[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534709":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":25,"armGroups":21,"interventions":26,"overallOfficials":21,"centralContacts":33,"locations":21,"responsibleParty":43,"collaborators":47,"id":50,"slug":21,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":21,"studyType":63,"phases":21,"briefSummary":64,"conditions":65,"keywords":21,"overallStatus":70,"whyStopped":21,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":21},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Coagulation events (thrombosis and\u002For bleeding) in early phases of treatment for childhood ALL according to the ALLTogether1 therapy protocol","Incidence of coagulation events during the induction and consolidation phases (first 106 days of ALL-therapy)","From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)",[14,17],{"measure":15,"description":16,"timeFrame":12},"Laboratory abnormalities indicating a risk of haemostatic events in the early phases of childhood ALL therapy","Incidence of laboratory abnormalities during the induction and consolidation phases (first 106 days of ALL-therapy)",{"measure":18,"description":19,"timeFrame":20},"Sub-clinical catheter-related thrombosis (central vein catheters) during the early phases of childhood ALL therapy","Thrombosis detected by ultrasound screening of catheterised neck veins","At the end of induction (protocol day 29 +\u002F- 3 days)",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","Patients fulfilling inclusion criteria and without exclusion criteria diagnosed at participating centres (Stockholm, Uppsala, Linköping, Lund).",[27],{"type":28,"name":29,"description":30,"armGroupLabels":21,"otherNames":31},"DIAGNOSTIC_TEST","Coagulopathy parameters","Standard coagulation tests: APT (Activated Partial Thromboplastin Time), PT\u002FINR (Prothrombin Time Test), Protein-C, Protein-S, Fibrinogen, Antithrombin, D-dimers.\n\nGlobal haemostasis assays: CAT (Calibrated Automated Thrombogram), OHP (Overall Haemostatic Potential), Fibrin clot turbidity assay, microparticle detection by flow cytometry, scanning electron microscopy.\n\nProtein expression profile (mass spectroscopy)\n\nUltrasound of catheterised neck veins to detect clots",[32],"Ultrasound",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":21,"email":38},"Mats M Heyman, M.D., PhD","CONTACT","+46706287698","mats.heyman@ki.se",{"name":40,"role":36,"phone":41,"phoneExt":21,"email":42},"Lovisa H Malmqvist, M.D.","+46739453399","lovisa.2.malmqvist@ki.se",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Mats Heyman","Associate Professor, Consultant",[48],{"name":49,"class":6},"Karolinska Institutet","100534709",false,"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)","ALL","1 Year","17 Years",{"count":61,"type":62},100,"ESTIMATED","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.",[66,67,68,69],"Acute Lymphoblastic Leukemia","Thrombosis","Bleeding","Hemostatic Disorder","NOT_YET_RECRUITING","2024-02-02",{"date":73,"type":74},"2024-02-05","ACTUAL",{"date":76,"type":62},"2024-03-01",{"date":78,"type":62},"2028-11",{"name":5,"class":6}]