CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study
Verinder Singh Sidhu, Steven E Graves, Rachelle Buchbinder, Justine Maree Naylor, Nicole L Pratt, Richard S de Steiger, Beng H Chong, Ilana N Ackerman, Sam Adie, Anthony Harris, Amber Hansen, Maggie Cripps, Michelle Lorimer, Steve Webb, Ornella Clavisi, Elizabeth C Griffith, Durga Anandan, Grace O'Donohue, Thu-Lan Kelly, Ian A Harris
BMJ OPEN | BMJ PUBLISHING GROUP | Published : 2019
INTRODUCTION: Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA. METHODS AND ANALYSIS: This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150 mg daily. The compa..View full abstract
The study is being funded by a 4-year Medical Research Futures Fund (Australian Federal Government) grant.