Figure 1: ATEs related to transfused products per year (N=1,040). 8

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2 Table of Contents Table of Contents Acknowledgement 4 Executive Summary 5 Methodology 7 Blood Products and ATEs 8 Table 1A: Adverse Transfusion Events (ATEs),N (%) by type of product and year. 8 Figure 1: ATEs related to transfused products per year (N=1,040). 8 Table 1B: Number and percent of ATEs by reaction type for blood components and plasma derivatives, N (%). 9 Transfusion Activity Table 2: Transfusion activity (calculated from blood components transfused) of Ontario Hospitals. 10 Figure 2: Number of units of blood components transfused by year. 10 Blood and ATEs 11 Figure 3: Blood that were associated with ATEs (N=733). 11 Table 3: Number and percent N (%) ATEs associated with each blood component per year (N=733). 11 Figure 4: Relationship of ATEs to blood components (N=733). 11 Table 4: Relationship of ATEs from by blood component type. 12 Figure 5: Severity of ATEs for all blood components (N=733). 12 Table 5A: Severity of ATEs per year for all blood component types, N (%). 13 Table 5B: Severity of ATEs by blood component type, N (%). 13 Figure 6: Outcome of ATEs for all blood components (N=733). 13 Table 6A: Outcome of ATEs per year for all blood component types. 14 Table 6B: Outcome of ATEs by each blood component type. 14 Table 7A: Type of ATE summarized by individual blood component type (N, %) (N=733). 15 Table 7B: Relationship of the ATE by reaction type for all blood component types (N, %) (N=733). 16 Figure 8: Number of ATEs per year by reaction type for all blood component types (N=733). 17 Risk Calculations 18 Table 8A: Number of blood components transfused at the sentinel sites. 18 i P a g e

3 Table of Contents Table 8B: Number of ATEs by type of blood component and the risk estimate. 18 Table 8C: Risk of an ATE by blood component and type of reaction. 19 Plasma Derivatives 20 Table 9: Number and percent (N,%) of ATEs, by year, related to plasma derivatives (N=297). 20 Figure 9: ATEs related to plasma derivatives (N=297). 20 Figure 10 (A,B,C): Relationship, Severity and Outcomes of ATEs related to IVIG (N=267). 21 Table 10: Types of ATEs, by year, related to IVIG (N=267). 22 Types of ATEs 23 Table 11 (A,B,C): Acute Hemolytic Transfusion Reactions, (AHTR): Relationship, severity and outcome (N=65). 23 Figure 11: Number of AHTR cases per year, by blood product transfused (N=65). 24 Table 12 (A,B,C): Delayed Hemolytic Transfusion Reactions (DHTR): Relationship, severity and outcome (N=136). 25 Figure 12: Number of DHTR cases per year, by blood product transfused (N=136). 26 Table 13 (A,B,C): Severe /Anaphylactic/Allergic Reactions: Relationship, severity and outcome (N=151). 27 Figure 13: Number of Severe Allergic / Anaphylactic / Anaphylactoid cases per year (N=151). 28 Table 14 (A,B,C): TRALI and Possible TRALI: Relationship, severity and outcome (N=39). 29 Figure 14: Number of TRALI and possile TRALI per year, by blood product transfused (N=39). 30 Table 15 (A,B,C): Transfusion-Associated Dyspnea (TAD): Relationship, severity and outcome (N=34). 31 Figure 15: Number of TAD cases per year, by blood product transfused (N=34). 32 Table 16 (A,B,C): Transfusion-Associated Circulatory Overload: Relationship, severity and outcome (N=302) 33 Figure 16: Number of Transfusion-Associated Circulatory Overload (TACO) cases per year (N=302). 34 Table 17A: ATEs by blood product and outcome 35 Table 17B: ATEs reported for outcome of transfusion-related death (N=17) 35 Appendices 36 Appendix 1: List of Reportable and Non reportable transfusion reactions. 36 Appendix 2: List of Abbreviations. 36 Appendix 3: List of Surveillance Definitions. 37 ii P a g e

4 Table of Contents Suggested Citation: Ontario Transfusion Transmitted Injuries Surveillance System (TTISS) Program Report: McMaster Transfusion Research Program, McMaster University, August 2017 Ontario TTISS 5 year report working committee: Nancy Heddle, MSc, FSCML (D) Director, McMaster Transfusion Research Program Professor, Department of Medicine McMaster University heddlen@mcmaster.ca Christine M Cserti-Gazdewich, MD, FRCPC, FASCP Transfusion Medicine Specialist & Consultant Hematologist University Health Network Christine.Cserti@uhn.ca Allison Collins MD FRCPC Transfusion Medicine Physician ORBCoN allison.collins@sw.ca Ana Lima, R.N. H.P. (ASCP) Transfusion Safety Nurse Sunnybrook Health Sciences Centre ana.lima@sunnybrook.ca Joanne Duncan, HRM, MSc. Ontario TTISS Coordinator McMaster University duncanj@mcmaster.ca Kayla Lucier, BAS TTISS Research Assistant McMaster University lucierkj@mcmaster.ca To obtain electronic copies, contact: Joanne Duncan, TTISS Ontario Coordinator duncanj@mcmaster.ca or Onttiss@mcmaster.ca iii P a g e

5 Acknowledgement Acknowledgement Ontario s contribution to Canada s Transfusion Transmitted Injuries Surveillance System (TTISS) relies on the voluntary involvement of hospitals to report adverse transfusion events. Ontario created their first 5 year provincial TTISS report This report is for In the last five years, we have grown in Ontario to include twice as many hospitals. This could not have been possible without the continuing participation of committed healthcare professionals responsible for reporting these adverse transfusion events and the input of those transfusion specialists involved in teaching, training and guiding practices in transfusion safety. Thank you for recognizing the importance of the program and contributing your time and effort to support TTISS and provide data on an ongoing basis. Without your cooperation and collaboration, this report would not be possible. I would also like to express my gratitude to the Blood Safety Contribution Program, Public Health Agency of Canada and Ontario s Blood Programs Coordinating Office at the Ministry of Health and Long-Term Care. They have provided us with funding, guidance and support throughout the program. In addition, many thanks to colleagues and staff at the Canadian Blood Services and ORBCoN for providing us with an avenue to grow and disseminate information on their websites and facilitating our many annual meetings with great hospitality. Lastly, many thanks to the staff at Ontario s TTISS Coordinating Centre, located at McMaster University in Hamilton, including coordinators, biostatisticians and data entry personnel. Nancy Heddle, MSc FSCML (D) Professor, Department of Medicine Director, McMaster Transfusion Research Program, McMaster University heddlen@mcmaster.ca 4 P a g e

6 Executive Summary Executive Summary Transfusion Transmitted Injuries Surveillance System (TTISS) is a national hemovigilance system implemented by the Public Health Agency of Canada (PHAC) to monitor serious, moderate and selected minor adverse transfusion events (ATEs) related to blood components and plasma derivatives. The Ministry of Health and Long-Term Care (MOHLTC) in Ontario and the Public Health Agency of Canada (PHAC) contracts the McMaster Transfusion Research Program at McMaster University to coordinate the TTISS activities in the Province of Ontario. The program is designed to capture ATEs related to all blood products comprised of blood components (red cells, plasma, platelets, cryoprecipitate) and plasma derivatives (immunoglobulin preparations, coagulation factors, and albumin). There are 155 hospitals that transfuse blood products in Ontario. This report summarizes ATEs received from 96 Ontario hospitals that voluntarily participated in the TTISS between 2012 to Transfusion activity at these 96 hospitals represent approximately 73.3% of the blood components given in Ontario. All TTISS participating hospitals submit reportable ATEs (reportable ATEs exclude minor allergic, delayed serological and febrile non-hemolytic reactions). A subgroup of 30 hospitals, referred to as sentinel sites, report all ATEs including the non-reportable reactions listed above. The comprehensive reporting by sentinel sites allows for a risk calculation for only blood components. The figures provided on pages of this report illustrate the risk of different types of reactions by blood component type. Health care personnel should find this information helpful when informing patients about transfusion related adverse events. The report is divided into five sections consisting of an acknowledgment, executive summary, methodology, main report and appendices. The main report describes ATEs in connection to the following: blood products; blood components; sentinel sites and risk estimates; plasma derivatives; specific reaction types; and, number of deaths. There were 1,040 reportable ATEs (collected from all sites) and 1,930 non-reportable ATEs (collected from sentinel sites only), for a total of 2,970 ATEs submitted to TTISS Ontario between 2012 to Of the 1,040 reportable reactions from all TTISS participating sites, 733 (70.5%) were related to blood components, 297 (28.6%) related to plasma derivatives and 10 (1.0%) were from a combination of both blood components and plasma derivatives. Red blood cells were implicated in 503 (68.6%) of the reactions to blood components. ATEs associated with plasma derivatives were most frequently reported with IVIG (267; 89.9%). The most frequent ATEs reported were; transfusion associated circulatory overload (TACO) reactions (n = 302, 29.0%), severe allergic/anaphylactic/anaphylactoid reactions (n = 151, 14.5%), and delayed hemolytic transfusion reactions (DHTR), (n = 136, 13.1%). There were 170 (16.3%) ATEs not categorized and reported as other or unknown. Overall, 538 (51.7%) of the 1,040 reportable ATEs were severe or life threatening; 423 (78.6%) were related to blood components and 109 (20.3%) were related to plasma derivatives. Forty-five deaths were reported, of which 17 were related to transfusion. 12 of these deaths were associated with blood components, 4 with plasma derivatives, and 1 with both types of products. 5 P a g e

7 Executive Summary Figure i. Summary of ATEs to blood components and plasma derivatives reported by Ontario hospitals participating in TTISS. Ontario Hospitals N=155 Hospitals participating in TTISS N=96 2,970 ATEs Hospitals reporting only PHAC Reportable ATEs N= ATEs Sentinel Site Hospitals reporting all Events N=30 2,429 ATEs PHAC Reportable ATEs Blood 375 ATEs Plasma Derivatives 157 ATEs Both Product Types 9 ATEs 541 ATEs PHAC Reportable ATEs Blood 358 ATEs Plasma Derivatives 140 ATEs Both Product Types 1 ATEs 499 ATEs Non-Reportable ATEs (minor)* Blood 1,725 ATEs Plasma Derivatives 201 ATEs Both Product Types 4 ATEs 1,930 ATEs PHAC Reportable ATEs For all blood PHAC products Reportable all TTISS ATEs participating hospitals For all blood Blood products all TTISS 733 ATEs participating Plasma hospitals Derivatives 297 ATEs Both 872 Product ATEs Types 10 ATEs 1,040 ATEs *Includes FNHTR, minor allergic, and delayed serological transfusion reactions 6 P a g e

8 Methodology Methodology Ontario transfuses 44% of the blood components (red cells, plasma, platelets, cryoprecipitate) used in Canada (based on 2012 to 2015 numbers). A total of 2,587,456 blood components were transfused by 159 Ontario hospitals from Forty nine of the 159 hospitals participate in TTISS and transfused 66.0% (1,835,150) of those blood components over the 5 year period. Adverse transfusion reactions associated with blood transfusion are reported to the laboratory at individual hospital sites. These reactions are identified, severity is established and imputability determined using the national definitions. Imputability is categorized as definitely, probably, possibly, doubtful, ruled out or not determined. For purposes of this report, those defined as doubtful and ruled out were not included. If the reaction is reportable according to the TTISS guidelines provided by PHAC, it is submitted to the Ontario TTISS office either by fax or by direct entry into a web based database. Submitted data does not include personal identifying information. The data are reviewed and assessed for completeness by the Ontario TTISS office staff. If additional information is required, the submitting hospital is contacted to provide the missing information. Cases initially classified as Unknown or Other are reviewed and, when possible, reclassified. Those cases that remain Unknown or Other were grouped together for this report to create one single new category of Other/Unknown pain. Adverse event data are submitted to PHAC twice a year by the Ontario TTISS office. There is always a 6 months delay in submitting data which allows time for hospitals to review and complete their cases. A subgroup of hospitals (n=30) referred to as the sentinel sites also submit non-reportable reactions (minor allergic, delayed serological, febrile non hemolytic). Participating hospitals are required to provide the number of each blood component transfused annually allowing for a calculation of reaction risk per product transfused. The risk of ATEs associated with plasma derivatives is not calculated as hospitals do not report the denominator data for these products. Figure ii: Ontario transfusion activity: Number of blood components transfused Ontario hospitals (155 hospitals) N=2,587,456 blood components transfused 100% Ontario TTISS participating hospitals sites (96 hospitals) N=1,897,149 blood components transfused 73.3% Ontario TTISS sentinel sites (30 hospitals) N=842,306 blood components transfused 32.6% 7 P a g e

9 Number of ATEs Blood Products 733 ATEs Blood Products and ATEs Table 1A: Adverse Transfusion Events (ATEs), N (%) by type of product and year. PHAC Reportable ATEs For all blood products at all TTISS participating hospitals Blood 733 ATEs Plasma Derivatives 297 ATEs Both Product Types 10 ATEs 1,040 ATEs Type of Transfused Product N % N % N % N % N % N % Blood Plasma Derivatives Both Product Types , Figure 1: ATEs related to transfused products per year (N=1,041). Overall, 70.5% of ATEs reported to TTISS were associated with blood components Yearly Number of ATEs by Transfused Product TTISS Hospitals Year 96 TTISS Hospitals Number of ATEs reported has increased over the past 5 years due to increasing participation in TTISS (from 49 to 96 hospitals). Blood Plasma Derivatives 8 P a g e

10 Blood Products 733 ATEs Table 1B: Number and percent of ATEs by reaction type for blood components and plasma derivatives, N (%). Majority of ATEs are associated with blood components. The most frequently reported ATEs are TACO (29.0%), other/unknown pain (16.3%), and severe allergic reactions (14.5%). Adverse Transfusion Reaction Blood Component Plasma Derivative Both Product Types of All Products N % N % N % N % Acute Hemolytic Transfusion Reaction Delayed Hemolytic Transfusion Reaction Anaphylactic Shock Severe Allergic /Anaphylactic/Anaphylactoid Aseptic Meningitis Bacterial Infection TRALI Possible TRALI TAD TACO Hypotensive Reaction IVIG Headache PTP Component Other/Unknown Pain Hemochromatosis , Ontario TTISS Report P a g e

11 Number of blood components transfused Transfusion Activity Transfusion Activity Table 2: Blood component transfusion activity in all Ontario hospitals (N=155) compared to those participating in TTISS (N=96). Ontario transfuses approximately 43% of blood components transfused in Canada. 2,587,456 blood components were transfused in Ontario from 2012 to TTISS participating hospitals represent approximately 73.3% of blood components transfused overall, but increasing participation showed 85.0% in hospitals collect reportable ATEs (excludes minor allergic, delayed serologic and febrile nonhemolytic reactions), with a subgroup of 30 hospitals, referred to as sentinel sites, collecting all ATEs. Blood Component Blood Transfused by All Ontario 155 Hospitals Blood Transfused by all 96 TTISS Reporting Hospitals Blood Transfused by the 30 Sentinel TTISS Hospitals N % N % Red Blood Cells (RBC ) 1,898,188 1,305, , Plasma 266, , , Plasma (Apheresis) 35,039 27, , Platelets 167, , , Platelets (Apheresis) 69,183 61, , Cryoprecipitate 150, , , ,587,456 1,897, , Figure 2: Number of units of blood components transfused by year. 600, , , , , , , , , , , , , , % 357, % 190, % 167, % 516, , % 350, % 169, % 490, , , % 427, % 158, % Year ALL Ontario hospitals TTISS reporting hospitals Sentinel hospitals 10 P a g e

12 Blood 733 ATEs Blood and ATEs Figure 3: Blood components that were associated with ATEs (N=733). PHAC Reportable ATEs For all blood products at all TTISS participating hospitals Blood 733 ATEs Plasma Derivatives 297 ATEs Both Product Types 10 ATEs 1,040 ATEs Platelets, N= % Cryoprecipitate, N=1 0.1% Multiple Blood, N=50 6.8% 503 (68.6%) ATEs were associated with Red Blood Cells. Plasma, N=53 7.2% RBC, N= % Table 3: Number N (%) ATEs associated with each blood component per year (N=733). Blood Component N % N % N % N % N % N % Red Blood Cells Plasma Platelets Cryoprecipitate Multiple Blood P a g e

13 Blood 733 ATEs Figure 4: Relationship of ATEs to blood components (N=733). Probable N= % Definite N= % 456 (62.2%) of the ATEs were definitely or probably related to the blood component transfused. Not N=13 1.8% Possible N= % Table 4: Number and relationship of ATEs from to blood component type. Blood Component Definite Probably Possible Not N % N % N % N % N % RBC Plasma Platelets Cryoprecipitate Multiple Blood P a g e

14 Blood 733 ATEs Figure 5: Severity of ATEs for all blood components (N=733). Grade 3 (Life threatening) N= % Not N=11 1.5% 423 (57.7%) of the ATEs were severe or life threatening. Grade 1 (Non-Severe) N= % Grade 2 (Severe) N= % Table 5A: Severity of ATEs by year for all blood component types. Severity N % N % N % N % N % N % Grade 1 (Non-Severe) Grade 2 (Severe) Grade 3 (Life threatening) Not Table 5B: Severity of ATEs by blood component type. Blood Component Grade 3 (Life threatening) Grade 2 (Severe) Grade 1 (Non- Severe) Not N % N % N % N % N % RBC Plasma Platelets Cryoprecipitate Multiple Blood P a g e

15 Blood 733 ATEs Figure 6: Outcome of ATEs for all blood components (N=733). Death Not if Related to Transfusion N=6 0.8% Death Not Related to Transfusion (Doubtful, Ruled out) N=20 2.7% Not N=37 5.0% There were 38 deaths reported of which 12 cases (1.6%) were believed to be related to the transfusion involving blood components. Death Related to Transfusion (Definite, Probable, Possible) N=12 1.6% Major or Long-Term Sequelae N=43 5.9% Minor or No Sequelae N= % Table 6A: Outcome of ATEs per year for all blood component types N % N % N % N % N % N % Death Related to Transfusion (Definite, Probable, Possible) Major or Long-Term Sequelae Minor or No Sequelae Death Not Related to Transfusion (Doubtful, Ruled out) Death Not if Related to Transfusion Not Table 6B: Outcome of ATEs by each blood component type. Blood Component Death Related to Transfusion Major or Long-Term Sequelae Minor or No Sequelae Death Not Related to Transfusion Death Not if Related to Transfusion Not N % N % N % N % N % N % N % RBC Plasma Platelets Cryoprecipitate Multiple Blood P a g e

16 Blood 733 ATEs Table 7A: Type of ATE summarized by individual blood component type (N=733). Adverse Transfusion Reaction Acute Hemolytic Transfusion Reaction (AHTR) RBC Plasma Platelets Cryoprecipitate Multiple Blood N % N % N % N % N % N % Delayed Hemolytic Transfusion Reaction (DHTR) Anaphylactic Shock Severe Allergic/Anaphylactic/ Anaphylactoid Bacterial Infection TRALI Possible TRALI TAD TACO Hypotensive Reaction PTP Component Other/Unknown Pain Hemochromatosis P a g e

17 Blood 733 ATEs Table 7B: Relationship of the ATE by reaction type for blood components (N=733). Adverse Transfusion Event Acute Hemolytic Transfusion Reaction Delayed Hemolytic Transfusion Reaction Definite Probable Possible Not N % N % N % N % N % Anaphylactic Shock Severe Allergic/Anaphylactic/ Anaphylactoid Bacterial Infection TRALI Possible TRALI TAD TACO Hypotensive Reaction PTP Component Other/Unknown Pain Hemochromatosis P a g e

18 Blood 733 ATEs Figure 8: Number of ATEs per year by reaction type for blood components (N=733) P a g e

19 Risk Estimate - Sentinel Site ATE Risk Calculations Risk of experiencing a transfusion reaction to a blood component The sentinel sites (30 of the 96 participating TTISS sites) report all transfusion reactions. The sentinel sites account for 44.4% of the transfusion activity captured by TTISS participating sites. There were 2,429 ATEs were reported from the sentinel sites, of which 1,930 of these were considered non-reportable according to PHAC guidelines, and include febrile non hemolytic, minor allergic and delayed serologic reactions. There were 499 reportable ATEs. Reporting of all ATEs by the sentinel site allowed for risk estimates to be calculated. To make this calculation, the 30 sentinel sites were asked to provide denominator data for each type of blood component transfused. Table 8A: Number of blood components transfused at the sentinel sites. Blood Component *Percentage of the total products transfused in Ontario Table 8B: Number of ATEs by type of blood component and risk estimate. Blood Component Sentinel Site Reportable ATEs All TTISS Reporting Hospitals N=96 Sentinel Site Non- Reportable ATEs Sentinel Site Sentinel Sites Transfusion Sentinel Sites N=30 %* Red Blood Cells (RBC) 1,305, , Frozen Plasma 229, , Plasma (Apheresis) 27,873 13, Pooled Platelets 138,752 54, Platelets (Apheresis) 61,428 30, Cryoprecipitate 134,406 64, ,897, , Risk per Product Transfused Red Blood Cells (RBC) ,916 1:403 All Plasma ,549 1:880 All Platelets ,972 1:190 Cryoprecipitate ,869 1:1,297 Multiple Blood ,306 1: P a g e

20 Risk Estimate Summary Sentinel Sites Table 8C: Risk of an ATE by Blood Component and Type of Reaction. Adverse Transfusion Event Red Blood Cells (564,916) Plasma (127,549) Platelets (84,972) Cryoprecipitate (64,869) Multiple Blood (842,306) N Risk N Risk N Risk N Risk N Risk N Risk Acute Hemolytic Reaction 17 1:33, :84, :46,795 Delayed Hemolytic Reaction 41 1:13, :20,544 Anaphylactic Shock :42, :84, :168,461 Severe Allergic 11 1:51, :6, :2, :13,370 Bacterial Infection 2 1:282, :127, :42, :168,461 TRALI 1 1:564, :421,153 Possible TRALI 3 1:188, :63, :21, :70,192 TAD 6 1:94, :127, :120,329 TACO 112 1:5, :31, :10, :5,932 Hypotensive Reaction 14 1:40, :28, :49,547 PTP :842,306 Other/Unknown Pain 30 1:18, :63, :8, :64, :19,143 Delayed Serological Transfusion Reaction (new alloantibodies) 386 1:1, :28, :2,132 Febrile Non Hemolytic Reaction 598 1: :8, : :1,138 Minor Allergic Reaction 181 1:3, :1, : :16, :1,428 Hemochromatosis 1 1:564, :842,306 (Risk of Any Type of ATE) 1,403 1: : : : ,083 1: P a g e

21 Plasma Derivatives Plasma Derivatives Table 9: Number (%) of ATEs, by year, related to plasma derivatives (N=297). PHAC Reportable ATEs All blood products at all TTISS participating hospitals Blood 733 ATEs Plasma Derivatives 297 ATEs Both Product Types 10 ATEs 1,040 ATEs Type of Transfuse d Product N % N % N % N % N % N % IVIG Albumin Coagulation Factor RhIg Other Ig Figure 9: ATEs related to plasma derivatives (N=297). Coagulation Factor N=3 1.0% RhIg N=1 0.3% Other Ig N=16 5.4% 267 (89.9%) ATEs attributed to Plasma Derivatives occur with IVIG. Albumin N=10 3.4% IVIG N= % 20 P a g e

22 Intravenous Immunoglobin (IVIG) Figure 10A: Relationship of ATEs related to IVIG (N=267). Probable N= % Definite N= % Possible N= % Figure 10B: Severity of ATEs related to IVIG (N=267) Grade 3 (Lifethreatening) N=6 2.2% Not N=2 0.7% Grade 2 (Severe) N= % Grade 1 (Non-Severe) N= % Figure 10C: Outcome of ATEs related to IVIG (N=267). Not N=4 1.5% Death Not if Related to Transfusion N=1 0.4% Death Related to Transfusion N=2 0.7% Major or Long-Term Sequelae N=8 3.0% Minor or No Sequelae N= % 21 P a g e

23 Intravenous Immunoglobin (IVIG) Table 10: Types of ATEs related to IVIG by year (N=267). Adverse Transfusion Reactions N % N % N % N % N % N % Acute Hemolytic Transfusion Reaction Delayed Hemolytic Transfusion Reaction Severe Allergic/Anaphylactic/Anaphylactoid Aseptic Meningitis Bacterial Infection TAD TACO Hypotensive Reaction IVIg Headache Other/Unknown Pain Ontario TTISS Report P a g e

24 Type of ATE - AHTR Type of ATE Table 11: Acute Hemolytic Transfusion Reactions (AHTR), (N=65). Most AHTRs occur with RBCs (49.2%) and IVIG (36.9%). Table 11A: Relationship of AHTR to Transfusion Type of Blood Product Definite Probable Possible Not N % N % N % N % N % Red Blood Cells Platelets IVIG RhIg Multiple Blood Blood/Derivatives Table 11B: Severity of AHTR Type of Product Grade 3 (Life threatening) Grade 2 (Severe) Grade 1 (Non-Severe) Not N % N % N % N % N % Red Blood Cells Platelets IVIG RhIg Multiple Blood Blood/Derivatives P a g e

25 Type of ATE - AHTR Table 11: Acute Hemolytic Transfusion Reactions (AHTR), (N=65). Table 11C: Outcome of AHTR Type of Blood Product Death Major or Long-Term Sequelae Minor or No Sequelae Not N % N % N % N % N % Red Blood Cells Platelets IVIG RhIg Multiple Blood Blood/Derivatives Figure 11: Number of AHTR cases per year, by blood product transfused (N=65) Blood Plasma Derivatives Both 24 P a g e

26 Type of ATE - DHTR Table 12: Delayed Hemolytic Transfusion Reactions (DHTR), (N=136). Table 12A: Relationship of DHTR to Transfusion Type of Blood Product Definite Probable Possible N % N % N % N % Red Blood Cells IVIG Other Immune Globulin Blood/Derivatives Table 12B: Severity of DHTR Type of Blood Product Grade 3 (Life threatening) Grade 2 (Severe) Grade 1 (Non-Severe) Not N % N % N % N % N % Red Blood Cells IVIG Other Immune Globulin Blood/Derivatives P a g e

27 Type of ATE - DHTR Table 12: Delayed Hemolytic Transfusion Reactions (DHTR), (N=136). Table 12C: Outcome of DHTR Type of Blood Product Major or Long-Term Sequelae Minor or No Sequelae Death Possibly Related to Transfusion Not N % N % N % N % N % Red Blood Cells IVIG Other Immune Globulin Blood/Derivatives Figure 12: Number of DHTR cases per year, by blood product transfused (N=136) Blood Plasma Derivatives Both 26 P a g e

28 Type of ATE - Severe Allergic Table 13: Severe Allergic / Anaphylactic / Anaphylactoid Reactions (N=151). Table 13A: Relationship of Severe Allergic / Anaphylactic / Anaphylactoid to Transfusion Type of Blood Product Definite Probable Possible N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood IVIG Other Ig Coagulation Factor Albumin Blood/Derivatives Table 13B: Severity of Severe Allergic / Anaphylactic / Anaphylactoid Reaction Type of Blood Product Grade 3 (Life Grade 2 Grade 1 Not threatening) (Severe) (Non-Severe) N % N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood IVIG Other Ig Coagulation Factor Albumin Blood/Derivatives P a g e

29 Type of ATE - Severe Allergic Table 13: Severe Allergic / Anaphylactic / Anaphylactoid Reactions (N=151). Table 13C: Outcome of Severe Allergic / Anaphylactic / Anaphylactoid Type of Blood Product Red Blood Cells Major or Long-Term Sequelae Minor or No Sequelae Death Not related to Transfusion Not N % N % N % N % N % Plasma Platelets Multiple Blood IVIG Other Ig Coagulation Factor Albumin Blood/Derivatives Figure 13: Number of Severe Allergic / Anaphylactic / Anaphylactoid cases per year, by blood product transfused (N=151) Blood Plasma Derivatives Both 28 P a g e

30 Type of ATE TRALI & Possible TRALI Table 14: Transfusion-Related Acute Lung Injury TRALI (N=10) and Possible TRALI (N=29). TRALI and Possible TRALI (N=39). Table 14A: Relationship of TRALI and Possible TRALI to Transfusion Type of Blood Product Definite Probable Possible Not N % N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood Table 14B: Severity of TRALI and Possible TRALI Type of Blood Product Grade 3 (Life threatening) Grade 2 (Severe) Grade 1 (Non- Severe) Not N % N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood P a g e

31 Type of ATE TRALI & Possible TRALI Table 14: Transfusion-Related Acute Lung Injury (TRALI and Possible TRALI), (N=39). Table 14C: Outcome of TRALI and Possible TRALI Reactions Type of Blood Product Death Related to Transfusion Major or Long-Term Sequelae Minor or No Sequelae Death Not related to Transfusion Death Not if Related to Transfusion Not N % N % N % N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood Figure 14: Number of ATEs of TRALI and Possible TRALI by year, by blood product transfused (N=39) Blood 30 P a g e

32 Type of ATE - TAD Table 15: Transfusion-Associated Dyspnea (TAD), (N=34). Table 15A: Relationship of TAD to Transfusion Type of Blood Product Definite Probable Possible N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood IVIG Table 15B: Severity of TAD Type of Blood Product Grade 3 (Life threatening) Grade 2 (Severe) Grade 1 (Non-Severe) N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood IVIG P a g e

33 Type of ATE - TAD Table 15: Transfusion-Associated Dyspnea (TAD), (N=34). Table 15C: Outcome of TAD Type of Blood Product Major or Long- Term Sequelae Minor or No Sequelae Death Not related to Transfusion Not N % N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood IVIG Figure 15: Number of Transfusion-Associated Dyspnea (TAD) per year, by blood product transfused (N=34) Blood Plasma Derivatives 32 P a g e

34 Type of ATE - TACO Table 16: Transfusion-Associated Circulatory Overload (TACO), (N=302). Table 16A: Relationship of TACO to Transfusion Not Definite Probable Possible Type of Blood Product N % N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood IVIG Albumin Blood/Derivatives Table 16B: Severity of TACO Type of Blood Product Grade 3 (Life threatening) Grade 2 (Severe) Grade 1 (Non-Severe) Not N % N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood IVIG Albumin Blood/Derivatives P a g e

35 Type of ATE - TACO Table 16: Transfusion-Associated Circulatory Overload (TACO), (N=302). Table 16C: Outcome of TACO Type of Blood Product Death Related to Transfusion Major or Long-Term Sequelae Minor or No Sequelae Death Not related to Transfusion Death Not if Related to Transfusion Not N % N % N % N % N % N % N % Red Blood Cells Plasma Platelets Multiple Blood IVIG Albumin Blood/ Derivatives Figure 16: Number of Transfusion-Associated Circulatory Overload (TACO) per year by blood product transfused (N=302) Blood Plasma Derivatives Both 34 P a g e

36 Deaths Table 17A: ATE by blood product type and outcomes Type of Blood Product Blood Plasma Derivatives Both Product Types Death Related to Transfusion Major or Long-Term Sequelae Blood Product and Outcome of ATE to Transfusion Minor or No Sequelae Death Not Related to Transfusion Death Not if Related to Transfusion Not N % N % N % N % N % N % N % , Table 17B: ATEs reported for outcome of transfusion-related death (N=17) Relationship of Transfusion to Recipient s Death Adverse Transfusion Events Definite Probable Possible Acute Hemolytic Transfusion Reaction (AHTR)** Delayed Hemolytic Transfusion Reaction (DHTR) N % N % N % N % Bacterial Infection TRALI Possible TRALI TACO Other/Unknown Pain ** Two of the four AHTR were as a result of an incompatible transfusion 35 P a g e

37 Appendices Appendices Appendix 1 List of Reportable and Non Reportable Transfusion Reactions Reportable ATEs Acute Hemolytic Transfusion Reaction Delayed Hemolytic Transfusion Reaction Anaphylactic Shock Severe/Anaphylactic/Anaphylactoid Aseptic Meningitis Bacterial Infection Viral Infection Other Infection Transfusion Related Acute Lung Injury (TRALI) Possible TRALI Transfusion Associated Dyspnea (TAD) Transfusion Associated Circulatory Overload (TACO) Hemochromatosis Reportable ATEs Incompatible Transfusion Reactions Post Transfusion Purpura (PTP) Hypotensive Reaction Intravenous immunoglobulin (IVIg) headache Other/Unknown Pain Reaction TA-GVHD Severe Allergic/Anaphylactic/Anaphylactoid Non-Reportable ATEs Delayed Serological Transfusion Reaction Febrile Non Hemolytic Reaction Minor Allergic Reaction Appendix 2 List of Abbreviations AHTR ATE CBS DHTR MOHLTC ORBCoN PHAC Possible TRALI PTP RBC TACO TAD TRALI TTISS IVIG Acute Hemolytic Transfusion Reaction Adverse Transfusion Event Canadian Blood Services Delayed Hemolytic Transfusion Reaction Ministry of Health and Long-term Care Ontario Regional Blood Coordinating Network Public Health Agency of Canada Possible Related Acute Lung Injury Post-Transfusion Purpura Red Blood Cells Transfusion Associated Circulatory Overload Transfusion Associated Dyspnea Transfusion Related Acute Lung Injury Transfusion Transmitted Injuries Surveillance System Intravenous Immunoglobulin 36 P a g e

38 Appendices Appendix 3 List of Surveillance Definitions 1 Relationship to Product (Imputability) Definite Probable Possible Clinical and/or laboratory event within a time frame consistent with the administration of the blood, blood component or plasma derivative and was proven by investigation to have been caused by transfusion. Clinical and/or laboratory event occurred within a time frame consistent with the administration of the blood, blood component or plasma derivative and did not seem to be explainable by any other cause. Clinical and/or laboratory event occurred within a time frame consistent with the administration of the blood, blood component or plasma derivative but could be explained by concurrent disease(s) or by the administration of a drug or other agent. Severity: Severity was initially classified into four categories including death (as Grade 4) which was subsequently reclassified as life-threatening. The death was categorized as an outcome and relationship between transfusion and death was assessed. Life-threatening (Grade 3) Severe (Grade 2) Non-severe (Grade 1) Outcome Death Major or long-term sequelae Minor or no sequelae The recipient required major intervention following the transfusion (i.e. vasopressors, intubation, and transfer to intensive care). The recipient required in-patient hospitalization or prolongation of hospitalization directly attributable to the event; or the adverse event resulted in persistent or significant disability or incapacity; or the adverse event necessitated medical or surgical intervention of preclude permanent/significant damage or impairment of body function. The recipient may have required medical intervention (i.e. symptomatic treatment) but lack of such would not result in permanent damage or impairment of body function. Death was directly or indirectly transfusion-related. Transfused patient developed an infection with persistent infectious agent or any other long-term sequelae including difficulties with future transfusions. Transfused patient developed antibodies to lowmedium frequency antigens or any other minor reaction 1 Public Health Agency of Canada. TTISS Report, Centre for Communicable Diseases and Infection Control, PHAC, P a g e