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    Summary
    EudraCT Number:2013-000774-30
    Sponsor's Protocol Code Number:TA-1
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-03-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000774-30
    A.3Full title of the trial
    The effect on blood loss with combined topical and intravenous tranexamic acid in cardiac surgery patients: a randomized double-blind placebo-controlled trial
    Het effect van de combinatie lokale en intraveneuze toediening van tranexaminezuur in cardiochirurgische patiënten op bloedverlies: dubbel-blind placebo-gecontroleerd onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Topical tranexamic acid in cardiac surgery patients
    Lokale toediening van tranexaminezuur in cardiochirugische patiënten
    A.3.2Name or abbreviated title of the trial where available
    Topical tranexamic acid in cardiac surgery patients
    kale toediening van tranexaminezuur in cardiochirugische patiënten
    A.4.1Sponsor's protocol code numberTA-1
    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 SponsorAmphia Hospital
    B.1.3.4CountryNetherlands
    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 supportAmphia Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmphia Hospital
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressMolengracht 21
    B.5.3.2Town/ cityBreda
    B.5.3.3Post code4818 CK
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031765951508
    B.5.5Fax number003176595
    B.5.6E-mailbgerritse@amphia.nl
    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 Cyklokapron
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer bv
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtranexamic acid
    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 placeboConcentrate and diluent for solution for infusion
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    post-operative blood loss
    post-operatief bloedverlies
    E.1.1.1Medical condition in easily understood language
    post-operative blood loss
    post-operatief bloedverlies
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 objective of this study is to determine whether the application of topical TA into the pericardial cavity just before sternal closure has an added value in the reduction of post-operative blood loss after cardiac surgery patients on CPB.
    Het doel van deze studie is het vaststellen of de toepassing van lokale toediening van tranexaminezuur een toegevoegde waarde heeft in de vermindering van post-operatief bloedverlies na open-hartchirurgie patiënten.
    E.2.2Secondary objectives of the trial
    in addition, this study is designed to compare the amount of blood component transfusion (packed red blood cells, platelet concentrate, Octoplas®, haemocomplettan®, cofact®), routine coagulation tests variables (INR, aPTT, number of platelets, fibrinogen level, Hb/Ht), rotem® variables (CT InTEM, A10 intem, angle ExTEM, A10 FibTEM) and surgical re-explorations between the three groups.
    bovendien is deze studie opgezet om te kijken naar de hoeveelheid bloed componenten transfusie (rode bloedcellen, trombocyten concentraat, Octoplas ®, haemocomplettan ®, Cofact ®), routine coagulatie testen variabelen (INR, aPTT, aantal bloedplaatjes, fibrinogeen level, Hb / Ht), rotem ®-variabelen (CT InTEM, A10 intem, angle Extem, A10 FibTEM) en chirurgische re-exploraties .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Gender; male/ female
    • Age: ≥ 18 year
    • Elective cardiac surgical patients
    o CABG (conventional, E.CCO)
    o AVR (conventional)
    o MVP/MVR (conventional)
    o TVP/ TPL
    o Bentall
    o Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/MAZE)
    • Acute patients
    • Geslacht; man/ vrouw
    • Leeftijd: ≥ 18 jaar
    • Electieve patiënten die hartchirurgie ondergaan
    o CABG (conventioneel, E.CCO)
    o AVR (conventioneel)
    o MVP/MVR (conventional)
    o TVP/ TPL
    o Bentall
    o Gecombineerde procedure (CABG/ AVR, MVR/AVR, AVR/MAZE)
    • Acute patiënten
    E.4Principal exclusion criteria
    • MVP/MVR (minimal invasive)
    • Maze (minimal invasive)
    • AVR (minimal invasive)
    • off-pump procedures
    • MVP/MVR (minimaal invasief)
    • Maze (minimaal invasief)
    • AVR (minimaal invasief)
    • off-pump procedures
    E.5 End points
    E.5.1Primary end point(s)
    The primary study parameter is post-operative blood loss and is assessed by post-operative chest tube production.
    Primaire outcome: post-operatief bloedverlies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    post-operative chest tube production 12 hours after surgical procedure
    post-operatief 12 uur
    E.5.2Secondary end point(s)
    The secondary study parameters which are assessed:
    • total amount of blood component transfusion (until discharge ICU)
    o packed red blood cells
    o fibrinogen concentrates (haemocomplettan® CSL Behring)
    o FFP (Octoplas®)
    o Platelet concentrate
    o Factor II, VII, IX en X concentrates (Cofact®)
    • Routine coagulation tests (one day before surgery, post-operative at arrival at ICU and one day after surgery)
    o INR
    o aPTT
    o number of platelets
    o fibrinogen level
    o Hct/ Hb
    • Rotem variables
    o Ct InTEM
    o A10 InTEM
    o Angle extem
    o A10 FibTEM.

    • blood component transfusie
    o packed red blood cells
    o fibrinogen concentraat (haemocomplettan® CSL Behring)
    o FFP (Octoplas®)
    o Trombocyten concentaat
    o Factor II, VII, IX en X concentraat (Cofact®)
    • Routine coagulatie test variabelen
    o INR
    o aPTT
    o trombocyten aantal
    o fibrinogen level
    o Hct/ Hb
    • Rotem variabelen
    o Ct InTEM
    o A10 InTEM
    o Angle extem
    o A10 FibTEM.
    E.5.2.1Timepoint(s) of evaluation of this end point
    preoperative one day
    post-operative at arrival at ICU, one day, discharge ICU
    pre-operatief 1 dag
    post-operatief bij aankomst IC, 1 dag, ontslag IC
    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 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 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 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
    All AEs will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow up may require additional tests or medical procedures as indicated, and/or referral to the general physician or a medical specialist.
    SAEs need to be reported till end of study within the Netherlands, as defined in the protocol
    Alle bijwerkingen worden gevolgd tot zij zijn afgenomen, of totdat een stabiele situatie is bereikt. Afhankelijk van het evenement, de follow-up kunnen aanvullende tests of medische procedures, zoals aangegeven, en / of verwijzing naar de huisarts of medisch specialist.
    SAE's moeten worden gemeld tot einde van de studie binnen Nederland, zoals gedefinieerd in het protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state600
    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
    geen
    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 Decision2013-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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