Clinical Trials Logo

Clinical Trial Summary

The purpose of this phase 2a, multi-center, randomized controlled study, is to explore the efficacy of early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in critically ill children.

Clinical Trial Description

Critical illness and the presence of a central venous catheter (CVC) are the most important risk factors for deep venous thrombosis (DVT) in children. Catheter-associated thrombosis (CADVT) is highly prevalent and associated with poor outcomes in critically ill children. Yet, based on underpowered pediatric trials, prophylaxis against CADVT is not recommended in children. The recommendation to provide prophylaxis against thrombosis in critically ill adults should not be applied to children because the hemostatic system and co-morbidities vastly differ between age groups. Pivotal trials are urgently needed to determine whether prophylaxis can prevent CADVT and its complications in critically ill children. However, the timing and extent of reduction in thrombin generation, the biochemical goal of prophylaxis, needed to prevent CADVT in children are unclear. The goal of this application is to explore the efficacy of early prophylaxis against CADVT in critically ill children. Aim 1 is to obtain preliminary evidence on the effect of early prophylaxis on the incidence of CADVT in critically ill children. Based on the natural history of CADVT, we hypothesize that among critically ill children, prophylaxis administered <24 hours after catheter insertion decreases the incidence of ultrasound-diagnosed CADVT compared with no prophylaxis. In this phase 2a trial, children admitted to the intensive care unit with a newly inserted central venous catheter will receive enoxaparin adjusted according to anti-Xa activity, a control group will not receive enoxaparin adjusted according to anti-Xa activity. Enoxaparin has become the "standard" pediatric anticoagulant for prophylaxis despite the absence of conclusive data. We will use Bayesian approach to determine whether further trials are warranted. Aim 2 is to evaluate the effect of an anti-Xa activity-directed prophylactic strategy on thrombin generation in critically ill children. We hypothesize that among critically ill children, standard prophylactic dose of enoxaparin adjusted by anti-Xa activity reduces thrombin generation to <700 nanomolar-minute (nM.min), as measured by endogenous thrombin potential (ETP). In non-critically ill adults, prophylactic dose of enoxaparin proven to prevent DVT reduces ETP to <700 nM.min. Endogenous thrombin potential is the best available measure of thrombin generation. We will measure endogenous thrombin potential and anti-Xa activity at multiple time points then examine their relationship in all children enrolled in the phase 2a trial. The proposed research challenges the current paradigm on prophylaxis against CADVT in children. High quality evidence is needed to prevent CADVT and its complications in this vulnerable population. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03003390
Study type Interventional
Source Yale University
Status Terminated
Phase Phase 2
Start date April 5, 2017
Completion date August 16, 2019

See also
  Status Clinical Trial Phase
Completed NCT02889562 - Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation Phase 2/Phase 3
Completed NCT00812370 - The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids Phase 1
Completed NCT01333618 - Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter N/A
Completed NCT02552420 - The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism Phase 2/Phase 3
Completed NCT00178789 - Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis Phase 1/Phase 2
Completed NCT03251963 - Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients Phase 2
Completed NCT03286985 - The Prevalence and Incidence of DVT in General ICU
Completed NCT04414332 - Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry
Completed NCT02211326 - Genotype-guided Warfarin Individualized Treatment N/A
Completed NCT03296280 - Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
Completed NCT00628576 - Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities Phase 3
Active, not recruiting NCT02318472 - Early Mobilization After Achilles Tendon Rupture N/A
Completed NCT01221805 - STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism Phase 4
Recruiting NCT03740633 - Functional Training for the Prevention of Deep Venous Thrombosis Phase 3
Completed NCT03707665 - Deep Venous Thrombosis Screening in the ICU by Nurses
Recruiting NCT01573169 - PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients Phase 3
Completed NCT01542723 - Pot-Kast: Thrombosis Prophylaxis After Knee Arthroscopy N/A
Completed NCT01140386 - Prevalence and Risk Factors of Venous Thromboembolism in Hospitalized Pediatric Patients N/A
Completed NCT00182143 - PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) Phase 3
Completed NCT00329433 - Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery Phase 2/Phase 3