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Vol 11, No 3 (2018)
ORIGINAL PAPERS
Published online: 2019-01-15
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Analiza poważnych niepożądanych zdarzeń i poważnych niepożądanych reakcji poprzetoczeniowych w Polsce w latach 2011–2014 Część II. Reakcje poprzetoczeniowe niezwiązane z obcogrupowym przetoczeniem składników krwi

Ryszard Pogłód, Aleksandra Rosiek, Bogumiła Michalewska, Joanna Kubis, Piotr Grabarczyk, Małgorzata Uhrynowska, Elżbieta Lachert, Magdalena Łętowska
Journal of Transfusion Medicine 2018;11(3):75-90.

open access

Vol 11, No 3 (2018)
ORIGINAL PAPERS
Published online: 2019-01-15

Abstract

Background. Analysis of serious adverse events (SAE) and serious adverse reactions (SAR) related to transfusion of blood components and also of the reporting system are essential for effective haemovigilance. This report is a sequel of Part I Serious adverse events and serious adverse transfusion reactions related to transfusion of an incompatible blood component /Analysis of serious adverse events and serious adverse transfusion reactions in Poland between 2011 and 2014 (published in Journal of Transfusion Medicine, 2018, v.11, no 1). The report is based on the analysis of SAE and SAR reported to the Institute of Hematology and Transfusion Medicine (IHTM) by Polish blood transfusion centers in the period 2011–2014. The primary aim of Part II was to analyze the reported SAR cases not related to transfusion of incompatible blood components including incidence rate, type of blood component, consequences (deaths) as well as reliable categorization and adherence to medical indications for transfusion. The secondary aim was the analysis of all SAR cases reported by our country to the European Commission (EC). Material and methods. The basic material was provided by blood transfusion center in form of reports to the Institute of Hematology and Transfusion Medicine (IHTM) of serious adverse events and reactions in 2011–2014. The reports forwarded to IHTM in this period were subjected to analysis by the IHTM Work Group for Analysis of Transfusion-related Adverse Events and Reactions in Poland (IHTM Work Group). Additional material for analysis were annual reports of SAR cases in Poland forwarded to the EC in the period 2011–2014 as well as 2015–2016. The decision to extend the reporting period resulted from the marked change in the number of SAR cases reported to the EC observed in the period 2013–2014 and also from the desire to present fully reliable data. Results. A total of 72 SAR and SAE cases were forwarded to IHTM in the 2013-2014 period; 21 of them were cases of SAR unrelated to transfusion of incompatible blood components. These included: transfusion-related acute lung injury — TRALI (6 cases), transfusion-related circulatory overload TACO (5 cases), anaphylactic reaction (3 cases), febrile non-haemolytic transfusion reaction — FNHTR (2 cases), sepsis (2 cases), transfusion associated dyspnea —TAD (1 case) as well as other serious cardiovascular episodes that occurred during or immediately following transfusion (2 cases). Most frequent were reports of SAR following transfusions of red blood cells (RBC — 10 cases), FFP (6 cases), least frequent were SAR reports following transfusions of platelet concentrates PC (1 case). Four (4) cases of SAR were reported after transfusion of more than one blood component. Allergic and anaphylactic reactions occurred after FFP transfusion or transfusions of FFP and red blood cells only. TACO occurrence was related to transfusion of red blood cells only or transfusion of red blood cells and FFP. Transmission of bacterial infection and sepsis (1 case) occurred after transfusion of PC. In 15 out of 21 cases the primary SAR categorization as forwarded in reports was considered proper. In some cases the relation between SAR and transfusion was not easy to determine especially if the patient’s overall condition during transfusion was serious. In 6 cases of reported death no direct relation to transfusion was determined. As regards indications for transfusion — in 2/21 cases the indications were questionable. Additional analysis of Polish data reported to EU in the four-year period (2011–2014) revealed a marked decrease in the number of annually reported SAR cases; from 402 in 2011 to 71 in 2012 and 21 in 2016. Realignment of the number of reported cases resulted from improvement of reporting and, above all, stricter adherence to the definition of SAR. A 4-year reference period was adopted, however, it was extended to cover the years 2013–2016 because then the annual number of reported SAR cases became relatively stable to include 18 to 36 cases per year. In this period a total of 105 SAR cases was reported. The SAR cases most frequently reported to EC were allergic and anaphylactic reactions (31 cases), TRALI (21 cases), haemolytic reactions as result of transfusion of incompatible blood components (19 cases) and TACO (16 cases). The initial categorization of SAR was corrected by the IHTM Work Group in 6 cases. In one case the reported SAR resulted in death as consequence of transfusion of incompatible red blood cells. The ratio of the number of SAR cases per 100,000 units of issued blood components ranged from 1.11 to 1.58, with the relatively highest variation for PC (0.93–4.41). Conclusions. Among the SAR cases unrelated to transfusion of incompatible blood components that were forwarded to IHTM and analized by the IHTM Work Group the most frequent were TRALI, TACO and anaphylactic reactions. On the other hand, allergic and anaphylactic reactions, haemolytic reactions related to transfusion of incompatible blood components, and TRALI were dominant in the overall annual reports from the territory of Poland to EC; TACO was reported less frequently. Both analyses reveal a marked contribution and significance of SAR due to cardiovascular and respiratory reactions. What is positive is the low number of bacterial infections transmitted with transfusion of blood components as well as compliance with the indications for transfusion of blood components. What caused problems is the initial categorization of SAR cases and determination of the relationship between SAR and transfusion, especially in fatal cases. The analyzed period witnessed a marked improvement in SAR reporting from our country to the EC which resulted in realignment of data and stabilization of the annual number of SARE.

Abstract

Background. Analysis of serious adverse events (SAE) and serious adverse reactions (SAR) related to transfusion of blood components and also of the reporting system are essential for effective haemovigilance. This report is a sequel of Part I Serious adverse events and serious adverse transfusion reactions related to transfusion of an incompatible blood component /Analysis of serious adverse events and serious adverse transfusion reactions in Poland between 2011 and 2014 (published in Journal of Transfusion Medicine, 2018, v.11, no 1). The report is based on the analysis of SAE and SAR reported to the Institute of Hematology and Transfusion Medicine (IHTM) by Polish blood transfusion centers in the period 2011–2014. The primary aim of Part II was to analyze the reported SAR cases not related to transfusion of incompatible blood components including incidence rate, type of blood component, consequences (deaths) as well as reliable categorization and adherence to medical indications for transfusion. The secondary aim was the analysis of all SAR cases reported by our country to the European Commission (EC). Material and methods. The basic material was provided by blood transfusion center in form of reports to the Institute of Hematology and Transfusion Medicine (IHTM) of serious adverse events and reactions in 2011–2014. The reports forwarded to IHTM in this period were subjected to analysis by the IHTM Work Group for Analysis of Transfusion-related Adverse Events and Reactions in Poland (IHTM Work Group). Additional material for analysis were annual reports of SAR cases in Poland forwarded to the EC in the period 2011–2014 as well as 2015–2016. The decision to extend the reporting period resulted from the marked change in the number of SAR cases reported to the EC observed in the period 2013–2014 and also from the desire to present fully reliable data. Results. A total of 72 SAR and SAE cases were forwarded to IHTM in the 2013-2014 period; 21 of them were cases of SAR unrelated to transfusion of incompatible blood components. These included: transfusion-related acute lung injury — TRALI (6 cases), transfusion-related circulatory overload TACO (5 cases), anaphylactic reaction (3 cases), febrile non-haemolytic transfusion reaction — FNHTR (2 cases), sepsis (2 cases), transfusion associated dyspnea —TAD (1 case) as well as other serious cardiovascular episodes that occurred during or immediately following transfusion (2 cases). Most frequent were reports of SAR following transfusions of red blood cells (RBC — 10 cases), FFP (6 cases), least frequent were SAR reports following transfusions of platelet concentrates PC (1 case). Four (4) cases of SAR were reported after transfusion of more than one blood component. Allergic and anaphylactic reactions occurred after FFP transfusion or transfusions of FFP and red blood cells only. TACO occurrence was related to transfusion of red blood cells only or transfusion of red blood cells and FFP. Transmission of bacterial infection and sepsis (1 case) occurred after transfusion of PC. In 15 out of 21 cases the primary SAR categorization as forwarded in reports was considered proper. In some cases the relation between SAR and transfusion was not easy to determine especially if the patient’s overall condition during transfusion was serious. In 6 cases of reported death no direct relation to transfusion was determined. As regards indications for transfusion — in 2/21 cases the indications were questionable. Additional analysis of Polish data reported to EU in the four-year period (2011–2014) revealed a marked decrease in the number of annually reported SAR cases; from 402 in 2011 to 71 in 2012 and 21 in 2016. Realignment of the number of reported cases resulted from improvement of reporting and, above all, stricter adherence to the definition of SAR. A 4-year reference period was adopted, however, it was extended to cover the years 2013–2016 because then the annual number of reported SAR cases became relatively stable to include 18 to 36 cases per year. In this period a total of 105 SAR cases was reported. The SAR cases most frequently reported to EC were allergic and anaphylactic reactions (31 cases), TRALI (21 cases), haemolytic reactions as result of transfusion of incompatible blood components (19 cases) and TACO (16 cases). The initial categorization of SAR was corrected by the IHTM Work Group in 6 cases. In one case the reported SAR resulted in death as consequence of transfusion of incompatible red blood cells. The ratio of the number of SAR cases per 100,000 units of issued blood components ranged from 1.11 to 1.58, with the relatively highest variation for PC (0.93–4.41). Conclusions. Among the SAR cases unrelated to transfusion of incompatible blood components that were forwarded to IHTM and analized by the IHTM Work Group the most frequent were TRALI, TACO and anaphylactic reactions. On the other hand, allergic and anaphylactic reactions, haemolytic reactions related to transfusion of incompatible blood components, and TRALI were dominant in the overall annual reports from the territory of Poland to EC; TACO was reported less frequently. Both analyses reveal a marked contribution and significance of SAR due to cardiovascular and respiratory reactions. What is positive is the low number of bacterial infections transmitted with transfusion of blood components as well as compliance with the indications for transfusion of blood components. What caused problems is the initial categorization of SAR cases and determination of the relationship between SAR and transfusion, especially in fatal cases. The analyzed period witnessed a marked improvement in SAR reporting from our country to the EC which resulted in realignment of data and stabilization of the annual number of SARE.
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Keywords

serious adverse post transfusion reaction; serious adverse event related to transfusion; systems for registration of events and reactions related to transfusion; haemovigilance

About this article
Title

Analiza poważnych niepożądanych zdarzeń i poważnych niepożądanych reakcji poprzetoczeniowych w Polsce w latach 2011–2014 Część II. Reakcje poprzetoczeniowe niezwiązane z obcogrupowym przetoczeniem składników krwi

Journal

Journal of Transfusion Medicine

Issue

Vol 11, No 3 (2018)

Pages

75-90

Published online

2019-01-15

Bibliographic record

Journal of Transfusion Medicine 2018;11(3):75-90.

Keywords

serious adverse post transfusion reaction
serious adverse event related to transfusion
systems for registration of events and reactions related to transfusion
haemovigilance

Authors

Ryszard Pogłód
Aleksandra Rosiek
Bogumiła Michalewska
Joanna Kubis
Piotr Grabarczyk
Małgorzata Uhrynowska
Elżbieta Lachert
Magdalena Łętowska

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