Oral Rivaroxaban in Children With Venous Thrombosis

Exclusion Criteria

• •Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
• •Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
• •Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
• •An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
• •Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk or ALT \> 5x upper level of normal (ULN) or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total
• •Platelet count \< 50 x 10\^9/L
• •Hypertension defined as \> 95th age percentile
• •Life expectancy \< 3 months
• •Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
• •Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine