CTIS2024-513650-30-00招募中1 期
OPTI-TREX - Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients - APHP180617
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •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 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, including AME
排除标准
- •per-transplant technical surgical problems, pre-inclusion allograft thrombosis (before randomization and enoxaparin administration), peri-operative thrombosis or uncontrolled bleeding (before randomization and enoxaparin administration), peri-operative hemodynamic instability, medical history of heparin-induced thrombocytopenia, allergic reaction to enoxaparin or excipients, pregnancy, LMWH prophylactic before transplant, UFH (unfractionated heparin) treatment during renal transplantation with an anti-Xa level detectable 4-6h post administration
研究者
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