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    Summary
    EudraCT Number:2015-002661-36
    Sponsor's Protocol Code Number:15039DB-SW
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-04
    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 number2015-002661-36
    A.3Full title of the trial
    Single centre randomised controlled trial to assess the effect of the addition of twenty-four hours of oral tranexamic acid post-operatively to a single intra-operative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee arthroplasty.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of tranexamic acid on blood loss for total joint replacement
    A.3.2Name or abbreviated title of the trial where available
    Influence of tranexamic acid on blood loss in total joint replacement
    A.4.1Sponsor's protocol code number15039DB-SW
    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 SponsorBelfast Health and Social Care Trust
    B.1.3.4Country
    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 supportBelfast Arthroplasty Research Trust (Charity Ref XR 45641)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBelfast HSC Trust
    B.5.2Functional name of contact pointDavid Beverland
    B.5.3 Address:
    B.5.3.1Street AddressOutcomes Assessment Unit
    B.5.3.2Town/ cityMusgrave Park Hospital
    B.5.3.3Post codeBT9 7JB
    B.5.4Telephone number07736679869
    B.5.6E-maildavid.beverland@belfasttrust.hscni.net
    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 Information not present in EudraCT
    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 nameTranexamic acid
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTranexamic Acid
    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 number500
    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.IMP: 2
    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 Information not present in EudraCT
    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 nameTranexamic Acid
    D.3.4Pharmaceutical form Solution for injection
    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 INNTranexamic Acid
    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.3.10.3Concentration number100
    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
    Osteoarthritic patients who require hip or knee arthroplasty
    E.1.1.1Medical condition in easily understood language
    Patients requiring a hip or knee replacement
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    The primary objective is to determine if the use of oral tranexamic acid post-operatively for up to 24h hours will confer a reduction in calculated blood loss at 48 hours beyond an intra-operative intravenous bolus alone for patients undergoing unilateral primary total hip or knee replacement.
    E.2.2Secondary objectives of the trial
    To determine whether there is any difference between each of the three groups in the study for the following parameters:
    • Incidence of post-operative haemoglobin falling below the transfusion trigger (irrespective of whether or not the patient was transfusion) prior to discharge
    • Effect of body mass index (BMI) on the volume of indirect blood loss at 48 hours post-surgery
    • Change in c-reactive protein from pre-surgery to 48 hours post-surgery
    • Change in creatinine level from pre-surgery to 48 hours post-surgery
    • 90 day mortality
    • 1 year mortality
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients awaiting primary elective hip or knee replacement in the Primary Joint Unit at Musgrave Park Hospital.
    2. Patients greater than or equal to 18 years of age.
    E.4Principal exclusion criteria
    1.Patients who do not pass a pre-operative assessment for elective total hip or knee arthroplasty (THA/TKA)
    2.Fractured neck of femur
    3.Haemophiliac or coagulation disorders that require TXA
    4.Allergy to tranexamic acid or any of its excipients
    5.Platelets less than 75,000/mm3 at pre-operative assessment*
    6.Patients on active treatment for venous thromboembolism (VTE) (deep vein thrombosis (DVT), pulmonary embolisms (PE)) within 6 months of surgery*
    7.History of VTE within 6 months of surgery*
    8.Patients who have had a myocardial infarction (MI) within 12 months*
    9.Cardiac stent within 12 months of surgery*
    10.Patients who have had a stroke (cerebrovascular accident (CVA)) or transient ischemic attack (TIA) within 9 months of surgery*
    11.Anticoagulant use within 7 days of surgery (thienopyridines, clopidogrel etc.*
    12.Direct thrombin inhibitors within 2 days of surgery*
    13.Xa inhibitors within 2 weeks of surgery*
    14.Patients who have stopped Warfarin in preparation for surgery but have an INR level greater than or equal to 1.5*
    15.Hepatic failure*
    16.Patients with epilepsy
    17.Patients requiring therapeutic anticoagulation post-operatively eg. metallic heart valves.
    18.Pregnant women, women who have not yet reached the menopause (no menses for ≥ 12 months without an alternative medical cause) who test positive for pregnancy, are unwilling to take a pregnancy test prior to trial entry
    19.Patients who have taken the combined oral contraceptive pill within 4 weeks of surgery*
    20.Female patients who are breastfeeding
    21.Treated with any other investigational medication or device within 60 days
    22.Patients unable to provide informed consent
    23.Patients who are unable or unwilling to commit to the study schedule of events

    *These are patients with contra-indications to primary hip or knee replacement.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is total indirect blood loss volume in millilitres at 48 hours. This is calculated from the following parameters:

    Height (m)
    Weight (kg)
    Patient sex
    Pre-operative haematocrit
    Post-operative haematocrit at 48 hours
    Volume of blood transfused
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours following knife to skin at the start of a patient's hip or knee replacement.
    E.5.2Secondary end point(s)
    •Incidence of post-operative haemoglobin falling below the transfusion trigger before discharge irrespective of whether or not the patient was transfused
    •Effect of body mass index on volume of indirect blood loss at 48 hours post-surgery
    •Change in c-reactive protein from pre-surgery to 48 hours post-surgery
    •Change in creatinine level from pre-surgery to 48 hours post-surgery
    •90 day mortality
    •1 year mortality
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours post knife to skin: Effect of body mass index on percentage of blood loss, change in c-reactive protein from pre-operative levels, change in creatinine level from pre-operative levels,

    Discharge from hospital: Incidence of post-operative haemoglobin falling below the transfusion trigger

    90 days post surgery: mortality

    1 year post surgery: mortality
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard care (no intervention)
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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 purposes of submitting the end of trial notification to the Sponsor, MHRA and REC the end of trial will be considered to be when database lock occurs for the final analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days31
    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: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 583
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 583
    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 state1166
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1166
    F.4.2.2In the whole clinical trial 1166
    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)
    Participants will be receiving this intervention as part of their hip or knee replacement therefore this would only apply were they to have an additional hip or knee replaced. When the study ends the intervention will only be provided should a change in hospital policy on tranexamic acid be made or if they are considered to be at high risk of bleeding (patients with blood disorders such as haemophilia or with rapidly progressing osteoarthritis).
    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 Decision2016-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-06
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    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
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