Venous thromboembolic disease in children
Conditions
Interventions
Rivaroxaban group:N/A
Standard anticoagulation program group:N/A
Sponsors
College of Pharmacy, Chongqing Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: ? Age 0~18 years old; ? Clinical diagnosis of VTE (including deep vein thrombosis and/or pulmonary embolism); ? Standard anticoagulant drugs recommended by domestic and foreign guidelines or rivaroxaban for anticoagulant therapy; ? All patients completed at least 5 days of initial heparinization; ? Children in the standard anticoagulation program group continued to use UFH/LMWH or changed to VKA anticoagulation after initial heparinization, and the specific administration plan was formulated according to the drug labels or domestic and foreign antithrombotic diagnosis and treatment guidelines; ? 5 to 9 days after initial heparinization, children in the rivaroxaban group were given sequential anticoagulant therapy with rivaroxaban instead of standard anticoagulant drugs, and the specific administration regimen was developed according to EINSTEIN-Jr phase ? and phase ? clinical trials (because rivaroxaban anticoagulant therapy for VTE in children in China is off-label drug use); ? In order to avoid the additive effect of anticoagulant effect that may occur when anticoagulant drugs are adjusted, the children in the rivaroxaban group included in this study all met the conditions of starting rivaroxaban anticoagulant therapy 4 hours after stopping UFH or 6-12 hours after stopping low molecular weight heparin. If the initial anticoagulant drug is VKA, The anticoagulant drug is adjusted after the International standardized ratio (INR) is less than 2.5.
Exclusion criteria
Exclusion criteria: ? Active bleeding; ? Basic diseases of primary coagulation dysfunction (such as thrombotic thrombocytopenia (TTP)); ? Have a high risk of bleeding or contraindications to anticoagulation therapy; ? The glomerular filtration rate is less than 30mL/min/1.73m²; ? Platelet count less than 50×10?9/L; ?The clinical life expectancy of children with underlying diseases or other reasons is less than 3 months; ?Venous thromboembolism is treated with special methods (such as thrombolysis, radiofrequency ablation and surgical thrombolysis, etc.); ? Combined use of other drugs that can cause bleeding, clotting or change the level of clotting function in the child; ? The administration regimen of rivaroxaban group did not conform to the EINSTEIN-Jr clinical trial (adult equivalent dose based on body weight), and the administration regimen of standard anticoagulation regimen group did not conform to the drug labels or clinical guidelines; ? The manufacturers and specifications of anticoagulant drugs do not meet the inclusion criteria; Pediatric VTE patients with incomplete clinical data, less than 1 year after completion of anticoagulation therapy, and interruption of treatment or inability to complete follow-up due to irresistible factors such as death.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy whether the thrombus is cleared;Whether thrombus recur or not;Clinical bleeding manifestations;Changes of coagulation function index;Adverse drug reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Growth and development level; | — |
Countries
China
Contacts
Public ContactYonghong Zhang
College of Pharmacy, Chongqing Medical University
Outcome results
None listed