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IRCT20231021059793N1 IRCT 2024-02-28 Tehran University of Medical Sciences Effect of Rivaroxaban in Thrombosis Rivaroxaban trial Evaluation of efficacy and adverse effects of rivaroxaban in children with central venous catheter thrombosis 2024-03-20 anticipated 20 Complete https://irct.ir/trial/73338 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Thrombosis. Intervention group: children with CVC-VTE that would receive 5 days of Enoxaparin and then 30 days of Rivaroxaban.. Yes - There is a plan to make this available What will be shared: Participant data sets are to be shared When: Starting 6 months after publication To whom: Available for people working in academic institutions Conditions: No other criteria is needed Where to obtain: Azadeh Kiumars, Children medical hospital How to obtain: akiumarsi@sina.tums.ac.ir Comments:
public Azadeh Kiumarsi
Children medical hospital, Gharib st, Keshavarz Blv., Tehran
Tehran Iran (Islamic Republic of) 1467683815 +98 21 4761 0000 akiumarsi@sina.tums.ac.ir Tehran University of Medical Sciences scientific Azadeh Kiumarsi
Children medical hospital, Gharib st, Keshavarz Blv., Tehran
Tehran Iran (Islamic Republic of) 1467683815 +98 21 8857 9492 akiumarsi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 2-18 years old CVC-VTE diagnosed by US Doppler Five days received enoxaparin or heparin 2 years 18 years Both Active bleeding History of anaphylaxis to rivaroxaban Usage of other anticoagulant drugs including ASA, platelet inhibitors, NSAID, Fibrinolytic, SSRI and SNRI Acutely ill patients with increased risk of bleeding including bronchiectasis, pulmonary cavitation, pulmonary hemorrhage, active cancer, recent HSCT in last 3 months, active GI ulcer or recent GI bleeding in the last 3 months, Liver disease with coagulopathy Patients needing spinal anesthesia or LP Creatinine clearance lower than 30 ml/min Platelet count lower than 75 X 109 Dialysis catheter or artificial heart leaflet Unstable hemodynamic I82 Other venous embolism and thrombosis Treatment - Drugs Intervention group: children with CVC-VTE that would receive 5 days of Enoxaparin and then 30 days of Rivaroxaban. Occurrence of thrombosis. Timepoint: Efficacy of Rivaroxaban is evaluated by Doppler ultrasound conducted 30 days after drug administration. Method of measurement: Follow-up ultrasound. Tehran University of Medical Sciences Approved 2023-09-17 Ethics committee of Tehran University of Medical Sciences Children medical hospital, Gharib st, Keshavarz Blv., Tehran Tehran Tehran Iran (Islamic Republic of)