Studying How Age Affects Enoxaparins Ability to Prevent Catheter-Related Blood Clots in Critically Ill Children

What this Trial Is About

The CRETE Studies focus on critically ill children who are at risk of developing deep venous thrombosis DVT related to central venous catheters CVC. Researchers aim to understand how the effectiveness of enoxaparin, an anticoagulant, varies with age in preventing catheter-associated deep venous thrombosis CADVT, especially given that younger children may respond differently than older ones. The study builds on previous findings suggesting enoxaparin may reduce CADVT risk in older children but not in infants, highlighting the need for age-specific evidence. Participants are divided into groups based on age and receive different doses of enoxaparin or usual care without placebo. Older children aged 1 to 17 years receive a prophylactic dose of enoxaparin or usual care, while infants younger than 1 year receive one of two therapeutic doses of enoxaparin targeting different anti-Xa levels or usual care. The study involves two parallel randomized clinical trials to confirm the efficacy and safety of these treatments across age groups. Blood samples will be collected to explore biological mechanisms behind the age-dependent response to enoxaparin. During the study, children will be regularly monitored using ultrasound to detect CADVT and assessed clinically for any bleeding events. The primary outcome is the number of children who develop CADVT up to the removal or for a maximum of 28 days after CVC insertion. Secondary outcomes include any venous thromboembolism, clinically apparent CADVT or VTE, bleeding events, and heparin-induced thrombocytopenia within specified time frames. Safety and effectiveness data will be analyzed using Bayesian methods. The trial is sponsored by Yale University and runs until August 2027.

Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies