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. The 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. Several pediatric oncology centers in Sweden will be participating in this study, which will enroll approximately 100 pediatric patients.
Study Type
OBSERVATIONAL
Enrollment
100
Standard coagulation tests: APT (Activated Partial Thromboplastin Time), PT/INR (Prothrombin Time Test), Protein-C, Protein-S, Fibrinogen, Antithrombin, D-dimers. Global haemostasis assays: CAT (Calibrated Automated Thrombogram), OHP (Overall Haemostatic Potential), Fibrin clot turbidity assay, microparticle detection by flow cytometry, scanning electron microscopy. Protein expression profile (mass spectroscopy) Ultrasound of catheterised neck veins to detect clots
Coagulation events (thrombosis and/or 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)
Time frame: From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)
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)
Time frame: From diagnosis until the start of the subsequent phase of therapy (day 0 to 106 in protocol therapy)
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
Time frame: At the end of induction (protocol day 29 +/- 3 days)
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