Abstract
Original language | English |
---|---|
Article number | 102142 |
Journal | Research and practice in thrombosis and haemostasis |
Volume | 7 |
Issue number | 5 |
DOIs | |
Publication status | Published - 1 Jul 2023 |
Keywords
- COVID-19
- SARS-CoV-2
- developing countries
- disseminated intravascular coagulation
- hemorrhage
- ischemic stroke
- thromboembolism
- thrombosis
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In: Research and practice in thrombosis and haemostasis, Vol. 7, No. 5, 102142, 01.07.2023.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Thrombotic and hemorrhagic complications of COVID-19 in adults hospitalized in high-income countries compared with those in adults hospitalized in low- and middle-income countries in an international registry
AU - Griffee, Matthew J.
AU - Bozza, Patricia T.
AU - ISARIC clinical characterisation group
AU - Reyes, Luis Felipe
AU - Eddington, Devin P.
AU - Rosenberger, Dorothea
AU - Merson, Laura
AU - Citarella, Barbara Wanjiru
AU - Fanning, Jonathon P.
AU - Alexander, Peta M. A.
AU - Fraser, John
AU - Dalton, Heidi
AU - Cho, Sung-Min
AU - Abdukahil, Sheryl Ann
AU - Abdulkadir, Nurul Najmee
AU - Abe, Ryuzo
AU - Abel, Laurent
AU - Abrous, Amal
AU - Absil, Lara
AU - Acker, Andrew
AU - Adam, Elisabeth
AU - Adrião, Diana
AU - Al Ageel, Saleh
AU - Ahmed, Shakeel
AU - Ainscough, Kate
AU - Aisa, Tharwat
AU - Hssain, Ali Ait
AU - Tamlihat, Younes Ait
AU - Akimoto, Takako
AU - Akmal, Ernita
AU - Akwani, Chika
AU - Al Qasim, Eman
AU - Alalqam, Razi
AU - Beane, Abigail
AU - Blot, Mathieu
AU - Cristella, Cosimo
AU - Croonen, Sabine
AU - de Jong, Menno
AU - de Vries, Peter
AU - Janes, Victoria
AU - Nguyen, Duc
AU - Paxton, William A.
AU - Pollakis, Georgios
AU - Scicluna, Brendan
AU - Neto, Ary Serpa
AU - Stienstra, Ymkje
AU - van der Valk, Paul
AU - van Gulik, Laura
AU - van Hattem, Jarne
AU - van Someren Gréve, Frank
AU - van Willigen, Hugo
N1 - Funding Information: This work was made possible by the UK Foreign, Commonwealth and Development Office and Wellcome (215091/Z/18/Z, 222410/Z/21/Z, 225288/Z/22/Z and 220757/Z/20/Z); the Bill & Melinda Gates Foundation (OPP1209135); philanthropic support of the donors to the University of Oxford’s COVID-19 Research Response Fund (0009109); CIHR Coronavirus Rapid Research Funding Opportunity OV2170359 and coordination in Canada by Sunnybrook Research Institute; funding by the Health Research Board of Ireland (CTN-2014-12); Rapid European COVID-19 Emergency Response research (H2020 project 101003589) and European Clinical Research Alliance on Infectious Diseases (965313); the Research Council of Norway grant no 312780, and a philanthropic donation from Vivaldi Invest A/S owned by Jon Stephenson von Tetzchner; the Comprehensive Local Research Networks, of which PJMO is an NIHR Senior Investigator (NIHR201385); Innovative Medicines Initiative Joint Undertaking under Grant Agreement No. 115523 Combating Bacterial Resistance in Europe, the resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007- 2013) and European Federation of Pharmaceutical Industries and Associations companies, in-kind contribution; the French COVID cohort (NCT04262921) is sponsored by INSERM and is funded by the REACTing (REsearch & ACtion emergING infectious diseases) consortium and by a grant of the French Ministry of Health (PHRC n 20-0424); Stiftungsfonds zur Förderung der Bekämpfung der Tuberkulose und anderer Lungenkrankheiten of the City of Vienna, Project Number: APCOV22BGM; Italian Ministry of Health “Fondi Ricerca corrente–L1P6” to IRCCS Ospedale Sacro Cuore–Don Calabria; Australian Department of Health grant (3273191); Gender Equity Strategic Fund at University of Queensland , Artificial Intelligence for Pandemics (A14PAN) at University of Queensland , the Australian Research Council Centre of Excellence for Engineered Quantum Systems (CE170100009), the Prince Charles Hospital Foundation, Australia; Brazil, National Council for Scientific and Technological Development Scholarship number 303953/2018- 7; the Firland Foundation , Shoreline, Washington , USA; a grant from foundation Bevordering Onderzoek Franciscus; the South Eastern Norway Health Authority and the Research Council of Norway; Institute for Clinical Research, National Institutes of Health supported by the Ministry of Health Malaysia; grants from the National Institute for Health Research (NIHR; award CO-CIN-01), the Medical Research Council (grant MC_PC_19059), and by the NIHR Health Protection Research Unit in Emerging and Zoonotic Infections at University of Liverpool in partnership with Public Health England (award 200907), NIHR Health Protection Research Unit in Respiratory Infections at Imperial College London with Public Health England (award 200927), Liverpool Experimental Cancer Medicine Centre (grant C18616/A25153), NIHR Biomedical Research Centre at Imperial College London (award IS-BRC-1215-20013), and NIHR Clinical Research Network providing infrastructure support. M.J.G. received support through the Faculty Small Grant Program from the Vice President for Research of the University of Utah to fund statistical analysis. This project was supported by the University Research Committee and the Study Design and Biostatistics Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, Grant 8UL1TR000105 (formerly UL1RR025764)) at the University of Utah and by Universidad de La Sabana (MED-309-2021) . Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the University Research Committee, Vice President for Research Office, or University of Utah. Funding Information: The investigators acknowledge the support of the COVID clinical management team, All India Institute of Medical Sciences, Rishikesh, India; the dedication and hard work of the Groote Schuur Hospital Covid Intensive Care Unit Team, supported by the Groote Schuur nursing and University of Cape Town registrar bodies coordinated by the Division of Critical Care at the University of Cape Town; the dedication and hard work of the Norwegian SARS-CoV-2 study team; endorsement of the Irish Critical Care- Clinical Trials Group, co-ordination in Ireland by the Irish Critical Care- Clinical Trials Network at University College Dublin; Cambridge National Institute for Health and Care Research Biomedical Research Centre; Liverpool School of Tropical Medicine and the University of Oxford; Imperial National Institute for Health and Care Research Biomedical Research Centre; and preparedness work conducted by the Short Period Incidence Study of Severe Acute Respiratory Infection. This work uses data provided by patients and collected by the National Health Service as part of their care and support #DataSavesLives. The data used for this research were obtained from ISARIC Comprehensive Clinical Characterisation Collaboration. We are extremely grateful to the 2648 frontline National Health Service clinical and research staff and volunteer medical students who collected these data in challenging circumstances as well as the generosity of the patients and their families for their individual contributions in difficult times. COVID-Clinical Information Network data were collated by ISARIC Comprehensive Clinical Characterisation Collaboration Investigators. We also acknowledge the support of Jeremy J. Farrar and Nahoko Shindo. Funding Information: The investigators acknowledge the support of the COVID clinical management team, All India Institute of Medical Sciences, Rishikesh, India; the dedication and hard work of the Groote Schuur Hospital Covid Intensive Care Unit Team, supported by the Groote Schuur nursing and University of Cape Town registrar bodies coordinated by the Division of Critical Care at the University of Cape Town; the dedication and hard work of the Norwegian SARS-CoV-2 study team; endorsement of the Irish Critical Care- Clinical Trials Group, co-ordination in Ireland by the Irish Critical Care- Clinical Trials Network at University College Dublin; Cambridge National Institute for Health and Care Research Biomedical Research Centre; Liverpool School of Tropical Medicine and the University of Oxford; Imperial National Institute for Health and Care Research Biomedical Research Centre; and preparedness work conducted by the Short Period Incidence Study of Severe Acute Respiratory Infection. This work uses data provided by patients and collected by the National Health Service as part of their care and support #DataSavesLives. The data used for this research were obtained from ISARIC Comprehensive Clinical Characterisation Collaboration. We are extremely grateful to the 2648 frontline National Health Service clinical and research staff and volunteer medical students who collected these data in challenging circumstances as well as the generosity of the patients and their families for their individual contributions in difficult times. COVID-Clinical Information Network data were collated by ISARIC Comprehensive Clinical Characterisation Collaboration Investigators. We also acknowledge the support of Jeremy J. Farrar and Nahoko Shindo. This work was made possible by the UK Foreign, Commonwealth and Development Office and Wellcome (215091/Z/18/Z, 222410/Z/21/Z, 225288/Z/22/Z and 220757/Z/20/Z); the Bill & Melinda Gates Foundation (OPP1209135); philanthropic support of the donors to the University of Oxford's COVID-19 Research Response Fund (0009109); CIHR Coronavirus Rapid Research Funding Opportunity OV2170359 and coordination in Canada by Sunnybrook Research Institute; funding by the Health Research Board of Ireland (CTN-2014-12); Rapid European COVID-19 Emergency Response research (H2020 project 101003589) and European Clinical Research Alliance on Infectious Diseases (965313); the Research Council of Norway grant no 312780, and a philanthropic donation from Vivaldi Invest A/S owned by Jon Stephenson von Tetzchner; the Comprehensive Local Research Networks, of which PJMO is an NIHR Senior Investigator (NIHR201385); Innovative Medicines Initiative Joint Undertaking under Grant Agreement No. 115523 Combating Bacterial Resistance in Europe, the resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007- 2013) and European Federation of Pharmaceutical Industries and Associations companies, in-kind contribution; the French COVID cohort (NCT04262921) is sponsored by INSERM and is funded by the REACTing (REsearch & ACtion emergING infectious diseases) consortium and by a grant of the French Ministry of Health (PHRC n 20-0424); Stiftungsfonds zur Förderung der Bekämpfung der Tuberkulose und anderer Lungenkrankheiten of the City of Vienna, Project Number: APCOV22BGM; Italian Ministry of Health “Fondi Ricerca corrente–L1P6” to IRCCS Ospedale Sacro Cuore–Don Calabria; Australian Department of Health grant (3273191); Gender Equity Strategic Fund at University of Queensland, Artificial Intelligence for Pandemics (A14PAN) at University of Queensland, the Australian Research Council Centre of Excellence for Engineered Quantum Systems (CE170100009), the Prince Charles Hospital Foundation, Australia; Brazil, National Council for Scientific and Technological Development Scholarship number 303953/2018- 7; the Firland Foundation, Shoreline, Washington, USA; a grant from foundation Bevordering Onderzoek Franciscus; the South Eastern Norway Health Authority and the Research Council of Norway; Institute for Clinical Research, National Institutes of Health supported by the Ministry of Health Malaysia; grants from the National Institute for Health Research (NIHR; award CO-CIN-01), the Medical Research Council (grant MC_PC_19059), and by the NIHR Health Protection Research Unit in Emerging and Zoonotic Infections at University of Liverpool in partnership with Public Health England (award 200907), NIHR Health Protection Research Unit in Respiratory Infections at Imperial College London with Public Health England (award 200927), Liverpool Experimental Cancer Medicine Centre (grant C18616/A25153), NIHR Biomedical Research Centre at Imperial College London (award IS-BRC-1215-20013), and NIHR Clinical Research Network providing infrastructure support. M.J.G. received support through the Faculty Small Grant Program from the Vice President for Research of the University of Utah to fund statistical analysis. This project was supported by the University Research Committee and the Study Design and Biostatistics Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, Grant 8UL1TR000105 (formerly UL1RR025764)) at the University of Utah and by Universidad de La Sabana (MED-309-2021). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the University Research Committee, Vice President for Research Office, or University of Utah. Ethics approval and informed consent were obtained at each site by the site investigators, according to local regulations, which included a waiver of consent to collect de-identified data at several sites due to the burden on front-line workers and the data protection framework in place. The WHO-ISARIC Clinical Characterization Protocol was approved by the WHO Ethics Committee (RPC571 and RPC572) (Reference [22], pages 2-3). M.J.G. was involved in study conception and design, acquisition of data, analysis and interpretation, drafting and revision of the article, as well as conception and revision of figures. P.T.B. S.-M.C. and L.F.R. were involved in study design, analysis and interpretation of data, revision of the article. D.P.E. was involved in statistical analysis, data cleaning, analysis of data, composition and formatting of figures, and drafting of the manuscript. D.R. was involved in study conception and design, analysis and interpretation of data, and manuscript drafting and revising. L.M. was involved in study design, data acquisition, interpretation of results, revision of data analysis, and proofreading. B.W.C. was involved in study design, data acquisition, and revision of the manuscript. J.F. and P.M.A.A. were involved in study design and interpretation of results. J.F. was involved in concept and design of database and contribution of data. H.D. was involved in concept and design of the study. All authors read and approved the final version of the paper. There are no competing interests to disclose. The data that underpin this analysis are highly detailed clinical data on individuals hospitalized for COVID-19. Due to the sensitive nature of these data and the associated privacy concerns, they are available via a governed data access mechanism following review of a data access committee. Data can be requested via the Infectious Disease Data Observatory COVID-19 Data Sharing Platform (http://www.iddo.org/covid-19). The Data Access Application, Terms of Access, and details of the Data Access Committee are available on the website. Briefly, the requirements for access are a request from a qualified researcher working with a legal entity who has a health and/or research remit; a scientifically valid reason for data access that adheres to appropriate ethical principles. The full terms are at https://www.iddo.org/document/covid-19-data-access-guidelines. A small subset of sites that contributed data to this analysis have not agreed to pooled data sharing as above. In the case of requiring access to these data, please contact the corresponding author in the first instance, who will look to facilitate access. Publisher Copyright: © 2023 The Author(s)
PY - 2023/7/1
Y1 - 2023/7/1
N2 - Background: COVID-19 has been associated with a broad range of thromboembolic, ischemic, and hemorrhagic complications (coagulopathy complications). Most studies have focused on patients with severe disease from high-income countries (HICs). Objectives: The main aims were to compare the frequency of coagulopathy complications in developing countries (low- and middle-income countries [LMICs]) with those in HICs, delineate the frequency across a range of treatment levels, and determine associations with in-hospital mortality. Methods: Adult patients enrolled in an observational, multinational registry, the International Severe Acute Respiratory and Emerging Infections COVID-19 study, between January 1, 2020, and September 15, 2021, met inclusion criteria, including admission to a hospital for laboratory-confirmed, acute COVID-19 and data on complications and survival. The advanced-treatment cohort received care, such as admission to the intensive care unit, mechanical ventilation, or inotropes or vasopressors; the basic-treatment cohort did not receive any of these interventions. Results: The study population included 495,682 patients from 52 countries, with 63% from LMICs and 85% in the basic treatment cohort. The frequency of coagulopathy complications was higher in HICs (0.76%-3.4%) than in LMICs (0.09%-1.22%). Complications were more frequent in the advanced-treatment cohort than in the basic-treatment cohort. Coagulopathy complications were associated with increased in-hospital mortality (odds ratio, 1.58; 95% CI, 1.52-1.64). The increased mortality associated with these complications was higher in LMICs (58.5%) than in HICs (35.4%). After controlling for coagulopathy complications, treatment intensity, and multiple other factors, the mortality was higher among patients in LMICs than among patients in HICs (odds ratio, 1.45; 95% CI, 1.39-1.51). Conclusion: In a large, international registry of patients hospitalized for COVID-19, coagulopathy complications were more frequent in HICs than in LMICs (developing countries). Increased mortality associated with coagulopathy complications was of a greater magnitude among patients in LMICs. Additional research is needed regarding timely diagnosis of and intervention for coagulation derangements associated with COVID-19, particularly for limited-resource settings.
AB - Background: COVID-19 has been associated with a broad range of thromboembolic, ischemic, and hemorrhagic complications (coagulopathy complications). Most studies have focused on patients with severe disease from high-income countries (HICs). Objectives: The main aims were to compare the frequency of coagulopathy complications in developing countries (low- and middle-income countries [LMICs]) with those in HICs, delineate the frequency across a range of treatment levels, and determine associations with in-hospital mortality. Methods: Adult patients enrolled in an observational, multinational registry, the International Severe Acute Respiratory and Emerging Infections COVID-19 study, between January 1, 2020, and September 15, 2021, met inclusion criteria, including admission to a hospital for laboratory-confirmed, acute COVID-19 and data on complications and survival. The advanced-treatment cohort received care, such as admission to the intensive care unit, mechanical ventilation, or inotropes or vasopressors; the basic-treatment cohort did not receive any of these interventions. Results: The study population included 495,682 patients from 52 countries, with 63% from LMICs and 85% in the basic treatment cohort. The frequency of coagulopathy complications was higher in HICs (0.76%-3.4%) than in LMICs (0.09%-1.22%). Complications were more frequent in the advanced-treatment cohort than in the basic-treatment cohort. Coagulopathy complications were associated with increased in-hospital mortality (odds ratio, 1.58; 95% CI, 1.52-1.64). The increased mortality associated with these complications was higher in LMICs (58.5%) than in HICs (35.4%). After controlling for coagulopathy complications, treatment intensity, and multiple other factors, the mortality was higher among patients in LMICs than among patients in HICs (odds ratio, 1.45; 95% CI, 1.39-1.51). Conclusion: In a large, international registry of patients hospitalized for COVID-19, coagulopathy complications were more frequent in HICs than in LMICs (developing countries). Increased mortality associated with coagulopathy complications was of a greater magnitude among patients in LMICs. Additional research is needed regarding timely diagnosis of and intervention for coagulation derangements associated with COVID-19, particularly for limited-resource settings.
KW - COVID-19
KW - SARS-CoV-2
KW - developing countries
KW - disseminated intravascular coagulation
KW - hemorrhage
KW - ischemic stroke
KW - thromboembolism
KW - thrombosis
UR - http://www.scopus.com/inward/record.url?scp=85167416327&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.rpth.2023.102142
DO - https://doi.org/10.1016/j.rpth.2023.102142
M3 - Article
C2 - 37601011
SN - 2475-0379
VL - 7
JO - Research and practice in thrombosis and haemostasis
JF - Research and practice in thrombosis and haemostasis
IS - 5
M1 - 102142
ER -