Transfusion Transmitted Injuries Surveillance System (TTISS)

2006-2012 Summary Results

2006-2012 Summary Results

Table 1A. Adverse reactions resulting from transfusion of blood components and plasma derivatives, TTISS 2006-2012
Type of transfusion-related < adverse reaction 2006 2007 2008 2009 2010 2011 2012 Total
Freq. % Freq. % Freq. % Freq. % Freq. % Freq. % Freq. % Freq. %
1 Other = Transfusion-related adverse reactions which are well described (in the literature), but rarely occurred.
2 Unusual reactions = Adverse reactions that were definitely related to transfusion, but did not fit into any other categorization. These are new and unexpected reactions/effects of clinical significance
Transfusion-associated circulatory overload -TACO 169 36.6% 166 39.4% 181 31.3% 149 32.0% 190 30.7% 223 34.7% 220 28.6% 1,298 32.8%
Acute hemolytic reaction 36 7.8% 11 2.6% 32 5.5% 25 5.4% 32 5.2% 24 3.7% 31 4.0% 191 4.8%
Severe allergic anaphylactic/
anaphylactoid reaction
63 13.6% 60 14.3% 63 10.9% 65 14.0% 96 15.5% 61 9.5% 97 11.3% 495 12.5%
Hypotensive reaction 49 10.6% 47 11.2% 51 8.8% 41 8.8% 44 7.1% 37 5.8% 67 8.7% 336 8.5%
Delayed hemolytic reaction 24 5.2% 22 5.2% 58 10.0% 65 14.0% 62 10.0% 71 11.1% 84 10.9% 386 9.8%
Transfusion-related acute lung injury - TRALI 18 3.9% 17 4.0% 7 1.2% 10 2.2% 8 1.3% 13 2.0% 8 1.0% 81 2.0%
Possible TRALI 4 0.9% 1 0.2% 14 2.4% 9 1.9% 13 2.1% 9 1.4% 13 1.7% 63 1.6%
Transfusion-associated dyspnea -TAD 15 3.2% 8 1.9% 25 4.3% 19 4.1% 40 6.5% 19 3.0% 24 3.1% 150 3.8%
IVIG headache 3 0.6% 22 5.2% 48 8.3% 24 5.2% 39 6.3% 54 8.4% 105 13.7% 2 95 7.5%
Aseptic meningitis 3 0.6% 3 0.7% 6 1.0% 1 0.2% 10 1.6% 3 0.5% 13 1.7% 39 1.0%
Incompatible transfusion 3 0.6% 5 1.2% 12 2.1% 7 1.5% 7 1.1% 10 1.6% 10 1.3% 54 1.4%
Bacterial infection 3 0.6% 2 0.5% 5 0.9% 4 0.9% 7 1.1% 9 1.4% 3 0.4% 33 0.8%
Other Table 1 - Footnote 1 46 10.0% 41 9.7% 58 10.0% 37 8.0% 52 8.4% 98 15.3% 76 9.9% 408 10.3%
Unusual reactions Table 1 - Footnote 2 26 5.6% 16 3.8% 19 3.3% 9 1.9% 19 3.1% 11 1.7% 28 3.6% 128 3.2%
Total 462 100% 421 100% 579 100% 465 100% 619 100% 642 100% 769 100% 3,957 100%

Over the 2006-2012 period, transfusion-associated circulatory overload (TACO) and severe allergic anaphylactic/anaphylactoid reaction were the most commonly reported adverse reactions and accounted respectively for 32.8% and 12.5% of all the cases (Table 1A). This pattern was similar to that of those that received blood components (Table 1B), but different for those that received blood products (Table 1C) where headache and intolerance to intravenous immunoglobulin (IVIG; 28.5%) and delayed hemolytic reactions (16.9%) were the most frequently reported.

Table 1B. Adverse reactions related to transfusion of blood components, TTISS 2006 - 2012
Type of transfusion-related adverse reaction 2006 2007 2008 2009 2010 2011 2012 Total
Freq. % Freq. % Freq. % Freq. % Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload - TACO 163 40.4% 154 44.1% 173 41.1% 142 41.9% 185 40.7% 216 48.0% 209 41.5% 1,242 42.5%
Acute hemolytic reaction 22 5.5% 7 2.0% 20 4.8% 14 4.1% 16 3.5% 15 3.3% 15 3.0% 109 3.7%
Severe allergic anaphylactic/
anaphylactoid reaction
56 13.9% 54 15.5% 57 13.5% 50 14.7% 79 17.4% 50 11.1% 65 12.9% 411 14.1%
Hypotensive reaction 43 10.7% 43 12.3% 46 10.9% 34 10.0% 40 8.8% 30 6.7% 62 12.3% 298 10.2%
Delayed hemolytic reaction 17 4.2% 16 4.6% 34 8.1% 38 11.2% 31 6.8% 37 8.2% 38 7.5% 211 7.2%
Transfusion-related acute lung injury – TRALI 18 4.5% 17 4.9% 7 1.7% 9 2.7% 8 1.8% 12 2.7% 8 1.6% 79 2.7%
Possible TRALI 4 1.0% 1 0.3% 14 3.3% 9 2.7% 13 2.9% 8 1.8% 13 2.6% 62 2.1%
Transfusion-associated dyspnea – TAD 15 3.7% 7 2.0% 23 5.5% 16 4.7% 35 7.7% 18 4.0% 20 4.0% 134 4.6%
Incompatible transfusion 3 0.7% 5 1.4% 12 2.9% 7 2.1% 6 1.3% 8 1.8% 10 2.0% 51 1.7%
Bacterial infection 3 0.7% 2 0.6% 5 1.2% 4 1.2% 7 1.5% 9 2.0% 3 0.6% 33 1.1%
Other 39 9.7% 33 9.5% 18 4.3% 7 2.1% 21 4.6% 39 8.7% 36 7.1% 193 6.6%
Unusual reactions 20 5.0% 10 2.9% 12 2.9% 9 2.7% 13 2.9% 8 1.8% 25 5.0% 97 3.3%
Total 403 100% 349 100% 421 100% 339 100% 454 100% 450 100% 504 100% 2,920 100%
Table 1C. Adverse reactions related to transfusion of blood products (plasma derivatives), TTISS 2006 - 2012
Type of transfusion-related adverse reaction 2006 2007 2008 2009 2010 2011 2012 Total
Freq. % Freq. % Freq. % Freq. % Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 6 10.2% 12 16.7% 8 5.1% 7 5.6% 5 3.0% 7 3.6% 11 4.2% 56 5.4%
Acute hemolytic reaction 14 23.7% 4 5.6% 12 7.6% 11 8.7% 16 9.7% 9 4.7% 16 6.1% 82 7.9%
Severe allergic anaphylactic/
anaphylactoid reaction
7 11.9% 6 8.3% 6 3.8% 15 11.9% 17 10.3% 11 5.7% 22 8.3% 84 8.1%
Hypotensive reaction 6 10.2% 4 5.6% 5 3.2% 7 5.6% 4 2.4% 7 3.6% 4 1.5% 37 3.6%
Delayed hemolytic reaction 7 11.9% 6 8.3% 24 15.2% 27 21.4% 31 18.8% 34 17.7% 46 17.4% 175 16.9%
Transfusion-related acute lung injury – TRALI 0 0.0% 0 0.0% 0 0.0% 1 0.8% 0 0.0% 1 0.5% 0 0.0% 2 0.2%
Possible TRALI 0 0.0% 0 0.0% 0 0.0% 0 0.0% 0 0.0% 1 0.5% 0 0.0% 1 0.1%
Transfusion-associated dyspnea – TAD 0 0.0% 1 1.4% 2 1.3% 3 2.4% 5 3.0% 1 0.5% 4 1.5% 16 1.5%
IVIG headache 3 5.1% 22 30.6% 48 30.4% 24 19.0% 39 23.6% 54 28.1% 105 39.8% 295 28.5%
Aseptic meningitis 3 5.1% 3 4.2% 6 3.8% 1 0.8% 10 6.1% 3 1.6% 13 4.9% 39 3.8%
Incompatible transfusion 0 0.0% 0 0.0% 0 0.0% 0 0.0% 1 0.6% 2 1.0% 0 0.0% 3 0.3%
Other 7 11.9% 8 11.1% 40 25.3% 30 23.8% 31 18.8% 59 30.7% 40 15.2% 215 20.8%
Unusual reactions 6 10.2% 6 8.3% 7 4.4% 0 0.0% 6 3.6% 3 1.6% 3 1.1% 31 3.0%
Total 59 100% 72 100% 158 100% 126 100% 165 100% 192 100% 264 100% 1,036 100%
N.B.
The total from Tables 1B and 1C do not add up to the overall total in Table 1A because of missing information on the type of blood product that was administered to one patient.
Table 2A. Relationship of adverse reaction (imputability) to transfusion of blood components & plasma derivatives, TTISS 2006-2012
Type of transfusion-related adverse reaction Definite Table 2a - Footnote 1 Probable Table 2a - Footnote 2 Possible Table 2a - Footnote 3 Total
Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 91 7.0% 594 45.8% 613 47.2% 1,298 100%
Acute hemolytic reaction 106 55.5% 59 30.9% 26 13.6% 191 100%
Severe allergic anaphylactic
/anaphylactoid reaction
76 15.4% 303 61.2% 116 23.4% 495 100%
Hypotensive reaction 10 3.0% 108 32.1% 218 64.9% 336 100%
Delayed hemolytic reaction 251 65.0% 96 24.9% 39 10.1% 386 100%
Transfusion-related acute lung injury – TRALI 16 19.8% 44 54.3% 21 25.9% 81 100%
Possible TRALI 6 9.5% 15 23.8% 42 66.7% 63 100%
Transfusion-associated dyspnea – TAD 9 6.0% 54 36.0% 87 58.0% 150 100%
IVIG headache 47 15.9% 190 64.4% 58 19.7% 295 100%
Aseptic meningitis 13 33.3% 19 48.7% 7 17.9% 39 100%
Incompatible transfusion 45 83.3% 5 9.3% 4 7.4% 54 100%
Bacterial infection 3 9.1% 6 18.2% 24 72.7% 33 100%
Other 24 5.9% 206 50.5% 178 43.6% 408 100%
Unusual reactions 2 1.6% 30 23.4% 96 75.0% 128 100%
Total 699 17.7% 1,729 43.7% 1,529 38.6% 3,957 100%
This report does not include cases for which the relationship with transfusion was either deemed doubtful Table 2a - Footnote 4 or ruled out Table 2a - Footnote 5.

Clinical and/or laboratory event occurred within a time frame consistent with the administration of the blood, blood component, or blood product (plasma derivative) and was proven by investigation to have been caused by transfusion.

2

Clinical and/or laboratory event occurred within a time frame consistent with the administration of the blood, blood component, or blood product (plasma derivative) and did not seem to be explainable by any other cause.

3

Clinical and/or laboratory event occurred within a time frame consistent with the administration of the blood, blood component, or blood product (plasma derivative) but could be explained by concurrent disease(s) or by the administration of a drug or other agent.

4

Clinical and/or laboratory event occurred within a reasonable time frame in relation to the transfusion but the preponderance of data supports an alternative explanation.

5

Clinical and/or laboratory event occurred within a time frame inconsistent with the administration of the blood, blood component, or blood product (plasma derivative), or if it occurred within a consistent time period but was proven to have no relationship to the transfusion.

Overall, only 17.7% (n = 699) of the cases were definitely linked to transfusion (Table 2A), while the remaining 82.3% were deemed to be probably (n = 1,729) or possibly (n = 1,529) related to transfusion. Over 63% (n = 443) of the cases definitely linked to transfusion were patients that received blood component (Table 2B).

Table 2B. Relationship of adverse reaction (imputability) to transfusion of blood components only, TTISS 2006-2012
Type of transfusion-related adverse reaction Definite Probable Possible Total
Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 90 7.2% 573 46.1% 579 46.6% 1,242 100%
Acute hemolytic reaction 60 55.0% 33 30.3% 16 14.7% 109 100%
Severe allergic anaphylactic/anaphylactoid reaction 51 12.4% 259 63.0% 101 24.6% 411 100%
Hypotensive reaction 7 2.3% 99 33.2% 192 64.4% 298 100%
Delayed hemolytic reaction 149 70.6% 48 22.7% 14 6.6% 211 100%
Transfusion-related acute lung injury – TRALI 15 19.0% 43 54.4% 21 26.6% 79 100%
Possible TRALI 6 9.7% 14 22.6% 42 67.7% 62 100%
Transfusion-associated dyspnea – TAD 8 6.0% 44 32.8% 82 61.2% 134 100%
Incompatible transfusion 45 88.2% 2 3.9% 4 7.8% 51 100%
Bacterial infection 3 9.1% 6 18.2% 24 72.7% 33 100%
Other 9 4.7% 84 43.5% 100 51.8% 193 100%
Unusual reactions 0 0.0% 18 18.6% 79 81.4% 97 100%
Total 443 15.2% 1,223 41.9% 1,254 42.9% 2,920 100%
Table 2C. Relationship of adverse reaction (imputability) to transfusion of blood products (plasma derivatives), TTISS 2006-2012
Type of transfusion-related adverse reaction Definite Probable Possible Total
Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 1 1.8% 21 37.5% 34 60.7% 56 100%
Acute hemolytic reaction 46 56.1% 26 31.7% 10 12.2% 82 100%
Severe allergic anaphylactic/anaphylactoid reaction 25 29.8% 44 52.4% 15 17.9% 84 100%
Hypotensive reaction 3 8.1% 8 21.6% 26 70.3% 37 100%
Delayed hemolytic reaction 102 58.3% 48 27.4% 25 14.3% 175 100%
Transfusion-related acute lung injury – TRALI 1 50.0% 1 50.0% 0 0.0% 2 100%
Possible TRALI 0 0.0% 1 100% 0 0.0% 1 100%
Transfusion-associated dyspnea – TAD 1 6.3% 10 62.5% 5 31.3% 16 100%
IVIG headache 47 15.9% 190 64.4% 58 19.7% 295 100%
Aseptic meningitis 13 33.3% 19 48.7% 7 17.9% 39 100%
Incompatible transfusion 0 0.0% 3 100.0% 0 0.0% 3 100%
Other 15 7.0% 122 56.7% 78 3 6.3% 215 100%
Unusual reactions 2 6.5% 12 38.7% 17 54.8% 31 100%
Total 256 24.7% 505 48.7% 275 26.5% 1,036 100%
N.B.
The total from Tables 2B and 2C do not add up to the overall total in Table 2A because of missing information on the type of blood product that was administered to one patient.
Table 3A. Severity of adverse reactions that resulted from transfusion of blood components & blood products (plasma derivatives), TTISS 2006 - 2012
Type of transfusion-related adverse reaction Grade 1 Table 3a - Footnote 1
(Non-severe)
Grade 2 Table 3a - Footnote 2
(Severe)
Grade 3 Table 3a - Footnote 3
(Life-threatening)
Not
determined Table 3a - Footnote 4
Total
Freq. % Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 604 29.9% 565 36.1% 94 34.8% 4 15.4% 1,267 32.6%
Acute hemolytic reaction 89 4.4% 83 5.3% 14 5.2% 3 11.5% 189 4.9%
Severe allergic anaphylactic/
anaphylactoid reaction
110 5.4% 332 21.2% 39 14.4% 1 3.8% 482 12.4%
Hypotensive reaction 209 10.3% 99 6.3% 17 6.3% 0 0.0% 325 8.4%
Delayed hemolytic reaction 252 12.5% 116 7.4% 5 1.9% 9 34.6% 38 9.8%
Transfusion-related acute lung injury – TRALI 6 0.3% 41 2.6% 32 11.9% 1 3.8% 80 2.1%
Possible TRALI 3 0.1% 36 2.3% 23 8.5% 0 0.0% 62 1.6%
Transfusion-associated dyspnea – TAD 86 4.3% 53 3.4% 11 4.1% 0 0.0% 150 3.9%
IVIG headache 259 12.8% 34 2.2% 0 0.0% 1 3.8% 294 7.6%
Aseptic meningitis 9 0.4% 27 1.7% 1 0.4% 1 3.8% 38 1.0%
Incompatible transfusion 29 1.4% 20 1.3% 3 1.1% 2 7.7% 54 1.4%
Bacterial infection 11 0.5% 16 1.0% 5 1.9% 1 3.8% 33 0.9%
Other 263 13.0% 117 7.5% 20 7.4% 3 11.5% 403 10.4%
Unusual reactions 9 1 4.5% 2 6 1.7% 6 2.2% 0 0.0% 123 3.2%
Total 2,021 100% 1,565 100% 270 100% 2 6 100% 3,882 100%

Patient may require medical intervention but lack of such would not result in permanent damage or impairment of a body function.

2

Patient requires in-patient hospitalization or prolongation of hospitalization directly attributable to the reaction; or the adverse reaction results in persistent/significant disability or incapacity; or it necessities medical/surgical intervention to preclude permanent/significant damage or impairment of a body function.

3

Patient may require major intervention following the transfusion (vasopressors, intubation, transfer to intensive care).

4

The consequences of the transfusion reaction are not certain.

N.B.
The total in Table 3A does not match that of Table 1A because of missing severity information for 75 cases.

More than 52.1% (n = 2,021) of the adverse transfusion reactions reported to the TTISS were of low severity i.e. they caused no permanent damage or impairment of a body condition (Table 3A). The remaining 47.9% sustained either a life-threatening condition (n = 270) or a condition serious enough to require hospitalization or prolonged hospitalization, medical/surgical intervention (n = 1,565). Over 92% (n = 249) of those that developed life-threatening conditions were transfused with blood components (Table 3B).

Table 3B. Severity of adverse reactions that resulted from transfusion of blood components, TTISS 2006-2012
Type of transfusion-related adverse reaction Grade 1
(Non-severe)
Grade 2
(Severe)
Grade 3
(Life-threatening)
Not determined Total
Freq. % Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload - TACO 578 43.2% 545 43.4% 91 36.5% 4 23.5% 1,218 42.6%
Acute hemolytic reaction 48 3.6% 46 3.7% 13 5.2% 2 11.8% 10 9 3.8%
Severe allergic anaphylactic/anaphylactoid reaction 87 6.5% 279 22.2% 33 13.3% 0 0.0% 399 14.0%
Hypotensive reaction 180 13.5% 90 7.2% 17 6.8% 0 0.0% 287 10.0%
Delayed hemolytic reaction 152 11.4% 46 3.7% 3 1.2% 6 35.3% 207 7.2%
Transfusion-related acute lung injury - TRALI 6 0.4% 40 3.2% 31 12.4% 1 5.9% 7 8 2.7%
Possible TRALI 3 0.2% 36 2.9% 22 8.8% 0 0.0% 61 2.1%
Transfusion-associated dyspnea – TAD 76 5.7% 48 3.8% 10 4.0% 0 0.0% 134 4.7%
Incompatible transfusion 28 2.1% 18 1.4% 3 1.2% 2 11.8% 51 1.8%
Bacterial infection 11 0.8% 16 1.3% 5 2.0% 1 5.9% 33 1.2%
Other 100 7.5% 74 5.9% 15 6.0% 1 5.9% 190 6.6%
Unusual reactions 69 5.2% 18 1.4% 6 2.4% 0 0.0% 93 3.3%
Total 1,338 100% 1,256 100% 249 100% 17 100% 2,860 100%
Table 3C. Severity of adverse reactions that resulted from transfusion of blood products (plasma derivatives), TTISS 2006-2012
Type of transfusion-related adverse reaction Grade 1
(Non-severe)
Grade 2
(Severe)
Grade 3
(Life-threatening)
Not determined Total
Freq. % Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 26 3.8% 20 6.5% 3 14.3% 0 0.0% 49 4.8%
Acute hemolytic reaction 41 6.0% 37 12.0% 1 4.8% 1 11.1% 80 7.8%
Severe allergic anaphylactic/anaphylactoid reaction 23 3.4% 53 17.2% 6 28.6% 1 11.1% 83 8.1%
Hypotensive reaction 29 4.2% 8 2.6% 0 0.0% 0 0.0% 37 3.6%
Delayed hemolytic reaction 100 14.6% 70 22.7% 2 9.5% 3 33.3% 175 17.1%
Transfusion-related acute lung injury – TRALI 0 0.0% 1 0.3% 1 4.8% 0 0.0% 2 0.2%
Possible TRALI 0 0.0% 0 0.0% 1 4.8% 0 0.0% 1 0.1%
Transfusion-associated dyspnea – TAD 10 1.5% 5 1.6% 1 4.8% 0 0.0% 16 1.6%
IVIG headache 259 37.9% 34 11.0% 0 0.0% 1 11.1% 294 28.8%
Aseptic meningitis 9 1.3% 27 8.8% 1 4.8% 1 11.1% 38 3.7%
Incompatible transfusion 1 0.1% 2 0.6% 0 0.0% 0 0.0% 3 0.3%
Other 163 23.9% 43 14.0% 5 23.8% 2 22.2% 213 20.9%
Unusual reactions 22 3.2% 8 2.6% 0 0.0% 0 0.0% 30 2.9%
Total 683 100% 308 100% 21 100% 9 100% 1,021 100%
N.B.
The total from Tables 3B and 3C do not add up to the overall total in Table 3A because of missing information on the type of blood product that was administered to one patient.
Table 4. Total units of blood components transfused by hospitals of the TTISS network from 2006 to 2012
Province/Territory 2006 2007 2008 2009 2010 2011 2012
Freq. % Freq. % Freq. % Freq. % Freq. % Freq. % Freq. %
Alberta 0 0% 10,091 1% 62,895 5% 68,561 6% 71,978 7% 114,734 10% 155,120 12%
British Columbia 181,391 17% 176,588 15% 172,415 14% 173,993 15% 172,696 16% 177,387 15% 177,299 14%
Manitoba 58,676 5% 57,578 5% 60,955 5% 52,525 5% 55,317 5% 54,819 5% 59,893 5%
New Brunswick 33,877 3% 35,144 3% 34,677 3% 29,973 3% 31,242 3% 29,276 2% 32,597 3%
Newfoundland & Labrador 22,485 2% 24,135 2% 23,610 2% 20,556 2% 23,549 2% 23,464 2% 23,856 2%
Nova Scotia 48,331 4% 49,019 4% 34,830 3% 39,965 4% 40,646 4% 42,893 4% 43,205 3%
Northwest Territories 394 0.0% 519 0.0% 560 0.0% 440 0.0% 393 0.0% 348 0.0% 505 0.0%
Ontario 337,340 31% 459,889 38% 390,350 33% 351,611 31% 349,176 32% 378,422 32% 365,591 29%
Prince Edward Island 4,871 0.4% 5,152 0.4% 4,775 0.4% 4,736 0.4% 4,430 0.4% 4,607 0.4% 4,400 0.0%
Québec 348,364 32% 345,910 28% 352,424 30% 338,005 30% 304,220 27% 310,047 26% 346,565 28%
Saskatchewan 47,647 4% 52,030 4% 53,154 4% 56,082 5% 51,700 5% 48,182 4% 46,707 4%
Yukon Territory 553 0.1% 448 0.0% 654 0.1% 590 0.1% 551 0.0% 499 0.0% 422 0.0%
Total 1,083,929 100% 1,216,503 100% 1,191,299 100% 1,137,037 100% 1,105,898 100% 1,184,678 100% 1,256,160 100%

From 2006 to 2012, the volume of blood components transfused in the TTISS network has remained virtually the same (Table 4). Larger proportions were transfused in larger jurisdictions like Québec and Ontario (Table 4).

Table 5. Overall risk of adverse reactions related to transfusion of blood components in the TTISS network for the period of 2006-2012
Type of transfusion-related adverse reaction Overall Risk
Frequency Per 100,000
units transfused
1 case per X
units transfused
Transfusion-associated circulatory overload – TACO 1,242 15.2 1 : 6,583
Acute hemolytic reaction 109 1.3 1 : 75,014
Severe allergic anaphylactic/anaphylactoid reaction 411 5.0 1 : 19,894
Hypotensive reaction 298 3.6 1 : 27,438
Delayed hemolytic reaction 211 2.6 1 : 38,751
Transfusion–related acute lung injury – TRALI 79 1.0 1 : 103,500
Possible TRALI 62 0.8 1 : 131,879
Transfusion–associated dyspnea – TAD 134 1.6 1 : 61,019
Incompatible transfusion 51 0.6 1 : 160,324
Bacterial infection 33 0.4 1 : 247,773
Other 193 2.4 1 : 42,365
Unusual reactions 97 1.2 1 : 84,294
Total 2,920 35.7 1 : 2,800
N.B.

The overall risk is calculated by dividing the number of adverse reactions from blood components by the total number of units of blood components transfused by hospitals participating in the TTISS from 2006 to 2012 (available in Table 1). The results are given per 100,000 units of blood components transfused and per the number of units to transfuse before a case can occur (Tables 5 & 6, and Figure 1).

Overall, the most common adverse transfusion reaction was transfusion-associated circulatory overload (TACO) which in general occurs once every 6,583 units of blood components transfused (Table 5). The least common was bacterial infection with just 33 cases in seven years (Table 5), corresponding to a risk of one case for every 247,773 units of blood components transfused. The corresponding annual risks (Table 6 & Figure 1) mirrored the general picture painted in Table 5.

Table 6. Annual rate of adverse reactions related to transfusion of blood components, TTISS 2006-2012
Type of transfusion-related adverse reaction 2006 2007 2008 2009 2010 2011 2012
Per 100,000 ut Table 6 - Footnote 1 1 case per X ut Per 100,000 ut 1 case per X ut Per 100,000 ut 1 case per X ut Per 100,000 ut 1 case per X ut Per 100,000 ut 1 case per X ut Per 100,000 ut 1 case per X ut Per 100,000 ut 1 case per X ut
1 ut
= units transfused
Transfusion-associated circulatory overload – TACO 15.0 1 : 6,650 12.7 1 : 7,899 14.5 1 : 6,886 12.5 1 : 8,007 16.7 1 : 5,978 18.2 1 : 5,485 16.6 1 : 6010
Acute hemolytic reaction 2.0 1 : 49,270 0.6 1 : 173,786 1.7 1 : 59,565 1.2 1 : 81,217 1.4 1 : 69,119 1.3 1 : 78,979 1.2 1 : 83,744
Severe allergic Anaphylactic /anaphylactoid reaction 5.2 1 : 19,356 4.4 1 : 22,528 4.8 1 : 20,900 4.4 1 : 22,741 7.1 1 : 13,999 4.2 1 : 23,694 5.2 1 : 19,326
Hypotensive reaction 4.0 1 : 25,208 3.5 1 : 28,291 3.9 1 : 25,898 3.0 1 : 33,442 3.6 1 : 27,647 2.5 1 : 39,489 4.9 1 : 20,261
Delayed hemolytic reaction 1.6 1 : 63,761 1.3 1 : 76,031 2.9 1 : 35,038 3.3 1 : 29,922 2.8 1 : 35,674 3.1 1 : 32,018 3.0 1 : 33,057
Transfusion-related acute lung injury – TRALI 1.7 1 : 60,218 1.4 1 : 71,559 0.6 1 : 170,186 0.8 1 : 126,337 0.7 1 : 138,237 1.0 1 : 98,723 0.6 1 : 157,020
Possible TRALI 0.4 1 : 270,982 0.1 1:1,216,503 1.2 1 : 85,093 0.8 1 : 126,337 1.2 1 : 85,069 0.7 1 : 148,085 1.0 1 : 96,628
Transfusion-associated dyspnea – TAD 1.4 1 : 72,262 0.6 1 : 173,786 1.9 1 : 51,796 1.4 1 : 71,065 3.2 1 : 31,597 1.5 1 : 65,815 1.6 1 : 62,808
Incompatible transfusion 0.3 1 : 361,310 0.4 1 : 243,301 1.0 1 : 99,275 0.6 1 : 162,434 0.5 1 : 184,316 0.7 1 : 148,085 0.8 1 : 125,616
Bacterial infection 0.3 1 : 361,310 0.2 1 : 608,252 0.4 1 : 238,260 0.4 1 : 284,259 0.6 1 : 157,985 0.8 1 : 131,631 0.2 1 : 418,720
Other 3.6 1 : 27,793 2.7 1 : 36,864 1.5 1 : 66,183 0.6 1 : 162,434 1.9 1 : 52,662 3.3 1 : 30,376 2.9 1 : 34,893
Unusual reactions 1.8 1 : 54,196 0.8 1 : 121,650 1.0 1 : 99,275 0.8 1 : 126,337 1.2 1 : 85,069 0.7 1 : 148,085 2.0 1 : 50,246
Total 37.2 1 : 2,690 28.7 1 : 3,486 35.3 1 : 2,830 29.8 1 : 3,354 41.1 1 : 2,436 38.0 1 : 2,633 40.1 1 : 2,492

Figure 1. Annual rate of adverse reactions related to transfusion of blood components, TTISS 2006-2012 (per 100,000 units of blood components transfused)

Figure 1
Text Equivalent - Figure 1

From 2006 to 2012, TACO was the most frequently reported adverse transfusion reaction which occurred at a rate of about 13 to 18 cases per every 100,000 units of blood components transfused per year (Figure 1). None of the other reported adverse transfusion reactions occurred at a rate equaled to 8 or more cases per 100,000 units transfused. Bacterial infections were the least common with about 2 to 8 cases per one million units transfused (Figure 1).


Table 7A. Outcome of reported adverse transfusion reactions, TTISS, 2006-2012
Type of transfusion-related adverse reaction Minor
sequelae Table 7a - Footnote 1
Major
sequelae Table 7a - Footnote 2
Death Not
determined Table 7a - Footnote 3
Total
Freq. % Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 1,191 33.1% 21 19.6% 22 37.9% 60 34.1% 1,294 32.9%
Acute hemolytic reaction 156 4.3% 14 13.1% 5 8.6% 15 8.5% 190 4.8%
Severe allergic anaphylactic/anaphylactoid reaction 463 12.9% 11 10.3% 1 1.7% 18 10.2% 493 12.5%
Hypotensive reaction 319 8.9% 4 3.7% 1 1.7% 10 5.7% 334 8.5%
Delayed hemolytic reaction 333 9.3% 30 28.0% 2 3.4% 19 10.8% 384 9.7%
Transfusion-related acute lung injury - TRALI 68 1.9% 3 2.8% 5 8.6% 5 2.8% 81 2.1%
Possible TRALI 33 0.9% 7 6.5% 13 22.4% 9 5.1% 62 1.6%
Transfusion-associated dyspnea – TAD 138 3.8% 5 4.7% 2 3.4% 4 2.3% 149 3.8%
IVIG headache 292 8.1% 0 0.0% 0 0.0% 3 1.7% 295 7.5%
Aseptic meningitis 36 1.0% 2 1.9% 0 0.0% 1 0.6% 39 1.0%
Incompatible transfusion 49 1.4% 0 0.0% 1 1.7% 4 2.3% 54 1.4%
Bacterial infection 25 0.7% 0 0.0% 2 3.4% 5 2.8% 32 0.8%
Other 383 10.6% 6 5.6% 4 6.9% 14 8.0% 407 10.3%
Unusual reactions 112 3.1% 4 3.7% 0 0.0% 9 5.1% 125 3.2%
Total 3,598 100% 107 100% 58 100% 176 100% 3,939 100%

Patient had no sequelae or permanent disability from the reaction or developed antibodies to low/medium frequency antigens (< 95%).

2

Patient developed either an infection with persistent infectious agent (HIV, Hepatitis C or B), or a transfusion reaction with major or long-term sequelae or the anticipation of difficulties with future transfusions (e.g. development of antibodies to antigens present in more than 95% of donations).

3

The outcome of the adverse reaction is not certain.

Less than 3% (n = 107) of the cases with outcome information developed either a serious infection or a transfusion reaction with major /long-term sequelae (Table 7A). In total 58 cases of death were recorded in the network during the 2006-2012 surveillance period of which 56 were patients that received blood components (Table 7B).

Table 7B. Outcome of adverse reactions that resulted from transfusion of blood components, TTISS 2006-2012
Type of transfusion-related adverse reaction Minor sequelae Major sequelae Death Not determined Total
Freq. % Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 1,136 43.5% 21 22.6% 21 37.5% 60 40.5% 1,238 42.6%
Acute hemolytic reaction 80 3.1% 13 14.0% 5 8.9% 11 7.4% 109 3.7%
Severe allergic anaphylactic/anaphylactoid reaction 383 14.7% 9 9.7% 1 1.8% 16 10.8% 409 14.1%
Hypotensive reaction 283 10.8% 4 4.3% 1 1.8% 8 5.4% 296 10.2%
Delayed hemolytic reaction 171 6.6% 26 28.0% 2 3.6% 11 7.4% 210 7.2%
Transfusion-related acute lung injury - TRALI 67 2.6% 3 3.2% 5 8.9% 4 2.7% 79 2.7%
Possible TRALI 32 1.2% 7 7.5% 13 23.2% 9 6.1% 61 2.1%
Transfusion-associated dyspnea - TAD 123 4.7% 4 4.3% 2 3.6% 4 2.7% 133 4.6%
Incompatible transfusion 46 1.8% 0 0.0% 1 1.8% 4 2.7% 51 1.8%
Bacterial infection 25 1.0% 0 0.0% 2 3.6% 5 3.4% 32 1.1%
Other 180 6.9% 2 2.2% 3 5.4% 8 5.4% 193 6.6%
Unusual reactions 84 3.2% 4 4.3% 0 0.0% 8 5.4% 96 3.3%
Total 2,610 100% 93 100% 56 100% 148 100% 2,907 100%

Table 7C. Outcome of adverse reactions that resulted from transfusion of blood products (plasma derivatives), TTISS 2006- 2012
Type of transfusion-related adverse reaction Minor sequelae Major sequelae Death Not determined Total
Freq. % Freq. % Freq. % Freq. % Freq. %
Transfusion-associated circulatory overload – TACO 55 5.6% 0 0.0% 1 50.0% 0 0.0% 56 5.4%
Acute hemolytic reaction 76 7.7% 1 7.1% 0 0.0% 4 14.3% 81 7.9%
Severe allergic anaphylactic/anaphylactoid reaction 80 8.1% 2 14.3% 0 0.0% 2 7.1% 84 8.1%
Hypotensive reaction 35 3.5% 0 0.0% 0 0.0% 2 7.1% 37 3.6%
Delayed hemolytic reaction 162 16.4% 4 28.6% 0 0.0% 8 28.6% 174 16.9%
Transfusion-related acute lung injury – TRALI 1 0.1% 0 0.0% 0 0.0% 1 3.6% 2 0.2%
Possible TRALI 1 0.1% 0 0.0% 0 0.0% 0 0.0% 1 0.1%
Transfusion-associated dyspnea – TAD 15 1.5% 1 7.1% 0 0.0% 0 0.0% 16 1.6%
IVIG headache 292 29.6% 0 0.0% 0 0.0% 3 10.7% 295 28.6%
Aseptic meningitis 36 3.6% 2 14.3% 0 0.0% 1 3.6% 39 3.8%
Incompatible transfusion 3 0.3% 0 0.0% 0 0.0% 0 0.0% 3 0.3%
Other 203 20.6% 4 28.6% 1 50.0% 6 21.4% 214 20.8%
Unusual reactions 28 2.8% 0 0.0% 0 0.0% 1 3.6% 29 2.8%
Total 987 100% 14 100% 2 100% 28 100% 1,031 100%
N.B.

The total from Tables 7B and 7C do not add up to the overall total in Table 7A because of missing information on the type of blood product that was administered to one patient.

Of the 1,031 cases derived from transfusion of blood products, two (0.2%) died and 14 (1.4%) sustained major or long-term sequelae (Table 7C) from delayed hemolytic reactions (n = 4), aseptic meningitis (n = 2), severe anaphylactic/anaphylactoid reaction (n = 2) transfusion-associated dyspnea (n = 1), acute hemolytic reaction (n = 1), and other adverse transfusion reactions (n = 4) that could not be categorized (Table 7C).

Table 8. Strength of the relationship (Imputability) between adverse transfusion reaction and death, TTISS 2006 - 2012
Transfusion-related death Definite Table 8 - Footnote 1 Probable Table 8 - Footnote 2 Possible Table 8 - Footnote 3 Doubtful Table 8 - Footnote 4 Ruled
out Table 8 - Footnote 5
Total
The patient's death occurred within a time frame consistent with the administration of the blood, blood component, or blood product (plasma derivative) and was proven by investigation to have been caused by transfusion.
2The patient's death occurred within a time frame consistent with the administration of the blood, blood component, or blood product (plasma derivative) and did not seem to be explainable by any other cause.
3The patient's death occurred within a time frame consistent with the administration of the blood, blood component, or blood product (plasma derivative) but could be explained by concurrent disease(s) or by the administration of a drug or other agent.
4The patient's death occurred within a reasonable time frame in relation to the transfusion but the preponderance of data supports an alternative explanation.
5TThe patient's death occurred within a time frame inconsistent with the administration of the blood, blood component, or blood product (plasma derivative) or if it occurred within a consistent time period but was proven by investigation to have no relationship to the transfusion.
Transfusion-associated circulatory overload - TACO 0 4 9 5 4 22
Acute hemolytic reaction 0 0 4 0 1 5
Severe allergic anaphylactic /anaphylactoid reaction 0 0 0 0 1 1
Hypotensive reaction 0 1 0 0 0 1
Delayed hemolytic reaction 0 0 0 1 1 2
Transfusion-related acute lung injury - TRALI 1 1 3 0 0 5
Possible TRALI 0 3 8 2 0 13
Transfusion-associated dyspnea - TAD 0 1 0 1 0 2
Incompatible transfusions 0 0 0 0 1 1
Bacterial infection 0 1 1 0 0 2
Other 0 1 3 0 0 4
Total 1 12 28 9 8 58

Over the 2006-2012 period, only one case of death (Table 8) was definitely deemed to be associated with transfusion. Other cases were reported to be either probably (n=12) or possibly (n=28) related to transfusion. The relationship between transfusion and death was either ruled out or doubtful at best in the other 20 cases (Table 8). Little over 95% (n = 39) of transfusion-related deaths were recipients of blood components. The other two cases received respectively Intravenous immunoglobulin (IVIG) and Factor VIIa. With a total of 8,176,504 units transfused by the TTISS network between 2006 and 2012, the overall risk of dying from transfusion of blood components amounted to 1 per every 209,654 units transfused.

Table 9. Trend of transfusion-related deaths in the TTISS network from 2006 to 2012
Transfusion-related death Table 9 - Footnote 1 2006 2007 2008 2009 2010 2011 2012 Total
Transfusion-related deaths include deaths definitely, probably or possibly linked to transfusion.
Transfusion-associated circulatory overload  - TACO 2 1 4 1 1 2 2 13
Transfusion-related acute lung injury - TRALI 2 0 0 0 1 1 1 5
Possible TRALI 2 0 1 2 2 2 2 11
Acute hemolytic reaction 1 1 2 0 0 0 0 4
Transfusion-associated dyspnea – TAD 0 0 0 0 1 0 0 1
Bacterial infection 0 0 1 0 0 1 0 2
Hypotensive reaction 1 0 0 0 0 0 0 1
Other 0 1 1 1 0 0 1 4
Total 8 3 9 4 5 6 6 41

The highest number of transfusion-related deaths was recorded in 2006 (n = 8) and 2008 (n = 9) and the lowest was in 2007 (n = 3). With the exception of TACO in 2008, no adverse reaction was associated with more than 2 deaths per year (Table 9) over the entire 2006-2012 surveillance period.

Figure 2: Number of transfusion-related deaths (n=41), TTISS 2006 - 2012

Text Equivalent - Figure 2

Overall, the leading causes of transfusion-related death Figure 2 - Footnote 1 were TRALI (including possible TRALI) and TACO (Figure 2) as they accounted respestively for 71% of the cases (Table 9 and Figure 2).

1
Transfusion-related deaths include deaths definitely, probably or possibly linked to transfusion.
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