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OPTI-TREX - Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients
EU CTIS ID: 2024-513650-30-00
What this study is testing
To optimize the dose of enoxaparin in order to achieve appropriate antiXa activity in pediatric renal transplantation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.