NCT06242353

Coagulopathy in Childhood Acute Lymphoblastic Leukaemia

Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Lymphoblastic Leukemia
• Thrombosis
• Bleeding
• Hemostatic Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coagulopathy parameters	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

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2024-02-05
• Last updated: 2024-02-05