- Title
- Anticoagulation Strategies in Non-Critically Ill Patients with Covid-19
- Creator
- McQuilten, Zoe K.; Venkatesh, Balasubramanian; Bangi, Ashpak K.; Barina, Lauren A.; Basnet, Bhupendra K.; Bhally, Hasan; Bhusal, Khema R.; Bogati, Umesh; Bowen, Asha C.; Burke, Andrew J.; Christopher, Devasahayam J.; Chunilal, Sanjeev D.; Jha, Vivekanand; Cochrane, B; Curnow, JL; Das, SK; Dhungana, A; Di Tanna, GL; Dotel, R; DSouza, H; Dummer, J; Dutta, S; Foo, H; Roberts, Jason; Gilbey, TL; Giles, ML; Goli, K; Gordon, A; Gyanwali, P; Haksar, D; Hudson, BJ; Jani, MK; Jevaji, PR; Jhawar, S; Morpeth, Susuan C.; Jindal, A; John, MJ; John, M; John, FB; John, O; Jones, M; Joshi, RD; Kamath, P; Kang, G; Karki, AR; Totterdell, James A.; Karmalkar, AM; Kaur, B; Koganti, KC; Koshy, JM; Krishnamurthy, MS; Lau, JS; Lewin, SR; Lim, L-L; Marschner, IC; Marsh, JA; McPhee, Grace M.; Maze, MJ; McGree, JM; McMahon, JH; Medcalf, RL; Merriman, EG; Misal, AP; Mora, JM; Mudaliar, VK; Nguyen, V; O'Sullivan, MV; Abraham, John; Pant, S; Pant, P; Paterson, DL; Price, DJ; Rees, MA; Robinson, JO; Rogers, BA; Samuel, S; Sasadeusz, J; Sharma, D; Bam, Niraj; Sharma, PK; Shrestha, R; Shrestha, SK; Shrestha, P; Shukla, U; Shum, O; Sommerville, C; Spelman, T; Sullivan, RP; Thatavarthi, U; Bandara, Methma; Tran, HA; Trask, N; Whitehead, CL; Mahar, RK; Hammond, NE; McFadyen, JD; Snelling, TL; Davis, Joshua S.; Denholm, JT; Tong, SYC
- Relation
- NEJM evidence Vol. 2, Issue 2
- Publisher Link
- http://dx.doi.org/10.1056/evidoa2200293
- Publisher
- Massachusetts Medical Society
- Resource Type
- journal article
- Date
- 2023
- Description
- 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.
- Subject
- optimal thromboprophylaxis; hospitalized patients; covid-19; adaptive platform trial
- Identifier
- http://hdl.handle.net/1959.13/1504195
- Identifier
- uon:55471
- Identifier
- ISSN:2766-5526
- Language
- eng
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