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    Summary
    EudraCT Number:2021-000990-10
    Sponsor's Protocol Code Number:2021-0201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-03-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-000990-10
    A.3Full title of the trial
    FORMAT Study : Use of fibrinogen in the treatment of bleeding in thrombopenic patients after intensive chemotherapy refractory to platelet transfusion - evaluation by rotem viscoelastometry (pilot single-center study)
    Etude FORMAT : Utilisation du FibrinOgène en tRaitement des saignements chez les patients throMbopéniques après chimiothérapie intensive réfrActaires à la Transfusion plaquettaire - évaluation par viscoélastométrie rotem (étude monocentrique pilote)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    se of fibrinogen in the treatment of bleeding in thrombopenic patients after intensive chemotherapy refractory to platelet transfusion
    Utilisation du fibrinogène en traitement des saignements chez les patients thrombopéniques après chimiothérapie intensive réfractaires à la transfusion plaquettaire
    A.3.2Name or abbreviated title of the trial where available
    FORMAT
    FORMAT
    A.4.1Sponsor's protocol code number2021-0201
    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 SponsorInstitut de Cancérologie Lucien Neuwirth
    B.1.3.4CountryFrance
    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 supportInstitut de Cancérologie Lucien Neuwirth
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportARMOE (Aide à la Recherche Médicale Ondaine et Environs)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Cancérologie Lucien Neuwirth
    B.5.2Functional name of contact pointElisabeth Daguenet
    B.5.3 Address:
    B.5.3.1Street Address108 bis Avenue Albert Raimond
    B.5.3.2Town/ citySaint Priest en Jarez
    B.5.3.3Post code42270
    B.5.3.4CountryFrance
    B.5.4Telephone number+330477917089+33
    B.5.5Fax number+330477917497+33
    B.5.6E-mailelisabeth.daguenet@icloire.fr
    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 CLOTTAFACT
    D.2.1.1.2Name of the Marketing Authorisation holderlfb biomedicaments
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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
    - Major patient;
    - Patient with malignant hemopathy requiring intensive chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation;
    - Grade ≥ 1 hemorrhagic symptom according to WHO - WHO classification;
    - Body weight between 38 and 78 kg;
    - Patient presenting with a platelet refractory state defined according to the Corrected Count Increment (CCI);
    - Patient affiliated to a social security scheme
    - Patient majeur ;
    - Patient atteint d’une hémopathie maligne nécessitant la réalisation d’une chimiothérapie intensive, autogreffe ou allogreffe de cellules souches hématopoïétiques ;
    - Symptôme hémorragique de grade ≥ 1 selon la classification OMS – WHO ;
    - Poids corporel compris entre 38 et 78 kg ;
    - Patient présentant un état réfractaire aux plaquettes défini selon le Corrected Count Increment (CCI) ;
    - Patient affilié à un régime de sécurité sociale
    E.1.1.1Medical condition in easily understood language
    - Patient with malignant hemopathy requiring intensive chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation;
    - Grade ≥ 1 hemorrhagic symptom according to WHO classification;
    - Patient atteint d’une hémopathie maligne nécessitant la réalisation d’une chimiothérapie intensive, autogreffe ou allogreffe;
    - Symptôme hémorragique de grade ≥ 1 selon la classification OMS;
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066481
    E.1.2Term Hematological malignancy
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of the administration of fibrinogen associated with a platelet transfusion on the relevant visco-elastometric parameters (ROTEM method) in patients with malignant hemopathy, thrombocytopenics, refractory to platelet transfusions, with grade ≥ I hemorrhagic signs according to the WHO - WHO classification, modified according to Slichter
    Evaluer l’efficacité de l’administration de fibrinogène associée à une transfusion plaquettaire sur les paramètres visco-élastométriques pertinents (méthode ROTEM) chez des patients présentant une hémopathie maligne, thrombopéniques, réfractaires aux transfusions de plaquettes, avec des signes hémorragiques de grade ≥ I selon la classification OMS – WHO, modifiée selon Slichter
    E.2.2Secondary objectives of the trial
    - Evaluate the effect of each treatment administered on the ROTEM viscoelastometry results and the persistence of this effect at 24 hours
    - Evaluate the hemostatic response to platelet transfusion according to the Corrected Count Increment and the cause in the refractory state
    - Evaluate the visco-elastometric response according to the characteristics of the transfused platelet concentrates
    - Evaluate the hemostatic response to fibrinogen as a function of the dose received relative to the patient's weight and the plasma concentration of fibrinogen obtained
    - Evaluate the incidence of hemorrhagic and thrombotic events
    - Evaluate the impact of hemorrhagic and thrombotic risk factors
    - Evaluate the time taken to implement anti-haemorrhagic treatment
    - Compare the availability of the results of the usual coagulation tests and of the blood count with that of the results of the visco-elastometric tests
    - Evaluate the incidence of adverse events
    - Evaluer l’effet de chaque traitement administré sur les résultats en visco-élastométrie ROTEM et de la persistance de cet effet à 24h
    - Evaluer la réponse hémostatique à la transfusion de plaquettes selon le Corrected Count Increment et la cause à l’état réfractaire
    - Evaluer la réponse visco-élastométrique en fonction des caractéristiques des concentrés plaquettaires transfusés
    - Evaluer la réponse hémostatique au fibrinogène en fonction de la dose reçue rapportée au poids du malade et de la concentration plasmatique de fibrinogène obtenue
    - Evaluer l’incidence des évènements hémorragiques et thrombotiques
    - Evaluer l’impact des facteurs de risque hémorragiques et thrombotiques
    - Evaluer le temps de mise en œuvre d’un traitement antihémorragique
    - Evaluer comparativement la disponibilité des résultats des tests de coagulation usuels et de l’hémogramme avec celle des résultats des tests visco-élastométriques
    - Evaluer l’incidence des évènements indésirables
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Major patient;
    - Patient with malignant hemopathy requiring intensive chemotherapy, autologous or allogeneic hematopoietic stem cell transplantation;
    - Grade ≥ 1 hemorrhagic symptom according to WHO - WHO classification;
    - Body weight between 38 and 78 kg;
    - Patient presenting with a platelet refractory state defined according to the Corrected Count Increment (CCI);
    - Patient affiliated to a social security scheme
    - Patient majeur ;
    - Patient atteint d’une hémopathie maligne nécessitant la réalisation d’une chimiothérapie intensive, autogreffe ou allogreffe de cellules souches hématopoïétiques ;
    - Symptôme hémorragique de grade ≥ 1 selon la classification OMS – WHO ;
    - Poids corporel compris entre 38 et 78 kg ;
    - Patient présentant un état réfractaire aux plaquettes défini selon le Corrected Count Increment (CCI) ;
    - Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Patient who expressed his opposition to participating in the study;
    - Pregnant or breastfeeding woman;
    - Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9);
    - Patient with non-malignant hematological involvement;
    - Patient with a high plasma fibrinogen concentration (> 5g / L);
    - Patient allergic to fibrinogen;
    - Patient with disseminated intravascular coagulopathy;
    - Indication for the use of anti-thrombotic treatment (anti-platelet, anticoagulant).
    - Patient ayant exprimé son opposition de participer à l’étude ;
    - Femme enceinte ou allaitante ;
    - Incapacité légale ou capacité légale limitée. Conditions médicales ou psychologiques ne permettant pas au sujet de comprendre l’étude et signer le consentement (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9) ;
    - Patient présentant une atteinte hématologique non maligne ;
    - Patient présentant une concentration plasmatique de fibrinogène élevée (> 5g/L) ;
    - Patient allergique au fibrinogène ;
    - Patient présentant une coagulopathie intravasculaire disséminée ;
    - Indication à l’utilisation d’un traitement anti-thrombotique (anti-plaquettaire, anticoagulant).
    E.5 End points
    E.5.1Primary end point(s)
    Effect of the administration of fibrinogen and the transfusion of a platelet concentrate on the visco-elastometric parameter 'maximum clot elasticity' (MCE) deduced from the MCF "maximum clot firmness" of the EXTEM curve (ROTEM - initiation of coagulation with tissue factor) between the 1st and 3rd laboratory investigation (1st before administration of fibrinogen, and 3rd after administration of fibrinogen and platelets).
    Effet de l’administration de fibrinogène et de la transfusion d’un concentré plaquettaire sur le paramètre visco-élastométrique ‘maximal clot elasticity’ (MCE) déduit du MCF « maximal clot firmness » de la courbe EXTEM (ROTEM – initiation de la coagulation avec du facteur tissulaire) entre la 1ère et la 3ème investigation de laboratoire (1ère avant l’administration du fibrinogène, et 3ème après l’administration du fibrinogène et des plaquettes).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 day
    1 jour
    E.5.2Secondary end point(s)
    - Comparison of the ROTEM viscoelastometric parameters before and after treatment, under EXTEM and FIBTEM conditions (determination of the contribution of fibrinogen) and with all the other ROTEM parameters, namely: CT = clotting time; CFT = time of clot formation; angle alpha (α); MCF = maximum firmness of the clot; amplitude 5 min after CT (A5); amplitude 10 min after CT (A10); amplitude 20 min after CT (A20); amplitude 30 min after CT (A30); and maximal lysis (ML); and by the “maximal clot firmness” in FIBTEM - between the 1st, 2nd and 3rd laboratory investigation.
    - Comparison of all parameters in ROTEM viscoelastometry under EXTEM and FIBTEM conditions before and after platelet transfusion as a function of CCI and the cause in the refractory state.
    - Comparison of parameters in ROTEM viscoelastometry before and after platelet transfusion as a function of the characteristics of the platelet concentrates.
    - Comparison of the ROTEM viscoelastometry parameters before and after fibrinogen as a function of the dose received relative to the patient's weight and the plasma concentration of fibrinogen (measured by the usual laboratory test).
    - Incidence of hemorrhagic events and thrombotic events.
    - Collection of hemorrhagic and thrombotic risk factors.
    - Time from diagnosis of bleeding to administration of treatment; delay between the first ROTEM results and the administration of treatments; and ROTEM results before and after procedures.
    - Time to get the first ROTEM result and the result of conventional coagulation tests and complete blood count after blood collection.
    - Collection of adverse events and serious adverse events.
    - Comparaison des paramètres en visco-élastométrie ROTEM avant et après traitement, dans les conditions EXTEM et FIBTEM (détermination de la contribution du fibrinogène) et avec tous les autres paramètres ROTEM, à savoir : CT= clotting time ; CFT= temps de formation de caillot ; angle alpha (α); MCF= fermeté maximale du caillot ; amplitude 5 min après CT (A5); amplitude 10 min après CT (A10) ; amplitude 20 min après CT (A20) ; amplitude 30 min après CT (A30) ; et lyse maximale (ML) ; et par le « maximal clot firmness » en FIBTEM - entre la 1ère, la 2ème et 3ème investigation de laboratoire.
    - Comparaison de tous les paramètres en visco-élastométrie ROTEM dans les conditions EXTEM et FIBTEM avant et après transfusion plaquettaire en fonction du CCI et de la cause à l’état réfractaire.
    - Comparaison des paramètres en visco-élastométrie ROTEM avant et après transfusion plaquettaire en fonction des caractéristiques des concentrés plaquettaires.
    - Comparaison des paramètres en visco-élastométrie ROTEM avant et après fibrinogène en fonction de la dose reçue rapportée au poids du patient et de la concentration plasmatique de fibrinogène (mesurée par le test usuel de laboratoire).
    - Incidence des évènements hémorragiques et des évènements thrombotiques.
    - Recueil des facteurs de risque hémorragiques et thrombotiques.
    - Temps écoulé entre le diagnostic de l’hémorragie et l'administration du traitement ; délai entre les premiers résultats ROTEM et l'administration des traitements; et les résultats ROTEM avant et après les interventions.
    - Temps pour l’obtention du premier résultat ROTEM et du résultat des tests de coagulation conventionnels et de l’hémogramme après le prélèvement sanguin.
    - Recueil des événements indésirables et événements indésirables graves.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months
    2 mois
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    last visit of the last subject undergoing the trial
    Dernière visite du dernier patient inclus
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state10
    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)
    Treatment or care after the subject has ended the participation in the trial is the expected normal treatment of that condition
    Le suivi des patients après leur participation à l'étude sera celui de la prise en charge standard
    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 Decision2021-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-26
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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