Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients (OPTI-TREX) (OPTI-TREX)
Pediatric Kidney Transplant Recipients

About this trial
This is an interventional treatment trial for Pediatric Kidney Transplant Recipients focused on measuring Kidney transplantation, Children, Enoxaparin, Bayesian based dose, Anti-Xa activity, allograft thrombosis
Eligibility Criteria
Inclusion Criteria: Pediatric renal transplant recipients Aged ≥ 2 years and <18 years With an indication for enoxaparin treatment in the first post-transplant week according to the local transplant team such as inherited or acquired thrombotic disorders (eg. but not exclusive protein C, protein S, and antithrombin III deficiency; factor V Leiden mutation (FV506Q), prothrombin mutation (G20210A), mutation in the MTHFR (methyl Tetra hydro folate reductase) gene (C677T), and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulants), history of thrombosis, donor age < 2 years, recipient age < 5 years, cold ischemia time >24h, multiple renal vessels. Informed consent form signed by the legal guardian(s) Affiliated to a health insurance system Exclusion Criteria Per-transplant technical surgical problems Pre-inclusion allograft thrombosis (before randomization and enoxaparin administration) Peri-operative thrombosis or bleeding (before randomization and enoxaparin administration) Peri-operative hemodynamic instability Medical history of heparin-induced thrombocytopenia Allergic reaction to enoxaparin or excipients Pregnancy LMWH (Low molecular weight heparins) prophylactic before transplant
Sites / Locations
- Hôpital Necker - Enfants maladesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Bayesian based dose adjustment
Treatment as usual (empirical dose adjustment)
Optimization of the enoxaparin dose using a bayesian program in order to prevent patients from complications due to the renal transplantation. A first recommended dose of enoxaparin (50 IU/kg) is administered subcutaneously during transplantation or within the first 24 hours. Then, in the experimental group, the dose is adjusted following a bayesian program integrated in the electronic Case Report Form which is based on each patient's data as the Anti-Xa activity
Anti-Xa activity is measured and twice-daily enoxaparin empirical dose-adjustment is performed according to the usual practices in the investigating centers