham
    B.5.3.3Post codeB15 2GW
    B.5.4Telephone number07718863967
    B.5.6E-mailmark.midwinter@uhb.nhs.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 LyoPlas N - w
    D.2.1.1.2Name of the Marketing Authorisation holderDeutsche Rote Kreuz - Blutspendedienst West
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameLyoPlas N-w
    D.3.2Product code Lyophilised Plasma LyoPlas N-w (blood group AB)
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCoagulable human plasma
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive nameLyoPlas N-w
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.5The 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 nameSodium Chloride 0.9% (Normal Saline)
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Chloride 0.9%
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive nameSodium Chloride 0.9% Intravenous Infusion BP
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hypotension after trauma, due to haemorrhage
    E.1.1.1Medical condition in easily understood language
    Very low blood pressure as a result of rapid bleeding due to injuries
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10053476
    E.1.2Term Traumatic haemorrhage
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compared to the current standard of care, does resuscitation with blood products improve the quality of resuscitation (measured by venous lactate clearance during the first two hours from randomisation and reduce mortality in trauma patients?
    E.2.2Secondary objectives of the trial
    a. Compared to standard care, does pre-hospital blood product resuscitation:
    i. improve blood pressure, heart rate and capillary oxygenation on ED arrival?
    ii. prolong on-scene time?
    iii. reduce pre-hospital fluid requirements?
    iv. reduce in-hospital transfusion requirements?
    v. reduce trauma-induced coagulopathy?
    vi. preserve platelet function?
    vii.reduce deaths within three hours of hospital arrival
    viii.lead to a greater incidence of transfusion-related complications, particularly acute respiratory distress syndrome?
    ix.lead to blood product wastage?

    b. Are outcomes influenced by:
    i. blunt vs. penetrating injury mechanism?
    ii. destination?
    iii. transport mode?
    iv. lactate on ED arrival?
    v. ED arrival within one hour of injury?
    vi. total pre-hospital fluid volume?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    a. Traumatic injury
    b. Pre-Hospital Emergency Medical team attend
    c. Hypotension (SBP <90mmHg or absence of palpable radial pulse) believed to be due to traumatic haemorrhage.
    E.4Principal exclusion criteria
    a. Children (known or apparently aged <16 years)
    b. Refusal of blood product administration; known Jehovah’s Witness
    c. Pregnancy (known or apparent)
    d. Isolated head injury
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is a composite consisting of episode mortality (from point of recruitment to discharge from initial hospital admission or death) and lactate clearance <20%/hr in the first two hours from randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Components:
    1) Initial lactate clearance: 2h after admission to the Emergency Department (ED)
    2) Episode mortality: at time of death or discharge from initial hospital admission
    E.5.2Secondary end point(s)
    1) individual components of primary outcome
    2) pre-hospital time
    3) pre-hospital fluid type and volume
    4) on Emergency Department arrival:
    a) vital signs (systolic blood pressure, heart rate, capillary oxygen saturation)
    b) venous lactate concentration
    c) coagulation (measured viscoelastically with rotational thromboelastometery)
    d) coagulation (INR)
    e) platelet function (MultiPlate)
    5) total blood product receipt at specified time points
    6) during initial admission, incidence of:
    a) acute respiratory distress syndrome
    b) transfusion-related complications
    c) organ failure-free days
    d) mortality at 6 & 24 hours, 7 days and initial hospital admission
    7) pre-hospital blood product wastage
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) As per B1-23-1
    2) ED arrival
    3) ED arrival
    4) (all) ED arrival
    4) d) also at 2 and 6 hours after ED arrival
    5) 2, 6, 12 and 24 hours from ED arrival
    6) (all) at time of death or discharge from initial hospital admission
    7) Conclusion of study
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Researchers and participants blinded to allocation until after recruitment into trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned15
    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
    For the recruited participants their participation ends at death, hospital discharge or at 30 days follow‐up, whichever occurs first. The end of trial will be 30 days after the last data capture.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 45
    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: 45
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 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
    Trauma patients incapacitated due to injuries
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state490
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 490
    F.4.2.2In the whole clinical trial 490
    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)
    Not applicable - the trial intervention is only relevant to the pre-hospital environment. From the point of arrival in hospital, the participants will be treated in accordance with the direction of the doctors under whose care they are admitted.
    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 Decision2016-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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