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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Published in | Transfusion (Philadelphia, Pa.) Vol. 61; no. 1; pp. 78 - 93 |
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Main Authors | , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Hoboken, USA
John Wiley & Sons, Inc
01.01.2021
Wiley Subscription Services, Inc |
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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. |
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AbstractList | 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.BACKGROUNDConvalescent 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.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.STUDY DESIGN AND METHODSRetrospective 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.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.RESULTSFifty-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.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.CONCLUSIONOur 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. 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. BackgroundConvalescent 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 MethodsRetrospective 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.ResultsFifty‐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.ConclusionOur 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. 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. 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. 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. 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. |
Author | Nguyen, Freddy T. Krammer, Florian Lally, Kimberly Aberg, Judith A. Lenskaya, Volha Liu, Sean T. H. Lam, Hansen Rudon, Louella Shaz, Beth H. Galdon, Patricia Baine, Ian Strauss, Donna Bouvier, Nicole M. Arinsburg, Suzanne A. Akker, Tayler Rodriguez, Denise Jhang, Jeffrey S. |
Author_xml | – sequence: 1 givenname: Freddy T. surname: Nguyen fullname: Nguyen, Freddy T. organization: Massachusetts Institute of Technology – sequence: 2 givenname: Tayler surname: Akker fullname: Akker, Tayler organization: Icahn School of Medicine at Mount Sinai West – sequence: 3 givenname: Kimberly surname: Lally fullname: Lally, Kimberly organization: Icahn School of Medicine at Mount Sinai – sequence: 4 givenname: Hansen surname: Lam fullname: Lam, Hansen organization: Icahn School of Medicine at Mount Sinai – sequence: 5 givenname: Volha surname: Lenskaya fullname: Lenskaya, Volha organization: Icahn School of Medicine at Mount Sinai – sequence: 6 givenname: Sean T. H. surname: Liu fullname: Liu, Sean T. H. organization: Icahn School of Medicine at Mount Sinai – sequence: 7 givenname: Nicole M. surname: Bouvier fullname: Bouvier, Nicole M. organization: Icahn School of Medicine at Mount Sinai – sequence: 8 givenname: Judith A. surname: Aberg fullname: Aberg, Judith A. organization: Icahn School of Medicine at Mount Sinai – sequence: 9 givenname: Denise surname: Rodriguez fullname: Rodriguez, Denise organization: Tisch Cancer Institute – sequence: 10 givenname: Florian surname: Krammer fullname: Krammer, Florian organization: Icahn School of Medicine at Mount Sinai – sequence: 11 givenname: Donna surname: Strauss fullname: Strauss, Donna organization: New York Blood Center Enterprises – sequence: 12 givenname: Beth H. orcidid: 0000-0002-2270-4821 surname: Shaz fullname: Shaz, Beth H. organization: New York Blood Center Enterprises – sequence: 13 givenname: Louella surname: Rudon fullname: Rudon, Louella organization: Icahn School of Medicine at Mount Sinai – sequence: 14 givenname: Patricia surname: Galdon fullname: Galdon, Patricia organization: Icahn School of Medicine at Mount Sinai – sequence: 15 givenname: Jeffrey S. surname: Jhang fullname: Jhang, Jeffrey S. organization: Icahn School of Medicine at Mount Sinai – sequence: 16 givenname: Suzanne A. orcidid: 0000-0002-0739-9152 surname: Arinsburg fullname: Arinsburg, Suzanne A. organization: Icahn School of Medicine at Mount Sinai – sequence: 17 givenname: Ian orcidid: 0000-0002-0419-0054 surname: Baine fullname: Baine, Ian organization: Icahn School of Medicine at Mount Sinai |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33125158$$D View this record in MEDLINE/PubMed |
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Convalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has shown preliminary signs of effectiveness... Convalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has shown preliminary signs of effectiveness in moderate... BackgroundConvalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) has shown preliminary signs of effectiveness... |
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SubjectTerms | 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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