Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients (OPTI-TREX)

PHASE4RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 28, 2023

Primary Completion Date

July 31, 2026

Study Completion Date

October 31, 2026

Conditions
Pediatric Kidney Transplant Recipients
Interventions
DRUG

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."

DRUG

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.

Trial Locations (18)

33000

RECRUITING

Hôpital Pellegrin, Bordeaux

NOT_YET_RECRUITING

Hôpital Pellegrin, Bordeaux

75015

NOT_YET_RECRUITING

Hôpital Necker Enfants Malades, Paris

RECRUITING

Hôpital Necker - Enfants malades, Paris

75019

RECRUITING

Hôpital Robert Debré, Paris

NOT_YET_RECRUITING

Hôpital Robert Debré, Paris

Unknown

RECRUITING

CHU Félix Guyon, La Réunion

NOT_YET_RECRUITING

CHU Félix Guyon, La Réunion

RECRUITING

Hôpital Mère Enfant, Lyon

NOT_YET_RECRUITING

Hôpital Mère Enfant, Lyon

RECRUITING

Hôpital de la Villeneuve, Montpellier

NOT_YET_RECRUITING

Hôpital de la Villeneuve, Montpellier

RECRUITING

Hôtel Dieu, Nantes

NOT_YET_RECRUITING

Hôtel Dieu, Nantes

RECRUITING

Hôpital de Hautepierre, Strasbourg

NOT_YET_RECRUITING

Hôpital de Hautepierre, Strasbourg

NOT_YET_RECRUITING

Hôpital des Enfants, Toulouse

NOT_YET_RECRUITING

Hôpital des Enfants, Toulouse

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER