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.

Autor:	Sidhu VS; CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia verinder.s.sidhu@gmail.com., Graves SE; Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia., Buchbinder R; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.; Monash Department of Clinical Epidemiology, Cabrini Institute, Melbourne, Victoria, Australia., Naylor JM; CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia., Pratt NL; School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia., de Steiger RS; Department of Surgery, Epworth Healthcare, University of Melbourne, Melbourne, Victoria, Australia., Chong BH; Department of Haematology, Saint George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia., Ackerman IN; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia., Adie S; Faculty of Medicine, Saint George and Sutherland Clinical School, University of New South Wales, Sydney, New South Wales, Australia., Harris A; Monash University Centre for Health Economics, Caufield, Victoria, Australia., Hansen A; CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia., Cripps M; CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia., Lorimer M; South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia., Webb S; Department of Intensive Care, St John of God Hospital, Subiaco, Western Australia, Australia.; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Austria., Clavisi O; Musculoskeletal Australia, Melbourne, Victoria, Australia., Griffith EC; South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia., Anandan D; Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia., O'Donohue G; Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia., Kelly TL; School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, South Australia, Australia., Harris IA; CRISTAL Study Group, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia.; Institute for Musculoskeletal Health, The University of Sydney School of Public Health, Sydney, New South Wales, Australia.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2019 Nov 06; Vol. 9 (11), pp. e031657. Date of Electronic Publication: 2019 Nov 06.
DOI:	10.1136/bmjopen-2019-031657
Abstrakt:	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 comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals. Ethics and Dissemination: Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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