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    Summary
    EudraCT Number:2022-002259-20
    Sponsor's Protocol Code Number:CASUAL_ECMO
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2022-002259-20
    A.3Full title of the trial
    A three-arm randomized controlled non-inferiority pilot study
    Comparing Anticoagulation Strategies using Unfractionated heparin, Argatroban and Low-molecular-weight heparin for Extracorporeal Membrane Oxygenation support
    Drei-armige randomisiert kontrollierte Pilotstudie zum Vergleich von Antikoagulationsstrategien für extrakorporale Membranoxygenierung unter Verwendung von unfraktioniertem Heparin, Argatroban und Niedermolekularem Heparin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of three different blood-thinners (unfractionated heparin,
    Argatroban, low molecular-weight heparin) for the use during therapy with
    the heart-lung life-support machine
    Vergleich von drei Gerinnungshemmern/Blutverdünnern (unfraktioniertes
    Heparin, Argatroban, Niedermolekulares Heparin)zum Einsatz während der
    Therapie mit der Herz-Lungen Maschine
    A.3.2Name or abbreviated title of the trial where available
    CASUAL ECMO Trial
    A.4.1Sponsor's protocol code numberCASUAL_ECMO
    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 SponsorMedical University of Vienna
    B.1.3.4CountryAustria
    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 supportMedical University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna
    B.5.2Functional name of contact pointClinical Trials Information officer
    B.5.3 Address:
    B.5.3.1Street AddressSpitalgasse 23
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-mailjohannes.gratz@meduniwien.ac.at
    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 Inhixa
    D.2.1.1.2Name of the Marketing Authorisation holderTechdow Pharma Netherlands B.V.
    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.3.1Product nameEnoxaparin
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnoxaparin sodium
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB11933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000
    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 Yes
    D.2.1.1.1Trade name Argatra
    D.2.1.1.2Name of the Marketing Authorisation holderMitsubishi Pharma
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameArgatroban
    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 IMPIntracavernous use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNArgatroban
    D.3.9.1CAS number 74863-84-6
    D.3.9.4EV Substance CodeSUB05559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 3
    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.2.1.1.1Trade name Heparin Gilvasan
    D.2.1.1.2Name of the Marketing Authorisation holderG.L. Pharma
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameHeparin-Natrium
    D.3.4Pharmaceutical form Concentrate for concentrate for solution for 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 INNHeparin sodium
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB02478MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with indication for extracorporeal membrane oxygenation
    therapy
    Patient:innen mit Indikation für extrakorporale
    Membranoxygenierungstherapie
    E.1.1.1Medical condition in easily understood language
    Patients who need a heart-lung machine
    Patient:innen die eine Herz-Lungenmaschine benötigen
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    To evaluate the non-inferiority of Enoxaparin or Argatroban for
    anticoagulation during ECMO therapy in comparison to the current
    standard, unfractionated heparin, as measured by the incidence of
    thromboembolic events
    E.2.2Secondary objectives of the trial
    Safety Objectives
    • To assess the safety and tolerability of Enoxaparin or Argatroban in
    patients with need for ECMO support in terms of the incidence of
    bleeding events classified according to Bleeding Academic Research
    Council Criteria
    Exploratory Objectives (in comparison with unfractionated heparin)
    • To assess the impact of anticoagulation using Enoxaparin or
    Argatroban during ECMO support on the frequency of transfusions of
    blood or blood-derived products
    • To assess the effect of anticoagulation with Enoxaparin or Argatroban
    during ECMO support on daily serum hemoglobin levels and platelet
    count
    • To assess the percentage of coagulation tests within target range for
    anticoagulation with Enoxaparin or Argatroban
    • To assess the impact of anticoagulation using Enoxaparin or
    Argatroban during ECMO support on the length of ICU stay
    • To assess the impact of anticoagulation using Enoxaparin or
    Argatroban during ECMO support on mortality during the ICU stay
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients at ICUs of the MUV will be included if they are older than 18
    years and either
    • require ECMO support or
    • have been started on ECMO therapy within the last 12 hours
    E.4Principal exclusion criteria
    • Patients exhibiting contraindications to anticoagulation in general
    or any of the three investigated substances, including clinician’s
    decision to conduct ECMO support without anticoagulation due to
    extreme bleeding risk or if the clinician determines that the patient’s
    condition necessitates a specific approach to anticoagulation during
    ECMO support
    • Patients who are pregnant
    • Patients suffering from a clinically relevant pre-existing
    coagulopathy
    • Patients, for whom screening, randomization and implementation
    of study protocol cannot be initiated within 12 hours after
    cannulation
    • Patients receiving ongoing therapeutic systemic anticoagulation
    prior to ECMO implantation, or exhibiting an indication for
    therapeutic anticoagulation (e.g., pulmonary embolism)
    • Patients whose total duration of ECMO support lasts less than 24
    hours
    • Patients with start of ECMO support during CPR (eCPR)
    • Patients with passive decarboxylation, without an active pumping
    system
    • Patients, who have been weaned off ECMO support within the last
    30 days
    • Patients with central ECMO cannulation and/or after
    cardiopulmonary bypass
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of thromboembolic events during ECMO therapy i.e.:
    • Clinically relevant thromboembolic events (Clinical suspicion;
    confirmation via imaging)
    • Pulmonary embolism, deep vein thrombosis
    • Intracardiac thrombosis
    • Arterial thromboembolism including myocardial and cerebral
    infarction
    • Deep vein thrombosis (detected during daily routine sonography)
    • Need to exchange ECMO circuit due to clotting
    E.5.1.1Timepoint(s) of evaluation of this end point
    continuous evaluation, daily screening, final tabulation at end of ECMO
    therapy
    E.5.2Secondary end point(s)
    • Incidence of bleeding events classified according to BARC Criteria
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuous evaluation, daily screening, final tabulation at end of ECMO
    therapy
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 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
    End of active phase is decannulation of ECMO, followed by an observational phase until the end of ICU stay
    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 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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2023-02-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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, all further treatment is conducted according to ICU standards
    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 Decision2023-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-08-17
    P. End of Trial
    P.End of Trial StatusOngoing
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