OPTI-TREX - Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients
- Conditions
- Allograft vascular thrombosisTherapeutic area: Not possible to specify
- Registration Number
- CTIS2024-513650-30-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method