[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemostatic-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemostatic-disorder":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100560008","coagulation-disorders-secondary-to-two-plasmapheresis-techniques-double-filtration-plasmapheresis-vs-pfs-descriptive-pilot-study-100560008",false,"NCT06571552","Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.","Description of Coagulation Disorders Secondary to Two Plasmapheresis Techniques (Double Filtration Plasmapheresis vs. PFS). Descriptive Pilot Study.","APHERCOAG","Inclusion Criteria:\n\n* Patients without renal failure treated with chronic therapeutic plasmapheresis with a minimum treatment interval of 10 days and who can be treated with single plasma exchange (SPE) or double filtration plasmapheresis (DFPP) in accordance with the international recommendations.\n* Therapeutic plasmapheresis with regional citrate anticoagulation.\n* Patients over 18 years of age.\n* Patient affiliated to or benefiting from a social security scheme.\n* Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Patients treated with oral anticoagulants or anti-platelet agents.\n* Patients treated for hypercholesterolaemia or hypertriglyceridaemia; hyperviscosity, acquired haemophilia or nephrotic syndrome.\n* Indication for substitution with fresh frozen plasma (FFP) for the treatment of the disease.\n* Patient in an exclusion period determined by another study.\n* Patient under court protection, guardianship or curatorship.\n* Patient unable to give consent.\n* Patient for whom it is impossible to give informed information.\n* Pregnant or breast-feeding patients.","ALL","18 Years",{"count":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"NA","Therapeutic plasmapheresis causes changes in haemostasis by purifying many of the circulating factors involved. Few reliable data are available on these changes and most studies are limited to coagulation factor assays before and after the session, with little data documenting the kinetics of regeneration of these factors. It is recognized that haemostasis disorders caused by therapeutic apheresis must be corrected in cases of active bleeding. However the methods of correcting these disorders are debatable. Finally, it is unclear when changes in haemostasis associated with coagulation factor deficiency should be corrected. Haemostasis is probably not based solely on the level of blood fibrinogen, but it is most often its threshold that is used to trigger replacement therapy to prevent a supposed risk of haemorrhage. No studies are available on the kinetics of haemostasis disorders and the risk of haemorrhage following a therapeutic plasmapheresis session, according to session type and fibrinogen level at the end of the session. The hypothesis of this research is that the link between fibrinogen level and thrombin generation capacity, post therapeutic plasmapheresis, will enable us to better assess the risk of haemorrhage and propose preventive measures.",[27,28],"Hyperfibrinogenemia","Hemostatic Disorder",[30,31],"Double Filtration Plasmapheresis","Single Plasma Exchange","RECRUITING","2024-12-18",{"date":35,"type":36},"2024-12-20","ACTUAL",{"date":38,"type":36},"2024-12-17",{"date":40,"type":21},"2026-06",{"name":42,"class":43},"Centre Hospitalier Universitaire de Nīmes","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100534709","coagulopathy-in-childhood-acute-lymphoblastic-leukaemia-100534709","NCT06242353","Coagulopathy in Childhood Acute Lymphoblastic Leukaemia","Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment","CoagCALL","Inclusion Criteria:\n\n* Diagnosis of Acute Lymphoblastic Leukaemia (ALL) in Sweden\n* Age 1-17.99 years at diagnosis\n* Planned\u002FInitiated treatment for ALL according to the ALLTogether1 protocol\n* Signed informed consent from parents and patients (from 12 years - voluntary if \\\u003C15 years)\n\nExclusion Criteria:\n\n* Other underlying diseases which according to examiner's clinical assessment may increase the risk of bleeding or thrombosis and which are expected to lead to adaption of the therapy protocol for ALL (e g APS, moderate\u002Fsevere v Willebrand disease, haemophilia)\n* Patient not treated according to the ALLTogether1 protocol (including patients with BCR::ABL1, mixed phenotype acute leukaemia - MPAL)","1 Year","17 Years",{"count":56,"type":21},100,"OBSERVATIONAL","The goal of this study is to investigate the hemostatic balance in children with acute lymphoblastic leukaemia (ALL) treated according to the ALLTogether1 protocol with focus on the early treatment period including concomitant use of steroids and asparaginase.\n\nThe investigators aim to determine if complement proteins or microparticles can be used as clinically relevant predictive or diagnostic biomarkers for thrombosis and if global hemostatic assays can predict bleeding or thrombosis. Characterization of proteins connected to hemostasis before and during ALL treatment may provide pathophysiological insights regarding ALL- and treatment related coagulopathy. The ultimate goal of the study is to minimize the morbidity and mortality related to thrombosis and bleeding complications in children with ALL.\n\nSeveral pediatric oncology centers in Sweden will be participating in this study, which will enroll approximately 100 pediatric patients.",[60,61,62,28],"Acute Lymphoblastic Leukemia","Thrombosis","Bleeding","NOT_YET_RECRUITING","2024-02-02",{"date":66,"type":36},"2024-02-05",{"date":68,"type":21},"2024-03-01",{"date":70,"type":21},"2028-11",{"name":72,"class":43},"Karolinska University Hospital"]