Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-06 @ 2:31 PM
Study NCT ID:
NCT06619093
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D006461', 'term': 'Hemolysis'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-09-26', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall coagulation activity', 'timeFrame': 'Baseline', 'description': 'To compare the overall coagulation activity (measurement of in vitro clot formation by rotary thromboelastometry (ROTEM)) between sickle cell patients with a severe haemolytic phenotype and those with a less severe haemolytic phenotype.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemolysis', 'Coagulation', 'Red blood cell', 'Sickle cell disease'], 'conditions': ['Sickle Cell Disease (SCD)']}, 'descriptionModule': {'briefSummary': 'Sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. The investigators hypothesized that patients with sickle cell disease and severe hemolysis (Lactate Dehydrogenase level \\> 484 IU/L) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sickle cell disease, followed regularly by the Sickle Cell Center of Lyon Hospitals (Hospices Civils de Lyon).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 8 years or older\n* Under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes S/S, S/beta0, or S/C\n* Patient covered by a social security or equivalent health insurance plan\n* Collection of the non-opposition for adults\n* Information of the minor and collection of the non-opposition from both parents\n\nExclusion Criteria:\n\n* Patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion\n* Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator\\'s discretion)\n* Patient under guardianship, curatorship, or legal protection\n* Patient subject to a legal protection measure\n* Person admitted to a health or social care institution for purposes other than research'}, 'identificationModule': {'nctId': 'NCT06619093', 'acronym': 'DREPA COAG', 'briefTitle': 'Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation', 'orgStudyIdInfo': {'id': '69HCL24_0679'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High hemolytic group', 'description': 'Lactate Dehydrogenase Level \\> 484 IU/L', 'interventionNames': ['Other: blood sampling']}, {'label': 'Low hemolytic group', 'description': 'Lactacte Dehydrogenase Level less or equal to 484 IU/L', 'interventionNames': ['Other: blood sampling']}], 'interventions': [{'name': 'blood sampling', 'type': 'OTHER', 'description': '3 additional citrate tubes (2.7mL)', 'armGroupLabels': ['High hemolytic group', 'Low hemolytic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Corine Halfon-Domenech, Dr', 'role': 'CONTACT', 'email': 'Carine.HALFONDOMENECH@ihope.fr', 'phone': '+33 4 69 16 65 50'}], 'facility': 'Insitut Hématologique et Oncologique Pédiatrique (IHOPe)', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Solène Poutrel, Dr', 'role': 'CONTACT', 'email': 'solene.poutrel@chu-lyon.fr'}], 'facility': 'Service de Médecine Interne - Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Corine Halfon-Domenech, Dr', 'role': 'CONTACT', 'email': 'Carine.HALFONDOMENECH@ihope.fr', 'phone': '0033469166550', 'phoneExt': '+33'}, {'name': 'Philippe CONNES, Pr', 'role': 'CONTACT', 'email': 'philippe.connes@univ-lyon1.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laboratoire Interuniversitaire de Biologie de la Motricité (UCBL1) UR7424', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}