| Study characteristics |
| Methods |
Study design: prospective cohort Type of publication: preprint available, accepted for publication in BMJ Setting and dates: hospital, 1 March 2020‐31 July 2020 Country: USA Language: English Number of centres: 1200 points of care nationwide Trial registration number: NR |
| Participants |
Number of participants: 4297 allocated (intervention = 3627; comparator = 670) Age, years (mean ± SD): 67.03 ± 12.31 (experimental), 67.83 ± 13.74 (comparator) Gender (male/female): 3395/232 (experimental), 620/50 (comparator) Comorbidities (experimental/comparator): acute myocardial infarction 1.8%/1.6%, asthma 4.9%/4.9%, cancer 13.6%/14.5%, cerebrovascular disease 10.2%/12.7%, CKD 19.1%/20.3%, COPD 15%/15.7%, coronary artery disease 2.5%/3.7%, dementia 10.4%/15.5%, diabetes 43.4%/40.1%, heart failure 10.3%/11.5%, hypertension 68.1%/66.6%, liver disease 8.9%/10.6%, peripheral arterial disease 10.7%/10.4% Confounding factors (experimental/comparator): prior anticoagulation (NR, but therapeutic anticoagulation was excluded), surgery (NR), cancer 13.6%/14.5% (adjusted), antiplatelet use (NR), history of VTE (NR) Type of ventilator support: NR
Inclusion criteria
Exclusion criteria
Patients who had no history of care (defined as at least one outpatient or inpatient encounter in the two years prior to 1 March 2020 Received therapeutic anticoagulation in the 30 days prior to hospital admission Received a red blood cell transfusion with 24 h of admission Experienced any of the primary outcomes (i.e. died or initiated therapeutic anticoagulation) within 24 h of admission and therefore did not have equal chance to be classified as exposed in this study
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| Interventions |
Experimental: prophylactic doses of subcutaneous UFH (5000 IU twice or three times/day (1094 participants = 30.2%), LMWH (enoxaparin 40 mg once or twice daily (2506 participants = 69.1%), fondaparinux 2.5 mg once daily (4 participants = 0.1%), dalteparin 2500‐5000 IU once daily, all subcutaneously) or DOACs (apixaban 2.5 mg bid (21 participants = 0.6%), rivaroxaban 10 mg once daily or 2.5 mg twice daily (2 participants = 0.1%), dabigatran 220 mg once daily, all orally) Comparator: without anticoagulation Concomitant therapy (experimental/comparator): dexamethasone 16.2%/11.0%, remdesivir 12.0%/5.2% Duration of follow‐up: up to 30 days after hospitalisation |
| Outcomes |
Primary outcomes
Secondary outcomes
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| Notes |
Sponsor/funding: quote "This work was supported by the National Institute on Alcohol Abuse and Alcoholism (U01‐AA026224, U24‐AA020794, U01‐AA020790, U10‐AA013566), and by the Department of Veterans Affairs Health Services Research & Development (C19 20‐405) and Office of Research and Development (MVP000). Funders had no role in the study design, collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. The views and opinions expressed in this manuscript are those of the authors and do not necessarily represent those of the Department of Veterans Affairs or the United States Government. COIs: quote "JAB reports consulting with Amgen, Bayer, JanOne, and Janssen. He serves on the Data Safety Monitoring Committee for Novartis. PMH is supported by grants from National Heart, Lung, and Blood Institute, VA Health Services Research & Development, and University of Colorado School of Medicine. He has a research agreement with Bristol‐Myers Squibb through the University of Colorado. He serves as the Deputy Editor for Circulation: Cardiovascular Quality and Outcomes. IJD reports grants from UK National Health Service National Institute for Health Research, and has received unrestricted research grants and holds shares in GlaxoSmithKline, outside of the submitted work. All other authors declare no conflicts of interests." Protocol not available |
