O'Brien 2019.

Study name	PREVAPIX‐ALL: apixaban compared to standard of care for prevention of venous thrombosis in paediatric acute lymphoblastic leukaemia (ALL) – rationale and design
Methods	Multinational, multicentre, randomised, open‐label trial
Participants	Children and adolescents with acute lymphoblastic leukaemia and T/B cell lymphoblastic lymphoma receiving standard induction chemotherapy with asparaginase and the presence of a central venous access device
Interventions	Intervention: apixaban. Children 5 years or older randomised to the apixaban arm and weighing ≥ 35 kg may be administered either 2.5 mg tablets, 0.5 mg tablets, or oral solution apixaban twice daily for approximately 28 days, while children < 5 years and < 35 kg may be administered 0.5 mg tablets only. Children weighing ≥ 35 kg will be administered the adult dose of apixaban 2.5 mg twice daily Control: standard of care
Outcomes	Primary efficacy endpoint: composite of symptomatic and asymptomatic VTE that includes DVT, PE, cerebral sinovenous thrombosis, or VTE‐related death Primary safety outcome: major bleeding Secondary outcomes: central line‐associated infections, patency and line replacement, superficial thrombosis, arterial events, and death
Starting date	Not reported
Contact information	Sarah H O'Brien, sarah.obrien@nationwidechildrens.org
Notes

DVT: deep vein thrombosis; HIT: heparin‐induced thrombocytopenia; IV: intravenous; LMWH: low‐molecular‐weight heparin; PE: pulmonary embolism; RCT: randomised controlled trial;
SC: subcutaneous; TACE: transarterial chemoembolisation; VTE: venous thromboembolism.