Related Experiment Video
Updated: Nov 24, 2025
Rapid Point-of-Care Assay of Enoxaparin Anticoagulant Efficacy in Whole Blood
Published on: October 12, 2012
Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b
E Vincent S Faustino1, Veronika Shabanova1, Leslie J Raffini2
1Department of Pediatrics, Yale School of Medicine, New Haven, CT.
Insights
Early enoxaparin prophylaxis in critically ill children significantly reduced central venous catheter-associated deep venous thrombosis risk. This early intervention shows promise for preventing thrombosis in pediatric intensive care units.
Area of Science:
- Pediatric critical care medicine
- Thrombosis and hemostasis
- Pharmacology and therapeutics
Background:
- Central venous catheter (CVC)-associated deep venous thrombosis (DVT) is a significant complication in critically ill children.
- Current prophylactic strategies for CVC-associated DVT in this population are limited.
- Understanding the impact of early prophylaxis on thrombin generation is crucial.
Purpose of the Study:
- To evaluate the efficacy of early enoxaparin prophylaxis in reducing CVC-associated DVT in critically ill children.
- To assess the effect of early prophylaxis on thrombin generation.
- To provide preliminary evidence for a larger randomized clinical trial.
Main Methods:
- Bayesian phase 2b randomized clinical trial conducted in seven Pediatric Intensive Care Units (PICUs).
- Inclusion of children under 18 with new CVCs and low bleeding risk.
- Intervention: Enoxaparin (anti-Xa 0.2-0.5 IU/mL) within 24 hours of CVC insertion versus usual care.
Main Results:
- The study was terminated early due to a higher-than-expected DVT rate in the usual care arm.
- Enoxaparin arm showed a reduced risk ratio of CVC-associated DVT (0.55; 95% CI, 0.24-1.11) based on ultrasonography.
- Clinically relevant DVT occurred in 3.7% of the enoxaparin group versus 29.2% in the usual care group (p=0.02).
- One case of clinically relevant bleeding occurred in the enoxaparin arm; thrombin generation was not significantly different between arms.
Conclusions:
- Early enoxaparin prophylaxis appears effective and safe in reducing CVC-associated DVT in critically ill children.
- Findings support the need for validation in a pivotal randomized clinical trial.
- This strategy may improve outcomes for pediatric patients with central venous catheters.
Objectives:
We obtained preliminary evidence on the efficacy of early prophylaxis on the risk of central venous catheter-associated deep venous thrombosis and its effect on thrombin generation in critically ill children.
Design:
Bayesian phase 2b randomized clinical trial.
Setting:
Seven PICUs.
Patients:
Children less than 18 years old with a newly inserted central venous catheter and at low risk of bleeding.
Intervention:
Enoxaparin adjusted to anti-Xa level of 0.2-0.5 international units/mL started at less than 24 hours after insertion of central venous catheter (enoxaparin arm) versus usual care without placebo (usual care arm).
Measurements And Main Results:
At the interim analysis, the proportion of central venous catheter-associated deep venous thrombosis on ultrasonography in the usual care arm, which was 54.2% of 24 children, was significantly higher than that previously reported. This resulted in misspecification of the preapproved Bayesian analysis, reversal of direction of treatment effect, and early termination of the randomized clinical trial. Nevertheless, with 30.4% of 23 children with central venous catheter-associated deep venous thrombosis on ultrasonography in the enoxaparin arm, risk ratio of central venous catheter-associated deep venous thrombosis was 0.55 (95% credible interval, 0.24-1.11). Including children without ultrasonography, clinically relevant central venous catheter-associated deep venous thrombosis developed in one of 27 children (3.7%) in the enoxaparin arm and seven of 24 (29.2%) in the usual care arm (p = 0.02). Clinically relevant bleeding developed in one child randomized to the enoxaparin arm. Response profile of endogenous thrombin potential, a measure of thrombin generation, was not statistically different between trial arms.
Conclusions:
These findings suggest the efficacy and safety of early prophylaxis that should be validated in a pivotal randomized clinical trial.
Related Concept Videos
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
01:30Acute Kidney Injury IV: Diagnostic Studies and Prevention
01:29Venous Thrombosis III: Interprofessional Care
01:17Pharmacokinetics in Pediatric Patients: Drug Distribution
01:29Pulmonary Embolism II: Diagnostic Studies and Interprofessional Care
01:22Healthcare Associated Infections II: Preventive Measures
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...