2024-513650-30-00招募中3 期
OPTI-TREX - Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Anti-Xa activity within the target range (i.e., success defined by an anti-Xa activity ≥0.3 IU/mL and ≤0.5 IU/mL) 28-30 hours after initiation of treatment.
研究概览
简要总结
To optimize the dose of enoxaparin in order to achieve appropriate antiXa activity in pediatric renal transplantation.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •pediatric renal transplant recipients
- •aged ≥ 2 years and ≤20 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
- •LMWH prophylactic before transplant
- •UFH (unfractionated heparin) treatment during renal transplantation with an anti-Xa level detectable 4-6h post administration
结局指标
主要结局
Anti-Xa activity within the target range (i.e., success defined by an anti-Xa activity ≥0.3 IU/mL and ≤0.5 IU/mL) 28-30 hours after initiation of treatment.
Anti-Xa activity within the target range (i.e., success defined by an anti-Xa activity ≥0.3 IU/mL and ≤0.5 IU/mL) 28-30 hours after initiation of treatment.
次要结局
未报告次要终点
研究者
Pr Olivia BOYER
Scientific
Assistance Publique Hopitaux De Paris
研究点 (8)
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