Status:
RECRUITING
Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients (OPTI-TREX)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Pediatric Kidney Transplant Recipients
Eligibility:
All Genders
2-20 years
Phase:
PHASE4
Brief Summary
Allograft vascular thrombosis is a devastating complication in kidney transplantation in adults and older children. Though uncommon, it is often irreversible and represents the main cause of graft los...
Detailed Description
The investigators will compare the efficacy of the Bayesian based dose versus the dose determined in a usual empirical way based on each physician's experience. The primary endpoint is the Anti-Xa ac...
Eligibility Criteria
Inclusion
- 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 (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.
- Informed consent form signed by the legal guardian(s)
- Affiliated to a health insurance system, including AME
Exclusion
- 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 (Low molecular weight heparins) prophylactic before transplant
- UFH (unfractionated heparin) treatment during renal transplantation with an anti-Xa level detectable 4-6h post administration
Key Trial Info
Start Date :
June 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05672550
Start Date
June 28 2023
End Date
October 1 2026
Last Update
November 20 2025
Active Locations (18)
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1
Hôpital Pellegrin
Bordeaux, France, 33000
2
Hôpital Pellegrin
Bordeaux, France, 33000
3
CHU Félix Guyon
La Réunion, France
4
CHU Félix Guyon
La Réunion, France