Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-29 @ 5:10 PM
Study NCT ID:
NCT07278661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C488777', 'term': 'romiplostim'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'Day 7', 'description': 'Lowest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery'}], 'secondaryOutcomes': [{'measure': 'Transfusion of platelet concentrate', 'timeFrame': 'Day 1', 'description': 'Number of transfusion of platelet concentrate'}, {'measure': 'Transfusion of platelet concentrate', 'timeFrame': 'Day 7', 'description': 'Number of transfusion of platelet concentrate'}, {'measure': 'Transfusion of platelet concentrate', 'timeFrame': 'Day 28', 'description': 'Number of transfusion of platelet concentrate'}, {'measure': 'Transfusion of red blood cell concentrate', 'timeFrame': 'Day 1', 'description': 'Number of transfusion of red blood cell concentrate'}, {'measure': 'Transfusion of red blood cell concentrate', 'timeFrame': 'Day 7', 'description': 'Number of transfusion of red blood cell concentrate'}, {'measure': 'Transfusion of red blood cell concentrate', 'timeFrame': 'Day 28', 'description': 'Number of transfusion of red blood cell concentrate'}, {'measure': 'Transfusion of fresh frozen plasma', 'timeFrame': 'Day 1', 'description': 'Number of transfusion of fresh frozen plasma'}, {'measure': 'Transfusion of fresh frozen plasma', 'timeFrame': 'Day 7', 'description': 'Number of transfusion of fresh frozen plasma'}, {'measure': 'Administration of blood-derived drugs', 'timeFrame': 'Day 1', 'description': 'Number of administration of blood-derived drugs'}, {'measure': 'Administration of blood-derived drugs', 'timeFrame': 'Day 7', 'description': 'Number of administration of blood-derived drugs'}, {'measure': 'Administration of blood-derived drugs', 'timeFrame': 'Day 28', 'description': 'Number of administration of blood-derived drugs'}, {'measure': 'Efficacy', 'timeFrame': 'Day 28', 'description': 'Lowest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery'}, {'measure': 'Efficacy', 'timeFrame': 'Day 7', 'description': 'Highest platelet count measured between the end of ECC and the 7th postoperative day with D0 = day of surgery'}, {'measure': 'Efficacy', 'timeFrame': 'Day 28', 'description': 'Highest platelet count measured between the end of ECC and the 28th postoperative day with D0 = day of surgery'}, {'measure': 'Lowest haemoglobin', 'timeFrame': 'Day 7', 'description': 'Lowest haemoglobincount measured between the end of ECC and the 7th postoperative day with D0 = day of surgery'}, {'measure': 'Lowest haemoglobin', 'timeFrame': 'Day 28', 'description': 'Lowest haemoglobincount measured between the end of ECC and the 28th postoperative day with D0 = day of surgery'}, {'measure': 'Bleeding volume', 'timeFrame': 'Hour 12', 'description': 'Post-operative bleeding volume from sternal closure to 12th post-operative hour'}, {'measure': 'Bleeding volume', 'timeFrame': 'Day 1', 'description': 'Post-operative bleeding volume from sternal closure to 24th post-operative hour'}, {'measure': 'Mortality', 'timeFrame': 'Day 28', 'description': 'Rate of mortality'}, {'measure': 'Infection', 'timeFrame': 'Month 3', 'description': 'Rate of infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thrombocytopenia', 'Cardiac Surgery', 'Growth Factor', 'Patient Blood Management'], 'conditions': ['Chirurgical Intervention', 'Thrombocytopaenia']}, 'descriptionModule': {'briefSummary': 'Romiplostim has demonstrated its efficacy and good tolerance in multiple indications. If the efficacy of Romiplostim is confirmed in this population, thrombocytopenic patients will be able to undergo cardiac surgery, which is generally life-saving, without prior thrombocytopenia.\n\nPatients included in the study will be hospitalized within 15 days of the first administration of the study treatment and will be closely monitored clinically and biologically for at least 10 days after surgery. The occurrence of an adverse event can therefore be quickly detected and managed.\n\nCollectively, "Patient Blood Management" strategies are mainly focused on the management of preoperative anemia. If positive, this study will enrich the therapeutic arsenal available for optimizing patients in preparation for major surgery. As no major collective complications are expected, the collective benefit/risk ratio also appears favorable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with no upper age limit,\n* Scheduled cardiac surgery with cardiopulmonary bypass,\n* Patients with preoperative thrombocytopenia strictly \\<150,000/mm3\n* Surgery performed with a blood recovery system using centrifugation (Cell Saver type) or equivalent,\n* Feasibility of a first injection (Romiplostim or Placebo) between D-14 and D-10 before surgery,\n* Surgery requiring the administration of antiplatelet and/or anticoagulant therapy for a minimum of 1 month postoperatively.\n\nExclusion Criteria:\n\n* Inability to administer the first injection of Romiplostim or Placebo within 10 days prior to surgery,\n* Cardiac surgery without cardiopulmonary bypass,\n* Coronary artery bypass grafting due to one or more significant coronary stenoses,\n* Tangential filtration blood recovery system (i-SEP SAME® type) planned for intraoperative use or absence of intraoperative blood recovery system due to investigator choice or availability issues,\n* Planned use of aprotinin as an antifibrinolytic agent during surgery,\n* Patient with contraindication to discontinuation of all antiplatelet therapy before surgery (with discontinuation at least 3 days before surgery for acetylsalicylic acid and at least 5 days before surgery for clopidogrel/ticagrelor),\n* Hereditary or acquired thrombophilia with or without a history of thrombosis,\n* History of ischemic or hemorrhagic stroke,\n* History of phlebitis, pulmonary embolism, or portal vein thrombosis,\n* History of heart attack with stent placement less than one year ago,\n* Current limb immobilization (e.g., plaster cast for ankle fracture) or inability to walk independently due to limited mobility (e.g., paralysis),\n* Current immobilization of a limb (e.g., plaster cast for ankle fracture) or inability to walk independently due to motor limitation (e.g., complete paralysis of a limb) or medical contraindication (e.g., strict bed rest required),\n* Myelogram indicating malignant hematological disease or blast cells strictly greater than 5%,\n* Malignant diseases with last follow-up indicating disease progression,\n* Severe chronic liver disease with a CHILD-PUGH score \\> 6 (measured without decompensation),\n* Treatment with thrombopoietin receptor agonist received within 3 months prior to inclusion,\n* Treatment with JAK2 inhibitor currently underway or within the last month,\n* Treatment with Rituximab within the last 7.5 months or intravenous immunoglobulin within the last 40 days,\n* Ongoing treatment with corticosteroids at doses equal to or greater than 20mg of hydrocortisone, 5mg of prednisone/or prednisolone, 4mg of methylprednisone, or 0.75mg of dexamethasone,\n* Known hemophilia,\n* Hypersensitivity to romiplostim or any of its excipients, or to proteins derived from E. coli,\n* Context of hyperchloremia, hypernatremia, or major water and salt retention with anasarca refractory to medical treatment,\n* Pregnant women or women of childbearing age who are not using effective contraception,\n* Currently using combined oral contraceptive pills or oral hormone replacement therapy containing estrogen,\n* Breastfeeding women,\n* Minors,\n* Adults under guardianship, curatorship, or judicial protection,\n* Patients who do not speak French,\n* Patients without Social Security coverage.'}, 'identificationModule': {'nctId': 'NCT07278661', 'acronym': 'CT-PLATE', 'briefTitle': 'Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.', 'orgStudyIdInfo': {'id': 'RC24_0458'}, 'secondaryIdInfos': [{'id': '2024-517710-15-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Romiplostim', 'description': 'injection sc', 'interventionNames': ['Drug: Nplate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl', 'description': 'injection sc', 'interventionNames': ['Drug: NaCl %0.9']}], 'interventions': [{'name': 'Nplate', 'type': 'DRUG', 'description': 'The dosage for this first injection will be:\n\n* 2 µg/kg for patients with a platelet count at inclusion between 149,000 and 100,000/mm3\n* 3 µg/kg for patients with a platelet count strictly below 100,000/mm3', 'armGroupLabels': ['Romiplostim']}, {'name': 'NaCl %0.9', 'type': 'DRUG', 'description': 'NaCl (Sodium chloride) 0.9% administered subcutaneously', 'armGroupLabels': ['NaCl']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Emmanuel RINEAU', 'role': 'CONTACT', 'email': 'emmauel.rineau@chu-angers.fr'}], 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Alexandre OUATTARA', 'role': 'CONTACT', 'email': 'alexandre.ouattara@chu-bordeaux.fr'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Yoann MORVAN', 'role': 'CONTACT', 'email': 'yoann.morvan@chu-brest.fr'}], 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Pierre-Grégoire GUINOT', 'role': 'CONTACT', 'email': 'pierregregoire.guinot@chu-dijon.fr'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'Jean-Christophe RIGAL', 'role': 'CONTACT', 'email': 'jeanchristophe.rigal@chu-nantes.fr'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Sophie PROVENCHERE', 'role': 'CONTACT', 'email': 'sophie.provenchere@aphp.fr'}], 'facility': 'Hôpital Bichat (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Nicolas NESSELER', 'role': 'CONTACT', 'email': 'nicolas.nesseler@chu-rennes.fr'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Strasbourg', 'country': 'France', 'contacts': [{'name': 'Charles-Ambroise TACQUARD', 'role': 'CONTACT', 'email': 'charles-ambroise.tacquard@chru-strasbourg.fr'}], 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Jean- Christophe RIGAL', 'role': 'CONTACT', 'email': 'jeanchristophe.rigal@chu-nantes.fr', 'phone': '+33 240165304'}, {'name': 'Astrid GARREAU', 'role': 'CONTACT', 'email': 'astrid.garreau@chu-nantes.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}