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    Summary
    EudraCT Number:2022-001105-40
    Sponsor's Protocol Code Number:EDIPO_RE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-10-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-001105-40
    A.3Full title of the trial
    Effectiveness Of Different Fibrinogen Preparations In Restoring Clot Firmness
    Efficacia di differenti preparazioni di fibrinogeno nel ripristino della stabilità del coagulo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of different fibrinogen based medicines in improving coagulation
    Efficacia di differenti farmaci di fibrinogeno nel migliorare la coagulazione
    A.3.2Name or abbreviated title of the trial where available
    EDIPO_RE
    EDIPO_RE
    A.4.1Sponsor's protocol code numberEDIPO_RE
    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 SponsorI.R.C.C.S. POLICLINICO SAN DONATO
    B.1.3.4CountryItaly
    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 supportBIOVIIIx srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationI.R.C.C.S. POLICLINICO SAN DONATO
    B.5.2Functional name of contact pointLaboratorio Emostasi e Coagulazione
    B.5.3 Address:
    B.5.3.1Street AddressVia Morandi 30
    B.5.3.2Town/ citySan Donato Milanese
    B.5.3.3Post code20097
    B.5.3.4CountryItaly
    B.5.4Telephone number0252774754
    B.5.6E-mailekaterina.baryshnikova@grupposandonato.it
    D. IMP Identification
    D.IMP: 1
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameRIASTAP
    D.3.2Product code [RIASTAP]
    D.3.4Pharmaceutical form Powder and solvent 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 INNFIBRINOGENO UMANO LIOFILIZZATO
    D.3.9.1CAS number 9001-32-5
    D.3.9.2Current sponsor codeRIASTAP
    D.3.9.3Other descriptive nameHuman Fibrinogen lyophilisate
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFIBRICLOTTE
    D.3.2Product code [FIBRICLOTTE]
    D.3.4Pharmaceutical form Powder and solvent 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 INNFIBRINOGENO UMANO LIOFILIZZATO
    D.3.9.1CAS number 9001-32-5
    D.3.9.2Current sponsor codeFIBRICLOTTE
    D.3.9.3Other descriptive nameHuman Fibrinogen lyophilisate
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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
    Postoperative bleeding after cardiac surgery
    Sanguinamento post operatorio dopo cardiochirurgia
    E.1.1.1Medical condition in easily understood language
    Excessive blood loss after cardiac surgery
    Eccessiva perdita di sangue dopo intervento cardiochirurgico
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    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 differences between two drugs (RIASTAP and FIBRICLOTTE) in a series of adult patients undergoing complex cardiac surgery with extracorporeal circulation in terms of clots stability
    Valutare in una serie di pazienti adulti sottoposti ad intervento cardiochirurgico complesso con circolazione extracorporea le differenze tra due prodotti (RIASTAP e FIBRICLOTTE) in termini di qualità del coagulo
    E.2.2Secondary objectives of the trial
    To evaluate the differences between two drugs (RIASTAP and FIBRICLOTTE) in a series of adult patients undergoing complex cardiac surgery with extracorporeal circulation in terms of post operative bleeding and incidence of transfusion
    Valutare in una serie di pazienti adulti sottoposti ad intervento cardiochirurgico complesso con circolazione extracorporea le differenze tra due prodotti (RIASTAP e FIBRICLOTTE) in termini di sanguinamento post operatorio e incidenza di trasfusione
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age > 18 years;
    Absence of known or presumed coagulation diseases from the anamnestic analysis;
    Cardiac surgery with extracorporeal circulation in election;
    Complex cardiac surgery (coronary artery bypass + valve; double / triple valve, ascending aorta);
    Signature of informed consent.
    Età > 18 anni;
    Assenza di malattie della coagulazione note o presumibili dall’analisi anamnestica;
    Intervento cardiochirurgico con circolazione extracorporea in elezione;
    Intervento cardiochirurgico complesso (bypass aorto-coronarico + valvola; doppia/tripla valvola, aorta ascendente);
    Firma del consenso informato.
    E.4Principal exclusion criteria
    Urgent or emergency cardiac surgery;
    Known sensitivity to the components of the drugs under study;
    Participation in other ongoing clinical trials.
    Intervento cardiochirurgico in urgenza o emergenza;
    Nota sensibilità ai componenti dei farmaci in studio;
    Partecipazione ad altri studi clinici in corso.
    E.5 End points
    E.5.1Primary end point(s)
    Concentration of fibrinogen in the blood as a parameter of the amplitude of the MCF clot in the FIBTEM and EXTEM test by ROTEM®, and parameters of the speed and effectiveness of clot formation CT and CFT in the FIBTEM and EXTEM tests
    Concentrazione di fibrinogeno nel sangue come parametro di ampiezza del coagulo MCF al test FIBTEM ed EXTEM di ROTEM®, e parametri di velocità e efficacia della formazione del coagulo CT e CFT nei test FIBTEM ed EXTEM
    E.5.1.1Timepoint(s) of evaluation of this end point
    Postoperative bleeding in the first 12 and 24 postoperative hours, incidence of severe bleeding (moderate and higher degree of severity, as defined by UDPB), incidence of transfusion of blood products (RBCs and platelets) in the 12 and 24 postoperative hours
    Sanguinamento postoperatorio nelle prime 12 e 24 ore postoperatorie, incidenza di sanguinamento grave (grado di severità moderato e superiore, secondo la definizione UDPB), incidenza di trasfusione di emoderivati (emazie concentrate e piastrine) nelle 12 e 24 ore postoperatorie
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Patients continue to be supported due to their disease in our Institution where, on request, could receive all the required assistance
    I pazienti continuano ad essere seguiti per la loro patologia presso il nostro Istituto, dove, su richiesta, possono ricevere tutta l’assistenza necessaria
    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 Decision2022-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-07
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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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