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Pediatric Epidemiology and Interventions against THromboembolic Outcomes (PEITHO) Program

About Us

The rate of venous thromboembolism, which is composed primarily of deep venous thrombosis and pulmonary embolism, is increasing in children. Advances in medical care, improved survival of children with life-threatening or chronic diseases, and increased awareness contribute to the increasing rate. Venous thromboembolism is potentially preventable in children, as it is in adults. However, paucity of pediatric data has limited the ability to prevent these events from occurring in children.

The goal of the PEITHO Program is to develop evidence-based strategies that will prevent venous thromboembolism in children. The program is dedicated to conducting innovative pediatric multicenter observational studies that define the epidemiology of venous thromboembolism, and interventional trials of preventive approaches against venous thromboembolism.

Proposed Projects

Anti-THrombosis with Enoxaparin in iNtubated Adolescents (ATHENA) Trial

The goal of this innovative Bayesian adaptive, Goldilocks, parallel-cohort randomized clinical trial is to determine the efficacy of enoxaparin in reducing the risk of radiologically diagnosed lower extremity deep venous thrombosis in mechanically ventilated adolescents.

Adolescent Thromboprophylaxis after Traumatic Injury or Surgery (ATTIS) Trial

The goal of this trial will be to determine the efficacy of pharmacologic prophylaxis in reducing the risk of deep venous thrombosis in adolescents recovering from trauma or surgery.

Ongoing Projects

Catheter-Related Early Thromboprophylaxis with Enoxaparin (CRETE) Trial

The goal of this innovative Bayesian, single arm, phase 2a trial is to explore the efficacy of early prophylaxis against catheter-associated deep venous thrombosis in critically ill children.

THrombosis Epidemiology in Ill Adolescents (THEIA) Study

The goal of this multicenter cohort study is to determine the frequency and outcomes of, and risk factors for deep venous thrombosis in critically ill adolescents.

ATHENA Trial

Venous thromboembolism (VTE), composed mainly of deep venous thrombosis (DVT) and pulmonary embolism, is a top contributor to harm in hospitalized children. Critically ill adolescents are at high risk of VTE. Studies indicate that in addition to hypercoagulability, endothelial injury and venous stasis from central venous catheters are key determinants of DVT in critically ill adolescents. The appropriate strategy to prevent VTE in these adolescents is unknown. This results in wide variation in practice, low use of thromboprophylaxis, and increasing incidence of VTE in adolescents. Due to lack of pediatric-specific evidence, thromboprophylaxis practice in critically ill adolescents is extrapolated from adults. Pediatric patient safety initiatives recommend mechanical thromboprophylaxis (mTP) for these adolescents to account for the unique differences in the epidemiology of VTE in adolescents. Given the efficacy of pharmacological thromboprophylaxis (pTP) in adults, the pediatric initiatives recommend strongly considering combined mTP and pTP (mTP+pTP), which likely attenuates venous stasis from a central venous catheter and hypercoagulability. Yet, between mTP+pTP and mTP alone, the American Society of Hematology in 2018 has suggested using mTP alone for medical inpatients because of uncertainty in the net clinical benefit of mTP+pTP with harm likely outweighing benefits. With the support of the PALISI Network, the Adjunctive THromboprophylaxis with Enoxaparin in iNtubated Adolescents (ATHENA) Trial will test the central hypothesis is that mTP+pTP safely reduces the risk of VTE in critically ill adolescents over mTP alone. It will provide much needed pediatric-specific evidence that will inform clinical practice. It will also enhance our understanding of the pathophysiology of VTE in critically ill adolescents.

Completed Projects

Identification of critically ill children at high risk of central venous catheter-related deep venous thrombosis

The goal of this cohort study is to assess whether plasma biomarkers measured soon after insertion of a central venous catheter can be used to identify critically ill children who are at high risk of catheter-associated deep venous thrombosis.

PROphylaxis against ThRombosis prACTice (PROTRACT) Study

The goal of this multinational cross-sectional study is to characterize thromboprophylaxis practice in critically ill children.

Epidemiology of central venous catheter-associated deep venous thrombosis in critically ill children

The goal of this multicenter cohort study is to determine the frequency and outcomes of, and risk factors for central venous catheter-associated deep venous thrombosis in critically ill children.

Program Members

Publications