Transcript Blood Utilization in ECMO Patients

CBS Journal Club
Christopher Sharpe MD, FRCPC
R6 Transfusion Medicine
March 1, 2011
1
Objectives
• to discuss the impact of deferring female
plasma and platelet apheresis donors on
blood component availability in the US
• to discuss TRALI-mitigation strategies
(including the current CBS policy)
2
Focus of Journal Club
“ Blood donations from previously
transfused or pregnant donors: a
multicenter study to determine the
frequency of alloexposure ”
Rios JA, Schlumpf KS, Kakaiya RM, et al.
Transfusion 2011
Introduction
• transfusion-related acute lung injury
(TRALI) is a leading cause of death due to
blood transfusion
• US FDA data:
- 35% of deaths due to transfusion (2008)
- 30% of deaths due to transfusion (2009)
4
Introduction
• November 2006:
- TRALI mitigation strategies implemented
widely to minimize the preparation of highplasma volume components from donors
immunized (or at risk for immunization) against
white blood cell antigens
5
Introduction
• UK data (Chapman, Transfusion 2009)
- risk for highly likely or probable TRALI cases
was 15.5 cases per 1 million units of FFP issued
in 1999-2004 (when both male and female
plasma was transfused)
- risk for highly likely or probable TRALI cases
was 3.2 cases per 1 million units of FFP issued
in 2005-2006 (when male plasma was
transfused)
6
Introduction
• UK Data: SHOT Steering Committee 2010
- plasma for transfusion is manufactured
from males since late 2003
2002: 32 cases of TRALI
2009: 14 cases of TRALI
7
Introduction
• Remaining question:
- do other TRALI-mitigation steps need to
be considered aside from the complete
exclusion of all female donors from the
donor pool?
8
Introduction
• CBS policy:
- defer female donors from donating transfusable
plasma (unless AB plasma is required)
- use female plateletpheresis donors only if they
do not have a history of pregnancy
- female donor plasma used for fractionation
9
Specificities of leukocyte alloantibodies in transfusionrelated acute lung injury and results of leukocyte
antibody screening of blood donors
Reil et al., Vox Sang 2008
• Purpose:
- to determine the specificities of leukocyte antibodies
implicated in previous severe TRALI reactions
• Results:
- 36 TRALI cases reviewed
- anti-HLA class II (17 cases)
- anti-HNA (12 cases; 10 with anti-HNA-3a)
- anti-HLA class I (4 cases)
- anti-HLA class I/II (3 cases)
10
Specificities of leukocyte alloantibodies in transfusionrelated acute lung injury and results of leukocyte
antibody screening of blood donors
Reil et al., Vox Sang 2008
• Results:
- investigated 5332 parous female donors
- 473 had leukocyte antibodies
(8.9% alloimmunization rate)
- 61% had anti-HLA class I
- 19% had anti-HLA class II
- 12% had both anti-HLA class I and class II
- 5% had anti-HNA
11
Specificities of leukocyte alloantibodies in transfusionrelated acute lung injury and results of leukocyte
antibody screening of blood donors
Reil et al., Vox Sang 2008
• Results:
- no antibody-mediated TRALI cases were observed
following introduction of a policy of accepting
transfusable plasma only from male donors, nulliparous
female donors, or tested multiparous female donors
without HLA antibodies
- no shortage of plasma or platelet products was
encountered as a result of the restrictive strategy
12
Specificities of leukocyte alloantibodies in transfusionrelated acute lung injury and results of leukocyte
antibody screening of blood donors
Reil et al., Vox Sang 2008
• Conclusion:
- isolated HLA-class I antibody screening is
insufficient for leukocyte antibody
screening
13
Introduction
• the prevalence of human neutrophil
antibodies (HNA) antibodies among US
blood donors is small compared to the
number with HLA antibodies
(Triulzi, Transfusion, 2008)
14
Prevalence of HLA antibodies in remotely transfused or
alloexposed volunteer blood donors (LAPS-1)
Kakaiya et al., Transfusion 2010
• 7920 donors (2086 males, 5834 females) were
tested for antibodies against HLA class I and
HLA class II
• the prevalence of HLA class I and/or class II
antibodies was similar in nontransfused
(1138; 1.0%) vs. transfused men (895; 1.7%)
15
Identification of specificities of antibodies against
human leukocyte antigens in blood donors (LAPS-1)
Endres et al., Transfusion 2010
• antibody frequencies against HLA class I and
HLA class II were determined for 7920 donors
(2086 males, 5834 females) with a positive
antibody screen
• positive rate increased among women with 0 to
4 or more pregnancies (0.3-15.6% for anti-HLA
class I and 0.4-18% for anti-HLA class II;
p<0.00001)
16
The effect of previous pregnancy and transfusion on HLA
alloimmunization in blood donors: implications for a transfusionrelated acute lung injury risk reduction strategy
Triulzi et al., Transfusion 2009
• Purpose: to determine the prevalence of HLA antibodies
in blood donors and and their relationship to previous
transfusion or pregnancy
• Methods:
- 8171 volunteer blood donors were prospectively
recruited by six US blood centers from
December 2006 to May 2007
- donors provided a detailed history of prior pregnancies
and transfusion events
- donors were tested for HLA Class I and II antibodies
17
The effect of previous pregnancy and transfusion on HLA
alloimmunization in blood donors: implications for a transfusionrelated acute lung injury risk reduction strategy
Triulzi et al., Transfusion 2009
• Results:
- HLA antibodies were detected in 17.3% of all female
donors (n = 5834) and in 24.4% of those with a history of
previous pregnancy (n = 3992)
- the prevalence of HLA antibodies increased in women
with more pregnancies:
- 1.7% (no pregnancies)
- 11.2% (one pregnancy)
- 22.5% (two pregnancies)
- 27.5% (three pregnancies)
- 32.2% (four or more pregnancies; p < 0.0001)
18
Introduction
• Retrovirus Epidemiology Donor Study-II
(REDS-II)
- funded by NIH
- investigated the presence of antibodies to human
leukocyte antigens (HLA) and/or human neutrophil
antigens (HNA) among six US blood centers
19
Blood donations from previously transfused or pregnant donors:
a multicenter study to determine the frequency of alloexposure
Rios JA, Schlumpf KS, Kakaiya RM, et al.
Transfusion 2011
• Purpose:
- to estimate the prevalence of WBC alloimmunization
according to the pregnancy and transfusion history of
allogeneic blood donors at each of the REDS-II blood
centers
- to compare the impact of the implementation of the
aaBB TRALI mitigation strategies among six different
blood centers in the US
(only using male plasma for transfusion and deferring
female plateletpheresis donations)
20
Methods
• data used was from Retrovirus Epidemiology
Donor Study-II (REDS-II)
• Six participating blood centers in study:
- Blood Centers of the Pacific (San Francisco)
- American Red Cross Blood Services Southern Region
(Atlanta, GA)
- New England (Massachusetts)
- Hoxworth Blood Center (Cincinnati)
- Institute for Transfusion Medicine (Pittsburgh)
- BloodCenter of Wisconsin (Milwaukee)
21
Methods
• donation data was sent to the REDS-II central
coordinating center for compilation
• data collected from Jan 2006 – Dec 2008
- age
- sex
- first-time or repeat donor status
- transfusion history
- pregnancy history
- donation procedure (whole blood vs apheresis component)
- blood donation type (allogeneic vs. autologous donation)
- blood type
22
Methods
• the percentages of donations from donors with risk
factors for HLA and/or HNA alloimmunization were
calculated
• the number of donations of apheresis platelets from
female donors that could have HLA antibodies was
calculated
(according to prior pregnancy history from this study
AND the proportion of female donors with positive
screening test results for HLA antibodies from the
LAPS-I Study)
23
Methods
• the percentages of donations resulting in
1, 2, or 3 units of apheresis PLTs at two
REDS-II blood centers were used to calculate
the numbers of apheresis PLTs products that
could be lost if the following groups were
deferred from future apheresis PLT donations:
- all female donors
- all ever-pregnant female donors
- all ever-pregnant female donors with anti-HLA
24
Methods
• the percentages of donations from donors with AB blood
type were calculated from:
- all male donors
- all female donors
- all ever-pregnant female donors
- all ever-pregnant female donors with positive screening
tests for HLA antibodies
• chi-square test was performed to assess the association
between the percentage of female apheresis PLT donors
in 2006 compared to 2008
25
Table 1
26
Figure 1
27
Table 2
28
Figure 2
29
Table 3A
30
Table 3B
31
Table 4A
32
Table 4B
33
Table 5
34
Table 6
35
Discussion
• study provided data on the frequency of risk factors for
alloimmunization to WBC antigens among US blood
donors (transfusion and pregnancy history)
• study data allowed for an estimation of the loss of
available blood components using various TRALI
mitigation strategies:
- deferring all female donors would incur a 50% reduction
in the number of units of whole blood available for
transfusable plasma manufacturing
- deferring all female donors would incur a loss of 37% of
apheresis platelet donations
4
33
Discussion
• only 3-4% of blood donors between 2006 and 2008
reported a history of prior transfusion
• the prevalence of HLA antibodies among blood donors
appears independent of prior transfusions
- deferring donors with a transfusion history is not an
effective TRALI mitigation strategy
4
33
Discussion
• 66.7% of 95000 donations of apheresis platelets from
female donors were donated by women reporting a
history of one or more pregnancies
• TRALI mitigation strategies for female apheresis platelet
donors:
- defer all female donors (lose 37.1% of donors)
- defer female donors who have had at least one prior
pregnancy (lose 22.5% of donors)
- defer previously-pregnant females who have HLA
antibodies (lose 5.4% of donors)
4
33
Discussion
• Strategies to make up for the deferred units from
previously-pregnant female apheresis platelet donors
who have HLA antibodies (5.4%):
- increase the production of platelet concentrates from
whole blood
- replace with male donors
- replace with nulliparous female donors
- replace with ever-pregnant female donors without HLA
antibodies
• the institution of HLA antibody measurement in this
setting is problematic
4
33
Critical Appraisal
• Are the results valid?
• yes:
- information on what impact various TRALI mitigation
strategies would have on the availability of blood
components is needed
- the volume of donor data available for analysis in this
study is large (but it represents only ~8% of total
donations made in the United States)
4
33
Critical Appraisal
• Are the results valid?
- the methodology used to measure HLA and HNA
antibodies in the REDS-II study was not stated in the
current study
- bias in information collection is likely not an issue in this
study since donors volunteered relatively simple
demographic information (gender, pregnancy and
transfusion history)
- missing data on previous pregnancies was an issue in
only a small number of donors (~ 3%)
4
33
Critical Appraisal
• Are the results valid?
- it appears safe to assume that females that have
not been previously-pregnant will not have HLA
antibodies
- is it safe to accept that prior transfusion is not a
significant risk factor for WBC alloimmunization?
4
33
Critical Appraisal
• Are the results valid?
- not every country or jurisdiction may possess the
capacity to measure HLA or HNA antibodies in their donor
population
- plateletpheresis units are not usually split into multiple
units in Canada
- double-RBC collections are not usual in Canada (yet)
4
33
Critical Appraisal
• What are the results?
In the Unites States:
- deferral of all female apheresis PLT donors: 37.1% loss
of total donations
- deferral of all female apheresis PLT donors with a prior
pregnancy history: 22.5% loss of total donations
- deferral of all female apheresis PLT donors with a prior
pregnancy history and positive screening results for HLA
antibodies: 5.4% loss of total donations
4
33
How Can I Apply The Results To
Patient Care?
• Current CBS policy:
- defer female donors from donating transfusable
plasma (unless AB plasma is required)
- female donor plasma used for fractionation
- use female plateletpheresis donors only if they
do not have a history of pregnancy
45
TRALI Cases Reported to CBS 2001-2009
• PMP (predominantly male plasma) used for
transfusion October 2007
Year
2001
2002 2003 2004 2005
Definite/
Possible
TRALI
6
6
6
2006
2007
2008
2009
16 14 21 36 19 12
46
TRALI Cases Reported to CBS 2001-2009
• component breakdown for definite/possible
TRALI cases
Year
Total
RBC
PLT
Plasma Mixed
2007
36
18
3
7
8
2008
19
11
3
2
3
2009
12
7
1
1
3
47
CBS Data
48
CBS Data
49
CBS Data
50
CBS Data
51
CBS Data
52
CBS Data
53
CBS Data
54
Questions or
comments?
16