American Society of Hematology 2021 guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19
Tóm tắt
Coronavirus disease 2019 (COVID-19)–related critical illness and acute illness are associated with a risk of venous thromboembolism (VTE).
These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in decisions about the use of anticoagulation for thromboprophylaxis for patients with COVID-19–related critical illness and acute illness who do not have confirmed or suspected VTE.
ASH formed a multidisciplinary guideline panel and applied strict management strategies to minimize potential bias from conflicts of interest. The panel included 3 patient representatives. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic evidence reviews (up to 19 August 2020). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, including GRADE Evidence-to-Decision frameworks, to assess evidence and make recommendations, which were subject to public comment.
The panel agreed on 2 recommendations. The panel issued conditional recommendations in favor of prophylactic-intensity anticoagulation over intermediate-intensity or therapeutic-intensity anticoagulation for patients with COVID-19–related critical illness or acute illness who do not have confirmed or suspected VTE.
These recommendations were based on very low certainty in the evidence, underscoring the need for high-quality, randomized controlled trials comparing different intensities of anticoagulation. They will be updated using a living recommendation approach as new evidence becomes available.
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Tài liệu tham khảo
Connors, 2020, COVID-19 and its implications for thrombosis and anticoagulation, Blood, 135, 2033, 10.1182/blood.2020006000
Zhou, 2020, Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study, Lancet, 395, 1054, 10.1016/S0140-6736(20)30566-3
Tang, 2020, Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia, J Thromb Haemost, 18, 844, 10.1111/jth.14768
Guan, 2020, Clinical characteristics of coronavirus disease 2019 in China, N Engl J Med, 382, 1708, 10.1056/NEJMoa2002032
Nopp, 2020, Risk of venous thromboembolism in patients with COVID-19: a systematic review and meta-analysis, Res Pract Thromb Haemost, 4, 1178, 10.1002/rth2.12439
Institute of Medicine Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, 2011, Clinical Practice Guidelines We Can Trust
Schünemann, 2015, Guidelines International Network: principles for disclosure of interests and management of conflicts in guidelines, Ann Intern Med, 163, 548, 10.7326/M14-1885
Qaseem, 2012, Guidelines International Network: toward international standards for clinical practice guidelines, Ann Intern Med, 156, 525, 10.7326/0003-4819-156-7-201204030-00009
Alonso-Coello, 2016, GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction, BMJ, 353, i2016, 10.1136/bmj.i2016
Alonso-Coello, 2016, GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines, BMJ, 353, i2089, 10.1136/bmj.i2089
Atkins, 2004, Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group, BMC Health Serv Res, 4, 38, 10.1186/1472-6963-4-38
Schünemann, 2003, Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations, CMAJ, 169, 677
Schünemann, 2017, GRADE Evidence to Decision (EtD) frameworks for adoption, adaptation, and de novo development of trustworthy recommendations: GRADE-ADOLOPMENT, J Clin Epidemiol, 81, 101, 10.1016/j.jclinepi.2016.09.009
Guyatt, 2011, GRADE guidelines: 2. Framing the question and deciding on important outcomes, J Clin Epidemiol, 64, 395, 10.1016/j.jclinepi.2010.09.012
Guyatt, 2008, GRADE: an emerging consensus on rating quality of evidence and strength of recommendations, BMJ, 336, 924, 10.1136/bmj.39489.470347.AD
Johns Hopkins University & Medicine. Coronavirus Resource Center. https://coronavirus.jhu.edu/map.html. Accessed 28 October 2020.
Cummings, 2020, Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study, Lancet, 395, 1763, 10.1016/S0140-6736(20)31189-2
Government of Canada. Coronavirus Disease 2019 (COVID-19): Epidemiology Update. https://health-infobase.canada.ca/covid-19/epidemiological-summary-covid-19-cases.html#a7. Accessed 10 October 2020.
Grasselli, 2020, Critical care utilization for the COVID-19 outbreak in Lombardy, Italy: early experience and forecast during an emergency response, JAMA, 323, 1545, 10.1001/jama.2020.4031
Helms, 2020, High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study, Intensive Care Med, 46, 1089, 10.1007/s00134-020-06062-x
Middeldorp, 2020, Incidence of venous thromboembolism in hospitalized patients with COVID-19, J Thromb Haemost, 18, 1995, 10.1111/jth.14888
Klok, 2020, Incidence of thrombotic complications in critically ill ICU patients with COVID-19, Thromb Res, 191, 145, 10.1016/j.thromres.2020.04.013
Cui, 2020, Prevalence of venous thromboembolism in patients with severe novel coronavirus pneumonia, J Thromb Haemost, 18, 1421, 10.1111/jth.14830
Santoliquido, 2020, Incidence of deep vein thrombosis among non-ICU patients hospitalized for COVID-19 despite pharmacological thromboprophylaxis, J Thromb Haemost, 18, 2358, 10.1111/jth.14992
Llitjos, 2020, High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients, J Thromb Haemost, 18, 1743, 10.1111/jth.14869
Fara, 2020, Macrothrombosis and stroke in patients with mild Covid-19 infection, J Thromb Haemost, 18, 2031, 10.1111/jth.14938
Fan, 2020, Neurological manifestations in critically ill patients with COVID-19: a retrospective study, Front Neurol, 11, 806, 10.3389/fneur.2020.00806
Fox, 2020, Pulmonary and cardiac pathology in African American patients with COVID-19: an autopsy series from New Orleans, Lancet Respir Med, 8, 681, 10.1016/S2213-2600(20)30243-5
Wichmann, 2020, Autopsy findings and venous thromboembolism in patients with COVID-19: a prospective cohort study, Ann Intern Med, 173, 268, 10.7326/M20-2003
Ooi, 2020, Pulmonary thromboembolic disease in COVID-19 patients on CT pulmonary angiography - prevalence, pattern of disease and relationship to D-dimer, Eur J Radiol, 132, 109336, 10.1016/j.ejrad.2020.109336
van Dam, 2020, Clinical and computed tomography characteristics of COVID-19 associated acute pulmonary embolism: A different phenotype of thrombotic disease?, Thromb Res, 193, 86, 10.1016/j.thromres.2020.06.010
Teuwen, 2020, COVID-19: the vasculature unleashed. [published correction appears in Nat Rev Immunol. 2020;20(7):448], Nat Rev Immunol, 20, 389, 10.1038/s41577-020-0343-0
Goshua, 2020, Endotheliopathy in COVID-19-associated coagulopathy: evidence from a single-centre, cross-sectional study, Lancet Haematol, 7, e575, 10.1016/S2352-3026(20)30216-7
Ren, 2020, Extremely high incidence of lower extremity deep venous thrombosis in 48 patients with severe COVID-19 in Wuhan, Circulation, 142, 181, 10.1161/CIRCULATIONAHA.120.047407
Al-Samkari, 2020, COVID-19 and coagulation: bleeding and thrombotic manifestations of SARS-CoV-2 infection, Blood, 136, 489, 10.1182/blood.2020006520
Mouhat, 2020, Elevated D-dimers and lack of anticoagulation predict PE in severe COVID-19 patients, Eur Respir J, 56, 2001811, 10.1183/13993003.01811-2020
Paranjpe, 2020, Association of treatment dose anticoagulation with in-hospital survival among hospitalized patients with COVID-19, J Am Coll Cardiol, 76, 122, 10.1016/j.jacc.2020.05.001
Schünemann, 2018, American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients, Blood Adv, 2, 3198, 10.1182/bloodadvances.2018022954
Barbar, 2010, A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score, J Thromb Haemost, 8, 2450, 10.1111/j.1538-7836.2010.04044.x
Kahn, 2012, Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines, Chest, 141, e195S, 10.1378/chest.11-2296
National Institutes of Health. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. https://www.covid19treatmentguidelines.nih.gov/. Accessed 10 October 2020.
Geerts, 2006, Prevention of venous thromboembolism in high-risk patients, Hematology Am Soc Hematol Educ Program, 2006, 462, 10.1182/asheducation-2006.1.462
Spyropoulos, 2011, Predictive and associative models to identify hospitalized medical patients at risk for VTE, Chest, 140, 706, 10.1378/chest.10-1944
Decousus, 2011, Factors at admission associated with bleeding risk in medical patients: findings from the IMPROVE investigators, Chest, 139, 69, 10.1378/chest.09-3081
Darzi, 2020, Risk-assessment models for VTE and bleeding in hospitalized medical patients: an overview of systematic reviews, Blood Adv, 4, 4929, 10.1182/bloodadvances.2020002482
Wiercioch, 2020, Methodology for the American Society of Hematology VTE guidelines: current best practice, innovations, and experiences, Blood Adv, 4, 2351, 10.1182/bloodadvances.2020001768
Guyatt, 2011, GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables, J Clin Epidemiol, 64, 383, 10.1016/j.jclinepi.2010.04.026
Akl, 2017, Living systematic reviews: 4. Living guideline recommendations, J Clin Epidemiol, 91, 47, 10.1016/j.jclinepi.2017.08.009
Simmonds, 2017, Living systematic reviews: 3. Statistical methods for updating meta-analyses, J Clin Epidemiol, 91, 38, 10.1016/j.jclinepi.2017.08.008
Thomas, 2017, Living systematic reviews: 2. Combining human and machine effort, J Clin Epidemiol, 91, 31, 10.1016/j.jclinepi.2017.08.011
Schünemann, 2016, GRADE guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health, J Clin Epidemiol, 76, 89, 10.1016/j.jclinepi.2016.01.032
Schünemann, 2014, Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise, CMAJ, 186, E123, 10.1503/cmaj.131237
Chen, 2017, A reporting tool for practice guidelines in health care: the RIGHT statement, Ann Intern Med, 166, 128, 10.7326/M16-1565
Institute of Medicine Committee on Conflict of Interest in Medical Research, Education, and Practice, 2009, Conflict of Interest in Medical Research, Education, and Practice
Schünemann H , BrozekJ, GuyattG, OxmanA, eds. Handbook for Grading the Quality of Evidence and the Strength of Recommendations Using the GRADE Approach. Updated October 2013. http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html. Accessed 1 November 2020.
Schünemann HJ . Getting trustworthy guideline recommendations into practice. The BMJ Opinion (https://blogs.bmj.com/bmj/2018/12/31/holger-j-schunemann-getting-trustworthy-guideline-recommendations-into-practice/). 31 December 2018. Accessed 1 November 2020.
Bates, 2018, American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy, Blood Adv, 2, 3317, 10.1182/bloodadvances.2018024802
Cuker, 2018, American Society of Hematology 2018 guidelines for management of venous thromboembolism: heparin-induced thrombocytopenia, Blood Adv, 2, 3360, 10.1182/bloodadvances.2018024489
Lim, 2018, American Society of Hematology 2018 guidelines for management of venous thromboembolism: diagnosis of venous thromboembolism, Blood Adv, 2, 3226, 10.1182/bloodadvances.2018024828
Witt, 2018, American Society of Hematology 2018 guidelines for management of venous thromboembolism: optimal management of anticoagulation therapy, Blood Adv, 2, 3257, 10.1182/bloodadvances.2018024893
Anderson, 2019, American Society of Hematology 2019 guidelines for management of venous thromboembolism: prevention of venous thromboembolism in surgical hospitalized patients, Blood Adv, 3, 3898, 10.1182/bloodadvances.2019000975
Ortel, 2020, American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism, Blood Adv, 4, 4693, 10.1182/bloodadvances.2020001830
Monagle, 2018, American Society of Hematology 2018 Guidelines for management of venous thromboembolism: treatment of pediatric venous thromboembolism, Blood Adv, 2, 3292, 10.1182/bloodadvances.2018024786
Elliott, 2017, Living systematic review: 1. Introduction-the why, what, when, and how, J Clin Epidemiol, 91, 23, 10.1016/j.jclinepi.2017.08.010
Izcovich, 2020, A user guide to the American Society of Hematology clinical practice guidelines, Blood Adv, 4, 2095, 10.1182/bloodadvances.2020001755
Fraissé, 2020, Thrombotic and hemorrhagic events in critically ill COVID-19 patients: a French monocenter retrospective study, Crit Care, 24, 275, 10.1186/s13054-020-03025-y
Trigonis, 2020, Incidence of venous thromboembolism in critically ill coronavirus disease 2019 patients receiving prophylactic anticoagulation, Crit Care Med, 48, e805, 10.1097/CCM.0000000000004472
Taccone, 2020, Higher intensity thromboprophylaxis regimens and pulmonary embolism in critically ill coronavirus disease 2019 patients, Crit Care Med, 48, e1087, 10.1097/CCM.0000000000004548
Lauzier, 2013, Risk factors and impact of major bleeding in critically ill patients receiving heparin thromboprophylaxis, Intensive Care Med, 39, 2135, 10.1007/s00134-013-3044-3
Anand, 2003, Relationship of activated partial thromboplastin time to coronary events and bleeding in patients with acute coronary syndromes who receive heparin, Circulation, 107, 2884, 10.1161/01.CIR.0000077530.53367.E9
Koch, 1997, Low molecular weight heparin and unfractionated heparin in thrombosis prophylaxis after major surgical intervention: update of previous meta-analyses, Br J Surg, 84, 750
Schulman, 2008, Hemorrhagic complications of anticoagulant and thrombolytic treatment: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition), Chest, 257S
Huang, 2018, Secular trends and etiologies of venous thromboembolism in Chinese from 2004 to 2016, Thromb Res, 166, 80, 10.1016/j.thromres.2018.04.021
Cheuk, 2004, Epidemiology of venous thromboembolism in a Chinese population, Br J Surg, 91, 424, 10.1002/bjs.4454
Miranda, 2017, Adjusted value of thromboprophylaxis in hospitalized obese patients: a comparative study of two regimens of enoxaparin: the ITOHENOX study, Thromb Res, 155, 1, 10.1016/j.thromres.2017.04.011
Rondina, 2010, Weight-based dosing of enoxaparin for VTE prophylaxis in morbidly obese, medically-Ill patients, Thromb Res, 125, 220, 10.1016/j.thromres.2009.02.003
Castellucci, 2016, Determining the safety of enoxaparin prophylaxis in critically ill patients with severe renal insufficiency - the PACER pilot study, Thromb Res, 144, 69, 10.1016/j.thromres.2016.05.026
Douketis, 2008, Prophylaxis against deep vein thrombosis in critically ill patients with severe renal insufficiency with the low-molecular-weight heparin dalteparin: an assessment of safety and pharmacodynamics: the DIRECT study, Arch Intern Med, 168, 1805, 10.1001/archinte.168.16.1805
Mahé, 2007, Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function: a comparative pharmacokinetic study, Thromb Haemost, 97, 581, 10.1160/TH06-09-0513
Martin, 2020, Gastrointestinal bleeding in patients with coronavirus disease 2019: a matched case-control study, Am J Gastroenterol, 115, 1609, 10.14309/ajg.0000000000000805
Pesavento, 2020, The hazard of (sub)therapeutic doses of anticoagulants in non-critically ill patients with Covid-19: the Padua province experience, J Thromb Haemost, 18, 2629, 10.1111/jth.15022
Nadkarni, 2020, Anticoagulation, bleeding, mortality, and pathology in hospitalized patients with COVID-19, J Am Coll Cardiol, 76, 1815, 10.1016/j.jacc.2020.08.041
Spyropoulos, 2020, Scientific and Standardization Committee communication: clinical guidance on the diagnosis, prevention, and treatment of venous thromboembolism in hospitalized patients with COVID-19, J Thromb Haemost, 18, 1859, 10.1111/jth.14929
Barnes, 2020, Thromboembolism and anticoagulant therapy during the COVID-19 pandemic: interim clinical guidance from the anticoagulation forum, J Thromb Thrombolysis, 50, 72, 10.1007/s11239-020-02138-z
Moores, 2020, Prevention, diagnosis, and treatment of VTE in patients with coronavirus disease 2019: CHEST Guideline and Expert Panel Report, Chest, 158, 1143, 10.1016/j.chest.2020.05.559
Bikdeli, 2020, COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up: JACC State-of-the-Art Review, J Am Coll Cardiol, 75, 2950, 10.1016/j.jacc.2020.04.031
Wang, 2020, Tissue plasminogen activator (tPA) treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): a case series, J Thromb Haemost, 18, 1752, 10.1111/jth.14828
Obi, 2019, Empirical systemic anticoagulation is associated with decreased venous thromboembolism in critically ill influenza A H1N1 acute respiratory distress syndrome patients [published correction appears in J Vasc Surg Venous Lymphat Disord. 2019;7(4):621], J Vasc Surg Venous Lymphat Disord, 7, 317, 10.1016/j.jvsv.2018.08.010
Walker, 2017, Increased enoxaparin dosing for venous thromboembolism prophylaxis in general trauma patients, Ann Pharmacother, 51, 323, 10.1177/1060028016683970
Ikesaka, 2014, Efficacy and safety of weight-adjusted heparin prophylaxis for the prevention of acute venous thromboembolism among obese patients undergoing bariatric surgery: a systematic review and meta-analysis, Thromb Res, 133, 682, 10.1016/j.thromres.2014.01.021
Arabi, 2019, Adjunctive intermittent pneumatic compression for venous thromboprophylaxis, N Engl J Med, 380, 1305, 10.1056/NEJMoa1816150
Tang, 2020, Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy, J Thromb Haemost, 18, 1094, 10.1111/jth.14817