Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients - OPTI-TREX

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS0 个研究点目标入组 50 人开始时间: 2021年7月9日最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•1) pediatric renal transplant recipients
•2) aged > 2 years and <18 years
•3) 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 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
•4) informed consent form signed by the legal guardian(s)
•5) affiliated to a health insurance system
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 50
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) per-transplant technical surgical problems
•2) pre-inclusion allograft thrombosis (before randomization and enoxaparin administration)
•3) peri-operative thrombosis or bleeding (before randomization and enoxaparin administration)
•4) peri-operative hemodynamic instability
•5) medical history of heparin-induced thrombocytopenia
•6) allergic reaction to enoxaparin or excipients
•7) pregnancy
•8) LMWH prophylactic before transplant

发起方