The Risk of Upper Extremity Deep Vein Thrombosis and Primary Thromboprophylaxis with Low Dose Rivaroxaban in Oncology Patients with Central Venous Catheters

Abstract

Venous thromboembolism (VTE) is a common disorder which causes significant morbidity and mortality. Upper extremity deep vein thrombosis(UEDVT) is a relatively understudied subtype of VTE which is commonly associated with central venous catheters, cancer, and thrombophilia.

The goal of this project was to better characterize the risk of UEDVT and to design and execute a pilot study that will demonstrate the efficacy of a strategy preventing the occurrence of VTE in a high-risk population for UEDVT.

This M.Sc project, was conducted in three parts. Chapter 1 of the thesis outlines a systematic review of the literature which assessed the risk of VTE in UEDVT patients by search for and including data from studies with patients with prospectively enrolled symptomatic UEDVT. Chapter 2 describes the development and final protocol of the TRIM-Line pilot study, a randomized open-label study comparing 90 days of rivaroxaban 10mg po daily against the current standard of care (observation) in patients with active cancer and central venous catheters, two known risk factors for VTE. Finally in Chapter 3 the TRIM-Line study was executed as a pilot trial involving The Ottawa Hospital and the Juravinski Cancer Centre located in Hamilton. The study was conducted from March 2019 until February 2020. 105 patients underwent randomization at the two Canadian centres. The study met its prespecified feasibility endpoint average enrolment rate of 7.5 per month (95% CI:4.56, 10.44) at the coordinating Ottawa Hospital site and 2.0 per month (95% CI:0.87, 3.13) for the Juravinski Cancer Centre site. The randomized controlled trial met its enrollment targets and demonstrated that a full scale randomized controlled trial on the topic of prevention of cancer associated venous thromboembolism is feasible.