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    Summary
    EudraCT Number:2018-002510-13
    Sponsor's Protocol Code Number:TROMBOFIBtrial
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-002510-13
    A.3Full title of the trial
    Impact of two thrombelastography-guided strategies of fibrinogen correction on blood product requirements in liver transplantation: a multicenter, randomized trial. TROMBOFIB trial
    Impacto de dos estrategias de corrección del fibrinógeno guiadas por tromboelastograma sobre el requerimiento de concentrados de hematíes en el trasplante hepático: estudio multicéntrico, aleatorizado. TROMBOFIB trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficay of fibrinogen in liver transplantation
    Eficacia del fibrinógeno en el transplante hepático
    A.4.1Sponsor's protocol code numberTROMBOFIBtrial
    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 SponsorAntoni Sabaté Pes (Servicio de Anestesiología y Reanimación) del Hospital Universitari de Bellvitge
    B.1.3.4CountrySpain
    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 supportFondos de Investigación Sanitarias (FIS) Instituto Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntoni Sabaté Pes (Servicio de Anestesiología y Reanimación) del Hospital Universitari de Bellvitge
    B.5.2Functional name of contact pointAntoni Sabaté Pes
    B.5.3 Address:
    B.5.3.1Street AddressCalle Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat (Barcelona)
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number34932602487
    B.5.5Fax number34932607998
    B.5.6E-mailasabatep@bellvitgehospital.cat
    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 RIASTAP
    D.2.1.1.2Name of the Marketing Authorisation holderCSL BERHING
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNHuman fibrinogen
    D.3.9.3Other descriptive nameFIBRINOGEN
    D.3.9.4EV Substance CodeSUB127282
    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 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 RIASTAP
    D.2.1.1.2Name of the Marketing Authorisation holderCSL BERHING
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNHuman fibrinogen
    D.3.9.3Other descriptive nameFIBRINOGEN
    D.3.9.4EV Substance CodeSUB127282
    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
    Liver transplantation is a special risk situation for acute and severe bleeding determined by the complexity of the surgical procedure and by the alteration of haemostasis and coagulation factors, especially fibrinogen, present in the patient affected by a terminal hepatopathy.
    El transplante hepático es una situación especial de riesgo de sangrado agudo y grave determinado por la complejidad del procedimiento quirúrgico y por la alteración de la hemostasia y de factores de la coagulación, en especial del fibrinógeno, presentes en el paciente afecto de una hepatopatía terminal.
    E.1.1.1Medical condition in easily understood language
    Liver transplantation is susceptible to acute and severe bleeding because it is a complex surgery and the patients with terminal liver disease have coagulation disorders.
    El trasplante hepático es susceptible al sangrado agudo y grave ya que se trata de una cirugía compleja y los pacientes con enfermedad hepática terminal tienen alteración de la coagulación.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10024716
    E.1.2Term Liver transplantation
    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
    To demonstrate that the correction of A10FIBTEM values ​​by administering fibrinogen up to an A10FIBTEM value of 11 mm is obtained, reduces the administration of packed red blood cells during the transplant procedure and in the first 24 subsequent, in comparison with the administration of fibrinogen up to obtain a value of A10FIBTEM of 8 mm (considered this value as the minimum value required in standard practice).
    Demostrar que la corrección de valores de A10FIBTEM mediante la administración de fibrinógeno hasta obtener un valor de A10FIBTEM de 11 mm, reduce la administración de concentrado de hematíes durante el procedimiento del trasplante y en las primeras 24 posteriores, en comparación con la administración de fibrinógeno hasta obtener un valor de A10FIBTEM de 8 mm (considerado este valor como el valor mínimo requerido en la práctica estándar).
    E.2.2Secondary objectives of the trial
    Demonstrate that the correction of A10FIBTEM values ​​by administration of fibrinogen to obtain a value of A10FIBTEM of 11 mm compared to the administration of fibrinogen to obtain an A10FIBTEM value of 8mm:

    1. Reduces the additional administration of all blood derivatives: plasma, fibrinogen, prothrombin complex, tranexamic acid
    2. Decreases acute kidney damage according to KDIGO criteria at one week and 90 days post-transplant
    3. Decreases the hours of mechanical ventilation in the postoperative period.
    4. Decreases postoperative complications according to the Clavien-Dindo classification.
    5. Does not increase thrombotic events in the hepatic graft or in the patient in the first 90 days of the transplant.
    6. It does not increase the reinterventions due to hemorrhage, retransplantation, or mortality in the first 90 days of the transplant.
    Demostrar que la corrección de valores de A10FIBTEM mediante la administración de fibrinógeno hasta obtener un valor de A10FIBTEM de 11 mm en comparación con la administración de fibrinógeno hasta obtener un valor A10FIBTEM de 8mm:

    1. Reduce la administración adicional de todos los derivados sanguíneos: plasma, fibrinógeno, complejo protrombínico, ácido tranexámico
    2. Disminuye el daño renal agudo según criterios de KDIGO a la semana y a los 90 días postrasplante
    3. Disminuye las horas de ventilación mecánica en el periodo postoperatorio.
    4. Disminuye las complicaciones postoperatorias valoradas según la clasificación de Clavien-Dindo.
    5. No incrementa los eventos trombóticos en el injerto hepático o en el paciente en los primeros 90 días del trasplante.
    6. No incrementa las reintervenciones por hemorragia, retrasplante, ni la mortalidad en los primeros 90 días del trasplante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult men and women (≥18 years old)
    - Being a candidate for an orthotopic liver transplant
    - To have granted the Informed Consent to participate in the study
    - Final inclusion criteria: Preoperative hemoglobin </ = 130 g/L as a result of the blood determination obtained when the patinet arrives to the hospital to perform the liver transplant
    - Hombres y mujeres adultos (≥18 años)
    - Ser candidato a la realización de un trasplante ortotópico de hígado,
    - Haber otorgado el Consentimiento Informado para participar en el estudio
    - Criterio de inclusión final: Hemoglobina preoperatoria </=130 g/L según resultado de la determinación sanguínea obtenida en el momento de la llegada del paciente al centro hospitalario para efectuar el trasplante hepático
    E.4Principal exclusion criteria
    Clinical exclusion criteria: preoperative hemoglobin> 130 g/L or any of the following clinical situations:

    - Familial amyloid polyneuropathy
    - Hepatic Polycystosis
    - Live donor receptor
    - Receiver of donor in asystole, Maastricht type 2
    - Acute / subacute liver failure
    - Retransplantation in acute phase (first transplant in the same hospitalization)
    - Pregnancy and lactation.
    - Age less than 18 years
    Criterios de exclusión clínicos:

    - Hemoglobina preoperatoria > 130 g/L o cualquiera de las siguientes situaciones clínicas:
    - Polineuropatia amiloide familiar
    - Poliquistosis hepática
    - Receptor de donante vivo
    - Receptor de donante en asistolia, Maastricht tipo 2
    - Insuficiencia hepática aguda/subaguda
    - Retrasplantes en fase aguda (primer trasplante en el mismo ingreso)
    - Embarazo y lactancia.
    - Edad inferior a 18 años
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients that require concentrates
    El porcentaje de pacientes que requieran concentrados
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the intraoperative and in the 24 hours post surgery
    Durante el intraoperatorio y en las 24 horas post cirugía
    E.5.2Secondary end point(s)
    1. All blood products administered during the intraoperative period and the first 24 hours postoperatively. They will be considered in absolute values ​​and percentages.
    2. Measurement of intraoperative bleeding by the sum of losses per aspirator plus gauze weight.
    3. Thrombotic events in the graft or in the patient within 90 days after liver transplantation
    4. Incidence of acute kidney injury assessed by the KDIGO criteria at 90 days after transplantation
    5. Days (number of hours) of mechanical ventilation in the postoperative period
    6. Incidence of postoperative complications evaluated by Clavien Dindo classification in the 90 days post-transplant
    7. Re-intervention for any cause in the 90 days post transplant
    8. Retransplant and Mortality in the 90 days post transplant

    Security Variables:
    - Each case of massive transfusion (> 6 red blood cell concentrates), thrombosis or other serious adverse effects will be collected and then will be assessed by an ad hoc committee that includes promoter and PI of each center.

    Additional Variables:
    - Demographic data of the patients, blood count, ionogram and renal function, hemostasis and thromboelastometry tests before and after administration of the drug, in the different phases of the procedure.
    1. Todos los hemoderivados administrados durante el intraoperatorio y las primeras 24 horas del postoperatorio. Se consideraran en forma de valores absolutos y en porcentajes.
    2. Medida del sangrado intraoperatorio mediante la suma de perdidas por aspirador más peso de gasas.
    3. Eventos trombóticos en el injerto o en el paciente en los 90 días posteriores al trasplante hepático
    4. Incidencia de lesión renal aguda evaluada mediante los criterios de KDIGO a los 90 días posteriores al trasplante
    5. Días (nº de horas) de ventilación mecánica en el postoperatorio
    6. Incidencia de complicaciones postquirúrgicas evaluadas mediante la clasificación de Clavien Dindo en los 90 días post trasplante
    7. Re intervención por cualquier causa en los 90 días post trasplante
    8. Retrasplante y Mortalidad en los 90 días post trasplante

    Variables de Seguridad:
    - Se recogerá cada caso de transfusión masiva (>6 concentrados de hematíes), trombosis u otros efectos adversos graves que serán valorados por un comité ad hoc que incluya promotor e IP de cada centro.

    Variables Adicionales:
    - Datos demográficos de los pacientes, determinaciones del hemograma, ionograma y función renal, pruebas de hemostasia y tromboelastometría pre y post administración del fármaco, en las distintas fases del procedimiento fases del procedimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the intraoperative and the first 90 days post transplant
    Durante el intraoperatorio y los primeros 90 días post trasplante
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Riastap
    Riastap
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    Last visit of the last subject (LVLS)
    La última visita del último paciente.
    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: 158
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 2018-08-07. 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 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 state176
    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)
    There is no provision for additional treatments for subjects who have completed their participation in the trial. The treatment of patients once the test is completed, will be determined according to usual clinical practice.
    No hay previsión de tratamientos adicionales para los sujetos que han finalizado su participación en el ensayo. El tratamiento de los pacientes una vez finalizado el ensayo, será el determinado según práctica clínica habitual.
    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 Decision2018-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
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