[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468151":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":17,"armGroups":18,"interventions":28,"overallOfficials":13,"centralContacts":13,"locations":33,"responsibleParty":53,"collaborators":13,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":13,"enrollmentInfo":68,"targetDuration":71,"studyType":72,"phases":13,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":36,"whyStopped":13,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Hospitalisation for Vaso-occlusive crisis within one years","Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year","1 year",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","All patients in the study were diagnosed and treated for SCD at Rouen University Hospital. Patients were included during annual visit in our tertiary centre. Patients with VOC were included less than 24hours after admission to emergency department. All patients treated with hydroxyurea have been treated for at least three years. All patients received a systematic annual visit to determine VOC development in the year. Patients were analyzed in four subgroups based on genotype and clinical status:\n\n* homozygous SCD (S\u002FS) or β0 thalassemia (S\u002Fβ0) at steady state;\n* homozygous SCD with α3.7 thalassemia (S\u002FSα3.7) at steady state;\n* heterozygous SCD with C haemoglobin (S\u002FC) or β+ thalassemia (S\u002Fβ+)at steady state;\n* patients hospitalized for VOC with any genotype.",[19,24],{"label":20,"type":13,"description":21,"interventionNames":22},"Sickle cell disease","Confirmed sickle cell disease withHaemoglobin profile was determined by high performance liquid chromatography (HPLC) (Variant II Biorad, California, United States), by capillary electrophoresis on Capillarys 3 Octa® (Kit hydragel hémoglobine Sebia, Lisses, France) and iso-electrofocalisation.\n\nPatients were included during injury evaluation in our tertiary centre.",[23],"Biological: Erythrocytic parameters and thrombin generation assay measurement",{"label":25,"type":13,"description":26,"interventionNames":27},"Healthy","25 healthy controls matched on age and gender",[23],[29],{"type":30,"name":31,"description":31,"armGroupLabels":32,"otherNames":13},"BIOLOGICAL","Erythrocytic parameters and thrombin generation assay measurement",[25,20],[34],{"facility":35,"status":36,"city":37,"state":13,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Rouen university Hospital","RECRUITING","Rouen","76000","France","FR",{"type":42,"coordinates":43},"Point",[44,45],1.09932,49.44313,{"lat":45,"lon":44},[48],{"name":49,"role":50,"phone":51,"phoneExt":13,"email":52},"Paul Billoir, PhD, associate professor","CONTACT","+33232888129","paul.billoir@chu-rouen.fr",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"SPONSOR_INVESTIGATOR","BILLOIR","Associate Professor","100468151","study-of-erythrocyte-parameters-and-hypercoagulability-in-sickle-cell-disease-scd-tga-100468151",false,"NCT05376046","Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease (SCD-TGA)","Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease","SCD-TGA","Inclusion Criteria:\n\n* Sickle cell disease\n\nExclusion Criteria:\n\n* \\\u003C18 years\n* pregnancy\n* Patient under protective guardianship or curatorship",true,"ALL","18 Years",{"count":69,"type":70},200,"ESTIMATED","5 Years","OBSERVATIONAL","Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation.\n\nThe aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.",[75,76],"Sickle Cell Disease","Vaso-occlusive Crisis",[78,79,80,81,82],"sickle cell disease","vaso-occlusive crisis","reticulocyte count","thrombin generation assay","hypercoagulability","2022-05-17",{"date":85,"type":86},"2022-05-24","ACTUAL",{"date":88,"type":86},"2018-09-01",{"date":90,"type":70},"2026-09-01",{"name":55,"class":6},1]