Transfusion reactions associated with COVID‐19 convalescent plasma therapy for SARS‐CoV‐2

Background Convalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has shown preliminary signs of effectiveness in moderate to severely ill patients in reducing mortality. While studies have demonstrated a low risk of serious adverse events, the compreh...

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Veröffentlicht in:Transfusion (Philadelphia, Pa.) Pa.), 2021-01, Vol.61 (1), p.78-93
Hauptverfasser: Nguyen, Freddy T., Akker, Tayler, Lally, Kimberly, Lam, Hansen, Lenskaya, Volha, Liu, Sean T. H., Bouvier, Nicole M., Aberg, Judith A., Rodriguez, Denise, Krammer, Florian, Strauss, Donna, Shaz, Beth H., Rudon, Louella, Galdon, Patricia, Jhang, Jeffrey S., Arinsburg, Suzanne A., Baine, Ian
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container_end_page 93
container_issue 1
container_start_page 78
container_title Transfusion (Philadelphia, Pa.)
container_volume 61
creator Nguyen, Freddy T.
Akker, Tayler
Lally, Kimberly
Lam, Hansen
Lenskaya, Volha
Liu, Sean T. H.
Bouvier, Nicole M.
Aberg, Judith A.
Rodriguez, Denise
Krammer, Florian
Strauss, Donna
Shaz, Beth H.
Rudon, Louella
Galdon, Patricia
Jhang, Jeffrey S.
Arinsburg, Suzanne A.
Baine, Ian
description Background Convalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has shown preliminary signs of effectiveness in moderate to severely ill patients in reducing mortality. While studies have demonstrated a low risk of serious adverse events, the comprehensive incidence and nature of the spectrum of transfusion reactions to CP is unknown. We retrospectively examined 427 adult inpatient CP transfusions to determine incidence and types of reactions, as well as clinical parameters and risk factors associated with transfusion reactions. Study Design and Methods Retrospective analysis was performed for 427 transfusions to 215 adult patients with coronavirus 2019 (COVID‐19) within the Mount Sinai Health System, through the US Food and Drug Administration emergency investigational new drug and the Mayo Clinic Expanded Access Protocol to Convalescent Plasma approval pathways. Transfusions were blindly evaluated by two reviewers and adjudicated by a third reviewer in discordant cases. Patient demographics and clinical and laboratory parameters were compared and analyzed. Results Fifty‐five reactions from 427 transfusions were identified (12.9% incidence), and 13 were attributed to transfusion (3.1% incidence). Reactions were classified as underlying COVID‐19 (76%), febrile nonhemolytic (10.9%), transfusion‐associated circulatory overload (9.1%), and allergic (1.8%) and hypotensive (1.8%) reactions. Statistical analysis identified increased transfusion reaction risk for ABO blood group B or Sequential Organ Failure Assessment scores of 12 to 13, and decreased risk within the age group of 80 to 89 years. Conclusion Our findings support the use of CP as a safe, therapeutic option from a transfusion reaction perspective, in the setting of COVID‐19. Further studies are needed to confirm the clinical significance of ABO group B, age, and predisposing disease severity in the incidence of transfusion reaction events.
doi_str_mv 10.1111/trf.16177
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H. ; Bouvier, Nicole M. ; Aberg, Judith A. ; Rodriguez, Denise ; Krammer, Florian ; Strauss, Donna ; Shaz, Beth H. ; Rudon, Louella ; Galdon, Patricia ; Jhang, Jeffrey S. ; Arinsburg, Suzanne A. ; Baine, Ian</creator><creatorcontrib>Nguyen, Freddy T. ; Akker, Tayler ; Lally, Kimberly ; Lam, Hansen ; Lenskaya, Volha ; Liu, Sean T. H. ; Bouvier, Nicole M. ; Aberg, Judith A. ; Rodriguez, Denise ; Krammer, Florian ; Strauss, Donna ; Shaz, Beth H. ; Rudon, Louella ; Galdon, Patricia ; Jhang, Jeffrey S. ; Arinsburg, Suzanne A. ; Baine, Ian ; Mount Sinai Health System Convalescent Plasma Team ; The Mount Sinai Health System Convalescent Plasma Team</creatorcontrib><description>Background Convalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has shown preliminary signs of effectiveness in moderate to severely ill patients in reducing mortality. While studies have demonstrated a low risk of serious adverse events, the comprehensive incidence and nature of the spectrum of transfusion reactions to CP is unknown. We retrospectively examined 427 adult inpatient CP transfusions to determine incidence and types of reactions, as well as clinical parameters and risk factors associated with transfusion reactions. Study Design and Methods Retrospective analysis was performed for 427 transfusions to 215 adult patients with coronavirus 2019 (COVID‐19) within the Mount Sinai Health System, through the US Food and Drug Administration emergency investigational new drug and the Mayo Clinic Expanded Access Protocol to Convalescent Plasma approval pathways. Transfusions were blindly evaluated by two reviewers and adjudicated by a third reviewer in discordant cases. Patient demographics and clinical and laboratory parameters were compared and analyzed. Results Fifty‐five reactions from 427 transfusions were identified (12.9% incidence), and 13 were attributed to transfusion (3.1% incidence). Reactions were classified as underlying COVID‐19 (76%), febrile nonhemolytic (10.9%), transfusion‐associated circulatory overload (9.1%), and allergic (1.8%) and hypotensive (1.8%) reactions. Statistical analysis identified increased transfusion reaction risk for ABO blood group B or Sequential Organ Failure Assessment scores of 12 to 13, and decreased risk within the age group of 80 to 89 years. Conclusion Our findings support the use of CP as a safe, therapeutic option from a transfusion reaction perspective, in the setting of COVID‐19. Further studies are needed to confirm the clinical significance of ABO group B, age, and predisposing disease severity in the incidence of transfusion reaction events.</description><identifier>ISSN: 0041-1132</identifier><identifier>EISSN: 1537-2995</identifier><identifier>DOI: 10.1111/trf.16177</identifier><identifier>PMID: 33125158</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley &amp; Sons, Inc</publisher><subject>ABO system ; Adverse events ; Aged ; Blood group B ; Blood groups ; Blood Transfusion ; Coronaviridae ; Coronaviruses ; COVID-19 ; COVID-19 - therapy ; Demographics ; Demography ; Female ; FFP transfusion ; Humans ; Immunization, Passive - methods ; immunology (other than RBC serology) ; Male ; Middle Aged ; Parameters ; Patients ; Retrospective Studies ; Risk analysis ; Risk factors ; SARS-CoV-2 - pathogenicity ; Severe acute respiratory syndrome ; Severe acute respiratory syndrome coronavirus 2 ; Statistical analysis ; Transfusion ; transfusion practices (adult) ; Transfusion Reaction ; Viral diseases</subject><ispartof>Transfusion (Philadelphia, Pa.), 2021-01, Vol.61 (1), p.78-93</ispartof><rights>2020 AABB</rights><rights>2020 AABB.</rights><rights>2021 AABB</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3537-ca81a5c0843f2761250d2eaff8236330f7fafd36769a05fc364c2b71c89f3cb83</citedby><cites>FETCH-LOGICAL-c3537-ca81a5c0843f2761250d2eaff8236330f7fafd36769a05fc364c2b71c89f3cb83</cites><orcidid>0000-0002-2270-4821 ; 0000-0002-0419-0054 ; 0000-0002-0739-9152</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Ftrf.16177$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Ftrf.16177$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33125158$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nguyen, Freddy T.</creatorcontrib><creatorcontrib>Akker, Tayler</creatorcontrib><creatorcontrib>Lally, Kimberly</creatorcontrib><creatorcontrib>Lam, Hansen</creatorcontrib><creatorcontrib>Lenskaya, Volha</creatorcontrib><creatorcontrib>Liu, Sean T. H.</creatorcontrib><creatorcontrib>Bouvier, Nicole M.</creatorcontrib><creatorcontrib>Aberg, Judith A.</creatorcontrib><creatorcontrib>Rodriguez, Denise</creatorcontrib><creatorcontrib>Krammer, Florian</creatorcontrib><creatorcontrib>Strauss, Donna</creatorcontrib><creatorcontrib>Shaz, Beth H.</creatorcontrib><creatorcontrib>Rudon, Louella</creatorcontrib><creatorcontrib>Galdon, Patricia</creatorcontrib><creatorcontrib>Jhang, Jeffrey S.</creatorcontrib><creatorcontrib>Arinsburg, Suzanne A.</creatorcontrib><creatorcontrib>Baine, Ian</creatorcontrib><creatorcontrib>Mount Sinai Health System Convalescent Plasma Team</creatorcontrib><creatorcontrib>The Mount Sinai Health System Convalescent Plasma Team</creatorcontrib><title>Transfusion reactions associated with COVID‐19 convalescent plasma therapy for SARS‐CoV‐2</title><title>Transfusion (Philadelphia, Pa.)</title><addtitle>Transfusion</addtitle><description>Background Convalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has shown preliminary signs of effectiveness in moderate to severely ill patients in reducing mortality. While studies have demonstrated a low risk of serious adverse events, the comprehensive incidence and nature of the spectrum of transfusion reactions to CP is unknown. We retrospectively examined 427 adult inpatient CP transfusions to determine incidence and types of reactions, as well as clinical parameters and risk factors associated with transfusion reactions. Study Design and Methods Retrospective analysis was performed for 427 transfusions to 215 adult patients with coronavirus 2019 (COVID‐19) within the Mount Sinai Health System, through the US Food and Drug Administration emergency investigational new drug and the Mayo Clinic Expanded Access Protocol to Convalescent Plasma approval pathways. Transfusions were blindly evaluated by two reviewers and adjudicated by a third reviewer in discordant cases. Patient demographics and clinical and laboratory parameters were compared and analyzed. Results Fifty‐five reactions from 427 transfusions were identified (12.9% incidence), and 13 were attributed to transfusion (3.1% incidence). Reactions were classified as underlying COVID‐19 (76%), febrile nonhemolytic (10.9%), transfusion‐associated circulatory overload (9.1%), and allergic (1.8%) and hypotensive (1.8%) reactions. Statistical analysis identified increased transfusion reaction risk for ABO blood group B or Sequential Organ Failure Assessment scores of 12 to 13, and decreased risk within the age group of 80 to 89 years. Conclusion Our findings support the use of CP as a safe, therapeutic option from a transfusion reaction perspective, in the setting of COVID‐19. Further studies are needed to confirm the clinical significance of ABO group B, age, and predisposing disease severity in the incidence of transfusion reaction events.</description><subject>ABO system</subject><subject>Adverse events</subject><subject>Aged</subject><subject>Blood group B</subject><subject>Blood groups</subject><subject>Blood Transfusion</subject><subject>Coronaviridae</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - therapy</subject><subject>Demographics</subject><subject>Demography</subject><subject>Female</subject><subject>FFP transfusion</subject><subject>Humans</subject><subject>Immunization, Passive - methods</subject><subject>immunology (other than RBC serology)</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Parameters</subject><subject>Patients</subject><subject>Retrospective Studies</subject><subject>Risk analysis</subject><subject>Risk factors</subject><subject>SARS-CoV-2 - pathogenicity</subject><subject>Severe acute respiratory syndrome</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Statistical analysis</subject><subject>Transfusion</subject><subject>transfusion practices (adult)</subject><subject>Transfusion Reaction</subject><subject>Viral diseases</subject><issn>0041-1132</issn><issn>1537-2995</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10MFKwzAcBvAgipvTgy8gAS96mMs_aZP2OKrTgTDQ6TVkWYKVrplJ69jNR_AZfRIzpx4Ec0hy-PHx8SF0DOQC4hk03l4AByF2UBdSJvo0z9Nd1CUkgT4Aox10EMIzIYTmBPZRhzGgKaRZF8mpV3WwbShdjb1RuomfgFUITpeqMXO8KpsnXEwex5cfb--QY-3qV1WZoE3d4GWlwkLh5sl4tVxj6zy-H97dR1m4x3jTQ7RnVRXM0ffbQw-jq2lx07-dXI-L4W1fs01hrTJQqSZZwiwVPLYjc2qUtRllnDFihVV2zrjguSKp1Ywnms4E6Cy3TM8y1kNn29yldy-tCY1clLFiVanauDZImqQ8AZ7nLNLTP_TZtb6O7aISnAMjQkR1vlXauxC8sXLpy4XyawlEblaXcXX5tXq0J9-J7Wxh5r_yZ-YIBluwKiuz_j9JTu9G28hPaNmNIA</recordid><startdate>202101</startdate><enddate>202101</enddate><creator>Nguyen, Freddy T.</creator><creator>Akker, Tayler</creator><creator>Lally, Kimberly</creator><creator>Lam, Hansen</creator><creator>Lenskaya, Volha</creator><creator>Liu, Sean T. 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H. ; Bouvier, Nicole M. ; Aberg, Judith A. ; Rodriguez, Denise ; Krammer, Florian ; Strauss, Donna ; Shaz, Beth H. ; Rudon, Louella ; Galdon, Patricia ; Jhang, Jeffrey S. ; Arinsburg, Suzanne A. ; Baine, Ian</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3537-ca81a5c0843f2761250d2eaff8236330f7fafd36769a05fc364c2b71c89f3cb83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>ABO system</topic><topic>Adverse events</topic><topic>Aged</topic><topic>Blood group B</topic><topic>Blood groups</topic><topic>Blood Transfusion</topic><topic>Coronaviridae</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>COVID-19 - therapy</topic><topic>Demographics</topic><topic>Demography</topic><topic>Female</topic><topic>FFP transfusion</topic><topic>Humans</topic><topic>Immunization, Passive - methods</topic><topic>immunology (other than RBC serology)</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Parameters</topic><topic>Patients</topic><topic>Retrospective Studies</topic><topic>Risk analysis</topic><topic>Risk factors</topic><topic>SARS-CoV-2 - pathogenicity</topic><topic>Severe acute respiratory syndrome</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Statistical analysis</topic><topic>Transfusion</topic><topic>transfusion practices (adult)</topic><topic>Transfusion Reaction</topic><topic>Viral diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nguyen, Freddy T.</creatorcontrib><creatorcontrib>Akker, Tayler</creatorcontrib><creatorcontrib>Lally, Kimberly</creatorcontrib><creatorcontrib>Lam, Hansen</creatorcontrib><creatorcontrib>Lenskaya, Volha</creatorcontrib><creatorcontrib>Liu, Sean T. H.</creatorcontrib><creatorcontrib>Bouvier, Nicole M.</creatorcontrib><creatorcontrib>Aberg, Judith A.</creatorcontrib><creatorcontrib>Rodriguez, Denise</creatorcontrib><creatorcontrib>Krammer, Florian</creatorcontrib><creatorcontrib>Strauss, Donna</creatorcontrib><creatorcontrib>Shaz, Beth H.</creatorcontrib><creatorcontrib>Rudon, Louella</creatorcontrib><creatorcontrib>Galdon, Patricia</creatorcontrib><creatorcontrib>Jhang, Jeffrey S.</creatorcontrib><creatorcontrib>Arinsburg, Suzanne A.</creatorcontrib><creatorcontrib>Baine, Ian</creatorcontrib><creatorcontrib>Mount Sinai Health System Convalescent Plasma Team</creatorcontrib><creatorcontrib>The Mount Sinai Health System Convalescent Plasma Team</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Transfusion (Philadelphia, Pa.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nguyen, Freddy T.</au><au>Akker, Tayler</au><au>Lally, Kimberly</au><au>Lam, Hansen</au><au>Lenskaya, Volha</au><au>Liu, Sean T. H.</au><au>Bouvier, Nicole M.</au><au>Aberg, Judith A.</au><au>Rodriguez, Denise</au><au>Krammer, Florian</au><au>Strauss, Donna</au><au>Shaz, Beth H.</au><au>Rudon, Louella</au><au>Galdon, Patricia</au><au>Jhang, Jeffrey S.</au><au>Arinsburg, Suzanne A.</au><au>Baine, Ian</au><aucorp>Mount Sinai Health System Convalescent Plasma Team</aucorp><aucorp>The Mount Sinai Health System Convalescent Plasma Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transfusion reactions associated with COVID‐19 convalescent plasma therapy for SARS‐CoV‐2</atitle><jtitle>Transfusion (Philadelphia, Pa.)</jtitle><addtitle>Transfusion</addtitle><date>2021-01</date><risdate>2021</risdate><volume>61</volume><issue>1</issue><spage>78</spage><epage>93</epage><pages>78-93</pages><issn>0041-1132</issn><eissn>1537-2995</eissn><abstract>Background Convalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has shown preliminary signs of effectiveness in moderate to severely ill patients in reducing mortality. While studies have demonstrated a low risk of serious adverse events, the comprehensive incidence and nature of the spectrum of transfusion reactions to CP is unknown. We retrospectively examined 427 adult inpatient CP transfusions to determine incidence and types of reactions, as well as clinical parameters and risk factors associated with transfusion reactions. Study Design and Methods Retrospective analysis was performed for 427 transfusions to 215 adult patients with coronavirus 2019 (COVID‐19) within the Mount Sinai Health System, through the US Food and Drug Administration emergency investigational new drug and the Mayo Clinic Expanded Access Protocol to Convalescent Plasma approval pathways. Transfusions were blindly evaluated by two reviewers and adjudicated by a third reviewer in discordant cases. Patient demographics and clinical and laboratory parameters were compared and analyzed. Results Fifty‐five reactions from 427 transfusions were identified (12.9% incidence), and 13 were attributed to transfusion (3.1% incidence). Reactions were classified as underlying COVID‐19 (76%), febrile nonhemolytic (10.9%), transfusion‐associated circulatory overload (9.1%), and allergic (1.8%) and hypotensive (1.8%) reactions. Statistical analysis identified increased transfusion reaction risk for ABO blood group B or Sequential Organ Failure Assessment scores of 12 to 13, and decreased risk within the age group of 80 to 89 years. Conclusion Our findings support the use of CP as a safe, therapeutic option from a transfusion reaction perspective, in the setting of COVID‐19. Further studies are needed to confirm the clinical significance of ABO group B, age, and predisposing disease severity in the incidence of transfusion reaction events.</abstract><cop>Hoboken, USA</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>33125158</pmid><doi>10.1111/trf.16177</doi><tpages>16</tpages><orcidid>https://orcid.org/0000-0002-2270-4821</orcidid><orcidid>https://orcid.org/0000-0002-0419-0054</orcidid><orcidid>https://orcid.org/0000-0002-0739-9152</orcidid></addata></record>
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subjects ABO system
Adverse events
Aged
Blood group B
Blood groups
Blood Transfusion
Coronaviridae
Coronaviruses
COVID-19
COVID-19 - therapy
Demographics
Demography
Female
FFP transfusion
Humans
Immunization, Passive - methods
immunology (other than RBC serology)
Male
Middle Aged
Parameters
Patients
Retrospective Studies
Risk analysis
Risk factors
SARS-CoV-2 - pathogenicity
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Statistical analysis
Transfusion
transfusion practices (adult)
Transfusion Reaction
Viral diseases
title Transfusion reactions associated with COVID‐19 convalescent plasma therapy for SARS‐CoV‐2
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