Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients (OPTI-TREX)
NCT ID: NCT05672550
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2023-06-28
2026-10-31
Brief Summary
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However, no consensus exists regarding the optimal prophylaxis in the peri-transplant period and the following dose-adjustment, and practices are highly heterogeneous among centers. Moreover, the therapeutic target is very narrow and antithrombotic agents may conversely increase the risk of allograft hematoma. Enoxaparin is a low molecular weight heparin commonly used in this context, but off-label in children. Therapeutic ranges are based on anti-Xa levels 4 to 6 hours following injection and extrapolated from adults although evidences suggest that such extrapolation may be inappropriate in many circumstances. The current pediatric practice of dose adjustment to achieve and maintain a target anti-Xa range is empirical and dependent on the physician.
The aim of the proposed clinical trial is to assess the efficacy/safety profile of this bayesian-based dose optimization in the clinical setting, as compared to the current practices of empirical adjustment. This should greatly improve the personalized management of renal transplanted children, a subset of patients with singular renal function and little-investigated pharmacokinetics and help standardizing and rationalizing practices.
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Detailed Description
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The primary endpoint is the Anti-Xa activity within the target range 28 to 30 hours after initiation of the treatment.
This is an open labelled randomized clinical trial. The randomization will proceed during the inclusion visit by the local pediatric nephrologist or intensivist just before the first enoxaparin injection, administered within 24 hours post-transplantation.
The investigators will conduct a national multicentric study with 9 inclusion centers which are all nephrology units specialized in renal transplantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bayesian based dose adjustment
Optimization of the enoxaparin dose using a bayesian program in order to prevent patients from complications due to the renal transplantation.
A first recommended dose of enoxaparin (50 IU/kg) is administered subcutaneously during transplantation or within the first 24 hours.
Then, in the experimental group, the dose is adjusted following a bayesian program integrated in the electronic Case Report Form which is based on each patient's data as the Anti-Xa activity
Bayesian based dose adjustment of enoxaparin
A first recommended dose of enoxaparin 50 IU/kg subcutaneously is administered during transplantation or within the first 24 hours.
Then a Bayesian estimate of individual pharmacokinetics is performed to adapt the next twice daily (Hour 12;Hour 24) enoxaparin dose until achievement of the target on two consecutive measurements. Then anti-Xa activity will be evaluated once a day until day 7.
Treatment as usual (empirical dose adjustment)
Anti-Xa activity is measured and twice-daily enoxaparin empirical dose-adjustment is performed according to the usual practices in the investigating centers
Usual dose adjustment of enoxaparin
A first recommended dose of enoxaparin 50 IU/kg is administered during transplantation or within the first 24 hours. Then anti-Xa activity is measured and twice-daily (hour 12 ; hour 24) enoxaparin empirical dose-adjustment is performed according to the usual practices in the investigating centers to target.
Interventions
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Bayesian based dose adjustment of enoxaparin
A first recommended dose of enoxaparin 50 IU/kg subcutaneously is administered during transplantation or within the first 24 hours.
Then a Bayesian estimate of individual pharmacokinetics is performed to adapt the next twice daily (Hour 12;Hour 24) enoxaparin dose until achievement of the target on two consecutive measurements. Then anti-Xa activity will be evaluated once a day until day 7.
Usual dose adjustment of enoxaparin
A first recommended dose of enoxaparin 50 IU/kg is administered during transplantation or within the first 24 hours. Then anti-Xa activity is measured and twice-daily (hour 12 ; hour 24) enoxaparin empirical dose-adjustment is performed according to the usual practices in the investigating centers to target.
Eligibility Criteria
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Inclusion Criteria
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 (methyl Tetra hydro folate reductase) 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, including AME
Exclusion Criteria
2. Pre-inclusion allograft thrombosis (before randomization and enoxaparin administration)
3. Peri-operative thrombosis or uncontrolled 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 (Low molecular weight heparins) prophylactic before transplant
9. UFH (unfractionated heparin) treatment during renal transplantation with an anti-Xa level detectable 4-6h post administration
2 Years
20 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Olivia BOYER, Pr
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Pellegrin
Bordeaux, , France
Hôpital Pellegrin
Bordeaux, , France
CHU Félix Guyon
La Réunion, , France
CHU Félix Guyon
La Réunion, , France
Hôpital Mère Enfant
Lyon, , France
Hôpital Mère Enfant
Lyon, , France
Hôpital de la Villeneuve
Montpellier, , France
Hôpital de la Villeneuve
Montpellier, , France
Hôtel Dieu
Nantes, , France
Hôtel Dieu
Nantes, , France
Hôpital Necker Enfants Malades
Paris, , France
Hôpital Robert Debré
Paris, , France
Hôpital Robert Debré
Paris, , France
Hôpital de Hautepierre
Strasbourg, , France
Hôpital de Hautepierre
Strasbourg, , France
Hôpital des Enfants
Toulouse, , France
Hôpital des Enfants
Toulouse, , France
Hôpital Necker - Enfants malades
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP180617
Identifier Type: -
Identifier Source: org_study_id
2021-000099-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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