Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients

Dose-adjustment of enoxaparin by a bayesian pharmacological approach in pediatric renal transplant recipients - OPTI-TREX

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000099-12-FR

Enrollment

Registered

2021-07-09

Start date

2021-10-12

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allograft vascular thrombosis MedDRA version: 20.0 Level: PT Classification code 10072226 Term: Renal vascular thrombosis System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Enoxaparin Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ENOXAPARIN SODIUM CAS Number: 9041-08-1 Concentration unit: IU/ml international unit(s)/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) pediatric renal transplant recipients 2) aged > 2 years and 24h, multiple renal vessels 4) informed consent form signed by the legal guardian(s) 5) affiliated to a health insurance system Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) per-transplant technical surgical problems 2) pre-inclusion allograft thrombosis (before randomization and enoxaparin administration) 3) peri-operative thrombosis or 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 prophylactic before transplant

Design outcomes

Primary

Measure	Time frame
Main Objective: To optimize the dose of enoxaparin in order to achieve appropriate anti-Xa activity in pediatric renal transplantation.;Secondary Objective: •To maintain target-range anti-Xa activity at all assessments during the first week of treatment •To assess the safety of this approach. ;Primary end point(s): Anti-Xa activity within target ranges (0.3-0.5 IU/mL) 28-30 hours after initiation of treatment.;Timepoint(s) of evaluation of this end point: 28-30 hours after initiation of treatment	—

Measure

Time frame

Main Objective: To optimize the dose of enoxaparin in order to achieve appropriate anti-Xa activity in pediatric renal transplantation.;Secondary Objective: •To maintain target-range anti-Xa activity at all assessments during the first week of treatment •To assess the safety of this approach. ;Primary end point(s): Anti-Xa activity within target ranges (0.3-0.5 IU/mL) 28-30 hours after initiation of treatment.;Timepoint(s) of evaluation of this end point: 28-30 hours after initiation of treatment

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Secondary

Measure	Time frame
Secondary end point(s): • Time to achieve a target anti-Xa activity (0.3-0.5 IU/mL) • Anti-Xa activity within target ranges from H28-30 to D7 after initiation of treatment (same method as primary endpoint) • Graft thrombosis : assessed by allograft ultrasound • Enoxaparin-related side effects during the first postoperative month: bleeding (all localisations), graft hematoma (presence/absence): assessed by ultrasound • Allograft bleeding: bleeding with post-operative transfusion • Enoxaparin induced thrombopenia ;Timepoint(s) of evaluation of this end point: - H28-30 to D7 after initiation of treatment - D30	—

Measure

Time frame

Secondary end point(s): • Time to achieve a target anti-Xa activity (0.3-0.5 IU/mL) • Anti-Xa activity within target ranges from H28-30 to D7 after initiation of treatment (same method as primary endpoint) • Graft thrombosis : assessed by allograft ultrasound • Enoxaparin-related side effects during the first postoperative month: bleeding (all localisations), graft hematoma (presence/absence): assessed by ultrasound • Allograft bleeding: bleeding with post-operative transfusion • Enoxaparin induced thrombopenia ;Timepoint(s) of evaluation of this end point: - H28-30 to D7 after initiation of treatment - D30

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Countries

France

Contacts

Public ContactDRCI, Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

alexandra.bruneau@aphp.fr33144 84 17 12

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026