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https://wslhd.intersearch.com.au/wslhdjspui/handle/1/9083| Title: | Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19 |
| Authors: | McQuilten, Z. K.;Venkatesh, B.;Jha, V.;Roberts, J.;Morpeth, S. C.;Totterdell, J. A.;McPhee, G. M.;Abraham, J.;Bam, N.;Bandara, M.;Bangi, A. K.;Barina, L. A.;Basnet, B. K.;Bhally, H.;Bhusal, K. R.;Bogati, U.;Bowen, A. C.;Burke, A. J.;Christopher, D. J.;Chunilal, S. D.;Cochrane, B.;Curnow, Jennifer;Das, S. K.;Dhungana, A.;Di Tanna, G. L.;Dotel, Ravindra;Dsouza, H.;Dummer, J.;Dutta, S.;Foo, H.;Gilbey, T. L.;Giles, M. L.;Goli, K.;Gordon, A.;Gyanwali, P.;Haksar, D.;Hudson, B. J.;Jani, M. K.;Jevaji, P. R.;Jhawar, S.;Jindal, A.;John, M. J.;John, M.;John, F. B.;John, O.;Jones, M.;Joshi, R. D.;Kamath, P.;Kang, G.;Karki, A. R.;Karmalkar, A. M.;Kaur, B.;Koganti, K. C.;Koshy, J. M.;Krishnamurthy, M. S.;Lau, J. S.;Lewin, S. R.;Lim, L.;Marschner, I. C.;Marsh, J. A.;Maze, M. J.;McGree, J. M.;McMahon, J. H.;Medcalf, R. L.;Merriman, E. G.;Misal, A. P.;Mora, J. M.;Mudaliar, V. K.;Nguyen, V.;O'Sullivan, Matthew N.;Pant, S.;Pant, P.;Paterson, D. L.;Price, D. J.;Rees, M. A.;Robinson, J. O.;Rogers, B. A.;Samuel, S.;Sasadeusz, J.;Sharma, D.;Sharma, P. K.;Shrestha, R.;Shrestha, S. K.;Shrestha, P.;Shukla, U.;Shum, O.;Sommerville, C.;Spelman, T.;Sullivan, R. P.;Thatavarthi, U.;Tran, H. A.;Trask, N.;Whitehead, C. L.;Mahar, R. K.;Hammond, N. E.;McFadyen, J. D.;Snelling, T. L.;Davis, J. S.;Denholm, J. T.;Tong, S. Y. |
| WSLHD Author: | Curnow, Jennifer;Dotel, Ravindra;O'Sullivan, Matthew N. |
| Subjects: | Haematology;Infections;Facilities |
| Issue Date: | 2023 |
| Citation: | NEJM Evidence. 2(2):EVIDoa2200293, 2023 Feb |
| Abstract: | BACKGROUND: Optimal thromboprophylaxis for hospitalized patients with coronavirus disease 2019 (Covid-19) is uncertain. METHODS: In an open-label, adaptive platform trial, we randomly assigned hospitalized adults with Covid-19 to low-dose low-molecular-weight heparin thromboprophylaxis or intermediate-dose or low-dose plus aspirin. In response to external evidence, the aspirin intervention was discontinued and a therapeutic-dose arm added. The primary end point was death or the requirement for new organ support by day 28, analyzed with a Bayesian logistic model. Enrolment was closed as a result of operational constraints. RESULTS: Between February 2021 and March 2022, 1574 patients were randomly assigned. Among 1526 participants included in the analysis (India, n=1273; Australia and New Zealand, n=138; and Nepal, n=115), the primary outcome occurred in 35 (5.9%) of 596 in low-dose, 25 (4.2%) of 601 in intermediate-dose, 20 (7.2%) of 279 in low-dose plus aspirin, and 7 (14%) of 50 in therapeutic-dose anticoagulation. Compared with low-dose thromboprophylaxis, the median adjusted odds ratio for the primary outcome for intermediate-dose was 0.74 (95% credible interval [CrI], 0.43 to 1.27; posterior probability of effectiveness [adjusted odds ratio<1; Pr], 86%), for low-dose plus aspirin 0.88 (95% CrI, 0.47 to 1.64; Pr, 65%), and for therapeutic-dose anticoagulation 2.22 (95% CrI, 0.77 to 6.20; Pr, 7%). Overall thrombotic and bleeding rates were 0.8% and 0.4%, respectively. There were 10 serious adverse reactions related to anticoagulation strategy, of which nine were grade 1 or 2 across study interventions and one grade 4 episode of retroperitoneal hematoma in a patient receiving intermediate-dose anticoagulation. CONCLUSIONS: In hospitalized non�critically ill adults with Covid-19, compared with low-dose, there was an 86% posterior probability that intermediate-dose, 65% posterior probability that low-dose plus aspirin, and a 7% posterior probability that therapeutic-dose anticoagulation reduced the odds of death or requirement for organ support. No treatment strategy met prespecified stopping criteria before trial closure, precluding definitive conclusions. |
| URI: | https://wslhd.intersearch.com.au/wslhdjspui/handle/1/9083 |
| DOI: | https://doi.org/10.1056/EVIDoa2200293 |
| Journal: | NEJM Evidence |
| Type: | Journal Article |
| Study or Trial: | Randomised Controlled Trial |
| Department: | Haematology Infectious Diseases |
| Facility: | Blacktown Westmead Auburn |
| Affiliated Organisations: | Monash University, Melbourne, Australia Monash Health, Melbourne, Australia University of Queensland, Brisbane, Australia The George Institute for Global Health, Sydney, Australia The George Institute for Global Health, Delhi, Delhi, India The Wesley Hospital, Brisbane, Queensland, Australia University of New South Wales, Sydney, New South Wales, Australia Imperial College, London, England, United Kingdom Metro North Health, Brisbane, Queensland, Australia Middlemore Hospital, Auckland, North Island, New Zealand Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia Department of Infectious Diseases, The University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia Christian Medical College, Ludhiana, Punjab, India Institute of Medicine, Maharajgunj Medical Campus, Kathmandu, Bagmati, Nepal Jivanrekha Multispeciality Hospital, Pune, Maharashtra, India National Academy of Medical Sciences, Bir Hospital, Kathmandu, Bagmati, Nepal North Shore Hospital, Auckland, North Island, New Zealand Institute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Bagmati, Nepal Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia Perth Children's Hospital, Perth, Western Australia, Australia The Prince Charles Hospital, Brisbane, Queensland, Australia Christian Medical College, Vellore, Tamil Nadu, India Monash Medical Centre, Melbourne, Victoria, Australia Campbelltown Hospital, Campbelltown, New South Wales, Australia Western Sydney University, Sydney, New South Wales, Australia Westmead Hospital, Sydney, New South Wales, Australia Blacktown Hospital, Sydney, New South Wales, Australia University of Otago, Dunedin, Otago, New Zealand Dunedin Hospital, Dunedin, Otago, New Zealand Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India NSW Health Pathology, Sydney, New South Wales, Australia Wagga Wagga Base Hospital, Wagga Wagga, New South Wales, Australia Aditya Multi-speciality Hospital, Guntur, Andhra Pradesh, India Royal Prince Alfred Hospital, Newborn Care, Melbourne, Victoria, Australia ITC Hotels, Gurugram, Haryana, India Royal North Shore Hospital, Sydney, New South Wales, Australia Apex Hospitals, Jaipur, Rajasthan, India Satguru Partap Singh Hospitals, Ludhiana, Punjab, India Manipal Academy of Higher Education, Udupi, Karnataka, India Sterling Multispeciality Hospital, Pune, Maharashtra, India Samishta Hospital & Research Institute, Guntur, Andhra Pradesh, India Believers Church Medical College Hospital, Thiruvalla, Kerala, India Eastern Health, Melbourne, Victoria, Australia The Alfred Hospital, Melbourne, Victoria, Australia Queensland University of Technology, Brisbane, Queensland, Australia Core Hospital, Chakan, Maharashtra, India National Institute of Singapore, Singapore, Singapore, Singapore Melbourne School of Population & Global Health, University of Melbourne, Melbourne, Victoria, Australia Respiratory and Sleep Medicine, The Royal Melbourne Hospital, Melbourne, Victoria, Australia College of Science, Health, Engineering and Education, Discipline of Health, Murdoch University, Perth, Western Australia, Australia PathWest Laboratory Medicine, Perth, Western Australia, Australia Victorian Infectious Diseases Service, The Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia Maharaja Agrasen Superspeciality Hospital, Delhi, Delhi, India Symbiosis University Hospital & Research Centre, Pune, Maharashtra, India The Wollongong Hospital, Wollongong, New South Wales, Australia University of Wollongong, Wollongong, New South Wales, Australia Karolinska Institute, Solna, Stockholm, Sweden Burnet Institute, Melbourne, Victoria, Australia St. George Hospital, School of Clinical Medicine, UNSW Medicine & Health, Sydney, New South Wales, Australia Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia Chartered Accountants Australia and New Zealand, Perth, Western Australia, Australia The Royal Women's Hospital, The University of Melbourne, Melbourne, Victoria, Australia Murdoch Children's Research Institute, Perth, Western Australia, Australia Baker Heart and Diabetes Institute, Melbourne, Victoria, Australia University of Newcastle, Newcastle, New South Wales, Australia |
| Keywords: | COVID-19 Anticoagulants Blood Coagulation Aspirin |
| Appears in Collections: | WSLHD publications |
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