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Effect of Rivaroxaban in Thrombosis

Evaluation of efficacy and adverse effects of rivaroxaban in children with central venous catheter thrombosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231021059793N1
Enrollment
20
Registered
2024-02-28
Start date
2024-03-20
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis. Other venous embolism and thrombosis

Interventions

Intervention group: children with CVC-VTE that would receive 5 days of Enoxaparin and then 30 days of Rivaroxaban..

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: Age 2-18 years old CVC-VTE diagnosed by US Doppler Five days received enoxaparin or heparin

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Occurrence of thrombosis. Timepoint: Efficacy of Rivaroxaban is evaluated by Doppler ultrasound conducted 30 days after drug administration. Method of measurement: Follow-up ultrasound.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Kiumarsi

Tehran University of Medical Sciences

akiumarsi@sina.tums.ac.ir+98 21 4761 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026