Venous Thromboembolism: Enhancing Representation in Clinical Trials and Investigation of Sociodemographic and Clinical Factors Associated with Secondary Anticoagulation Use and Outcomes in Children

University Of Alabama At Birmingham, Birmingham AL

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT The rates of pediatric venous thromboembolism (VTE) have risen substantially over the last decade. Although 90% of pediatric VTE are provoked and carry a low risk for VTE recurrence (~1%), some children have a markedly higher risk for recurrence (16-29%) due to the presence of persistent prothrombotic risk factors (PPRF) after primary anticoagulant therapy. Better VTE prevention strategies are desperately needed. Unfortunately, the factors that contribute to VTE recurrence are not fully understood. Importantly, the impact of social determinants of health (SDOH) on pediatric VTE outcomes has been under studied. This proposal aims to address this critical knowledge gap by systematically analyzing VTE data derived from a multicenter prospective cohort study of pediatric VTE patients <21 years old with a first provoked VTE. The specific aims of this study are to characterize the types of PPRF after primary anticoagulant therapy (Aim1); identify risk factors (secondary anticoagulation use and SDOH) on rates of recurrent VTE one year post index VTE (Aim 2); and to identify facilitators and barriers (patient and provider) to secondary anticoagulation use and acceptability of future clinical trial participation (Aim 3). The applicant’s overarching career goal is to develop and apply field-leading expertise in the design, execution, and analysis of pragmatic clinical trials in children with VTE, with a focus on enhancing representation therein. She has designed a personalized career development plan with the overarching goal of acquiring skills to plan and conduct pediatric VTE randomized controlled trials, developing health disparities research skills to identify, and overcome barriers to care. The long-term goal for this research is to establish which children with PPRF have the highest risk of recurrent VTE and improve overall health outcomes by ushering in an era of riskstratified therapeutics in pediatric VTE management.