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    Summary
    EudraCT Number:2020-005592-12
    Sponsor's Protocol Code Number:76873
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-03-11
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-005592-12
    A.3Full title of the trial
    The effect of tranexamic acid on seroma formation after mastectomies
    Tranexamsyres påvirkning af seromdannelse efter mastektomier
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of tranexamic acid on wound fluid formation after breast
    removal
    Tranexamsyres effekt på dannelse af sårvæske efter brystfjernelse
    A.4.1Sponsor's protocol code number76873
    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 SponsorPlastikkirurgisk og brystkirurgisk afdeling, Region Sjælland
    B.1.3.4CountryDenmark
    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 supportPlastikkirurgisk og brystkirurgisk afdeling, sjællands universitetshospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPlastikkirurgisk og brystkirurgisk afdeling, Region Sjælland
    B.5.2Functional name of contact pointPlast-og brystkirurgisk afdeling
    B.5.3 Address:
    B.5.3.1Street AddressSygehusvej 10
    B.5.3.2Town/ cityRoskilde
    B.5.3.3Post code4000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4540151505
    B.5.5Fax number+4540151505
    B.5.6E-mailvosc@regionsjaelland.dk
    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 Tranexamic acid
    D.2.1.1.2Name of the Marketing Authorisation holderStragen
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.2Product code b02aa02
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTranexamic acid
    D.3.9.1CAS number 1197-18-8
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    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
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboTopical
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immunomodulation of postoperative inflammatory reactions and thereby
    reduction of wound seroma by topical
    administration of tranexamic acid.
    Immunomodulation af postoperative inflammatoriske reaktioner og
    dermed reduktion af dannelse af serom efter mastektomi via topisk
    appliceret tranexamsyre
    E.1.1.1Medical condition in easily understood language
    Reduction of inflammatory reactions and wound fluid after breast
    removal by externally applied tranexamic acid
    Reduktion af betændelsesreaktion efter brystfjernelse og dermed
    reduksjon af sårvæskeproduktion og bedre heling ved udvortes brug af
    tranexamsyre
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002784
    E.1.2Term Antifibrinolysis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tranexamic acid (TXA) is traditionally used to reduce per-and
    postoperative bleeding. The drug is applied IV or perorally, and most
    studies focus on reduction of bleeding. TXA is primarily known as an
    antifibrinolytic, less attention is paid to its immunomodulatory effects
    via plasmin inhibition. Attenuated postoperative inflammatory response
    could potentially reduce postoperative oedema, seroma formation, pain
    and wound healing complications. Topical administration of TXA provide
    low systemic absorbtion, reducing the risk of adverse effects. In this
    projcet we aim to investigate the immunomodulatory properties of TXA
    and and possible reduction of seroma formation after mastectomies and
    thereby improvement of the post operative period
    Tranexamsyre (TXA) bruges traditionelt ved kirurgi for reduktion af perog
    postoperativ blødning. Lægemidlet bruges intravenøst eller peroralt,
    og de fleste studier fokuserer på reduktion af blødning. TXA er mest
    kendt som et antifibrinolytikum, og mindre kendt som immunmodulator
    effekt via hæmning af plasmin. En svækket post-operativ inflammatorisk
    reaktion kunde reducere postoperativt ødem, dannelse af serom, smerte
    og sårhelings-komplikationer. Topisk administrering af TXA giver lav
    systemtisk absorbation, samtidig som det reducerer risikoen for
    bivirkninger. I dette projektet ønsker vi at undersøge TXAs
    immunmodulerende egenskaber og med denne reduktion at
    seromdanelse efter mastektomier og eventuelt positv effekt på den
    postoperative
    periode.
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All criteria must be filled
    - Patients scheduled for unilateral mastectomies
    - able patients
    - signed informed consent
    - Danish in writing and speech
    Alle skal opfyldes
    o Patienter hvor der er planlagt enkeltsidig mastektomi
    o Samtykkekompetente patienter
    o Skriftlig informeret samtykke
    o Dansk i skrift og tale
    E.4Principal exclusion criteria
    - unable patients
    - Procedures where there will not be preformed mastectomy without
    reconstruction.
    - Lacking signed informed consent
    - Immunological conditions, including autoimmune conditions such as
    rheumatoid arthritis, diabetes mellitus, inflammatory bowel disease,
    Lupus Erythematosus, Multiple Sclerosis, psoriasis
    o Ikke samtykkekompetente patienter
    o Indgreb hvor der ikke er planlagt mastektomi uden rekonstruktion
    o Manglende skriftligt samtykke
    o Immunologiske lidelser, herunder autoimmune sygdomme som
    rheumatoid artrit, diabetes mellitus, Inflammatory Bowel Disease, Lupus
    Erythematosus, Multippel sklerose , psoriasis.
    E.5 End points
    E.5.1Primary end point(s)
    We aim to optimize the post operative period by topical application of
    tranexamic acid to the surgical site after mastectomy
    We will measure the effect by performing growth factor profiling,
    inflammatory profiling, histopathological evaluation, microbiological
    analysis and planimetry of cikatrix. This will be done by
    analysis of blood, fluid and tissue
    Vi ønsker at optimere det postoperative forløb efter mastektomier ved
    topisk appliation af tranexamsyre på det kirurgiske felt.
    Vi ønsker at måle denne effekt ved vækstfaktorprofilering, beskrivelse af
    sårenes inflammatoriske profil, histopatologisk evaluering,
    mikrobiologiske analyser, og klinisk ved brug af planimetri. Dette vil
    gøres ved analyser af blood, væsker og væv
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre-operatively (baseline) (blood samples)
    Peroperatively (punch biopsy, planimetry)
    XML File Identifier: sx2cTpGUVsQoj2aAg8nAhevbodk=
    Page 12/21
    80 min postoperatively (blood samples, wound fluid, planimetry)
    3 - 5 th day (punch biopsy, wound fluid, planimetry)
    8-12 th day (punch biopsy, wound fluid, planimetry)
    Follow up after 3 months
    Præ-operativt (baseline) (blodprøver)
    Peroperativt (stansebiopsi, planimetri)
    80 min postoperativt (blodprøver, sårvæske, planimetri)
    3 - 5 dag (stansebiopsi, sårvæske, planimetri)
    8-12 (12-16). dag (stansebiopsi,sårvæske, planimetri)
    Kontrol 3 mnd efter indgreb, sammenfaldende med sedvanlig kirurgisk
    resultatkontrol
    E.5.2Secondary end point(s)
    We will register the following on every out-patient visit according to the
    time points
    • Status at the out-patient controls
    • Potential need for extra controls
    • Infection/complication
    • Haematoma/ bleeding
    • Need for revision
    • For how long follow up is needed
    -Pictures will be taken for the program imageJ for planimetry
    Vi måler ved hvert besøg:
    • Status ved de ambulante kontroller
    • Eventuelt behov for ikke-planlagt kontrol
    • Infektion/komplikation
    • Hæmatom/blødning
    • Behov for revision
    • Hvor lang tid er der behov for opfølgning
    • Evaluering af cikatrice ved patient og investigator
    -Det skal tages billeder med image J for planimetri
    E.5.2.1Timepoint(s) of evaluation of this end point
    English Will be measured with the primary endpoints
    Måles med de primære endpoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) 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 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.8.2.4Number of treatment arms in the trial2
    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 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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state120
    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)
    none
    ingen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-01-31
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