Montreal, April 17, 2023 – CanVECTOR's Clinical Trials & Shared Platforms platform recently concluded the 2022 Pilot Study Funding Competition. Following an independent evaluation by scientific and patient partner reviewers, we are pleased to announce that we've awarded $100,000 to principal investigator Federico Germini, MD - McMaster University and the team for the study titled Rivaroxaban Versus Low Molecular Weight Heparin (LMWH) for Extended Venous Thromboembolism (VTE) Prophylaxis After Hip Fracture Surgery: a Pilot Randomized Trial.
About the Pilot Study
Each year, nearly 30,000 Canadians have hip fractures, and due to immobility, surgery, and concomitant diseases, these patients are at risk of VTE. Current guidelines suggest using low-molecular-weight heparin for two to four weeks in this population, with very low certainty of the evidence. While there is plenty of data on how to prevent clots in people undergoing an elective hip replacement, there is little research in people receiving urgent surgery for a hip fracture. The possibility to use oral blood thinners is appealing, as it would save patients the inconvenience of injections and the need for a caregiver if they are not able or willing to inject themselves. Additionally, oral blood thinners cost considerably less, resulting in significant cost savings for our health system. As such, a randomized controlled trial in this specific population is the best way to answer the question if direct oral anticoagulants (DOACs) are as safe and effective as injectable LMWHs.
In this pilot study, patients undergoing surgery for a hip fracture will be randomized at four Canadian centres to receive oral rivaroxaban 10 mg once daily or injectable dalteparin 5000 international units for 30 days for VTE prevention. In this randomized, open-label pilot trial with blinded central outcome adjudication, the primary feasibility outcome is patient recruitment over 8 months. Clinical and patient-reported outcomes measured during 90-day follow-up will be symptomatic VTE (deep vein thrombosis - DVT and/or pulmonary embolism - PE), bleeding, cardiovascular mortality, myocardial infarction, stroke, and quality of life.
Research Team
Led by Dr. Federico Germini, an Emergency Medicine / Thrombosis physician and Assistant professor at McMaster University, the multidisciplinary research team of experts in the fields of emergency medicine, thrombosis, epidemiology, biostatistics, and health research methodology includes Jeff Weitz, Rakeeb Choudhury, Vinai Bhagirath, Flavia Borges, Noel Chan, Kerstin de Wit, Peter Gross, Rick Ikesaka, Maura Marcucci, Sameer Parpia, and Lehana Thabane. A CanVECTOR Patient Partner will soon join the team.
Sites participating in the study are Juravinski Hospital, Hamilton General Hospital, and St. Joseph's Healthcare in Hamilton, Ontario, and Kingston General Hospital in Kingston, Ontario.
About the Pilot Study Funding Competition
The Pilot Study Funding Competition is an annual CanVECTOR funding competition aiming to build research capacity related to VTE and to enable CanVECTOR scientists to collect pilot data that will inform the conduct of larger multicentre clinical trials and increase the ability to attract external peer-reviewed funding.
CanVECTOR thanks all applicants and reviewers in this year's competition.
Dr. Deborah Siegal and Dr. Leslie Skeith
Clinical Trials & Shared Platforms, CanVECTOR