Protocol for the Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Studies.

ABSTRACT:

Objectives

In post hoc analyses of our previous phase 2b Bayesian randomized clinical trial (RCT), prophylaxis with enoxaparin reduced central venous catheter (CVC)-associated deep venous thrombosis (CADVT) in critically ill older children but not in infants. The goal of the Catheter-Related Early Thromboprophylaxis with Enoxaparin (CRETE) Studies is to investigate this newly identified age-dependent heterogeneity in the efficacy of prophylaxis with enoxaparin against CADVT in critically ill children.

Design

Two parallel, multicenter Bayesian superiority explanatory RCTs, that is, phase 3 for older children and phase 2b for infants, and an exploratory mechanistic nested case-control study (Trial Registration ClinicalTrials.gov NCT04924322, June 7, 2021).

Setting

At le

SUBMITTER: Faustino EVS 

PROVIDER: S-EPMC11717624 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature