AUTOLOGOUS (pre-operative),
DIRECTED & DESIGNATED
DONATIONS
Blood Centre Perspective
Transfusion Medicine Resident Topic Teaching
October 11, 2011
D.K. Towns, MD, FRCPC (Anesthesia)
Medical Director - Calgary
Canadian Blood Services
dale.towns@blood.ca
Autologous Donation
Autologous donor: an individual who donates blood for
the purpose of transfusion back to him/herself at a later
time. At Canadian Blood Services, autologous donors must
meet Donor Selection Acceptance Criteria, modified from
the Whole Blood Programme for allogeneic donors.
• This is most commonly requested in preparation for upcoming,
scheduled elective surgery
• Consent is required
• No age limits
• Must be requested by a physician (usually the surgeon, or, the
family physician)
• If outside of CBS criteria, may consider collection at the hospital
2
Autologous Donation (con’t)
• Minimum weight of 55 lb
- If less than 110 lb, a formula-driven reduced collection is performed
• Minimum hemoglobin/hematocrit at first donation: 110 g/l/.33
- Subsequent donations: 105/.32
• Red cell shelf life is 42 days
- Therefore, usually a maximum of 4 units, 1 week apart, and no more
than 72 hours prior to surgery
• Consider oral iron replacement
- ?erythropoietin
• Collected in CPD with added SAGM
- Red blood cells and plasma produced
- Plasma discarded unless specifically requested - then issued as FP
• Whole blood no longer available
3
Indications
• Consider only if the chance of requiring a transfusion is > 10%
• How many and when to collect?
• The same number as would be ordered for an allogeneic
crossmatch using M-BOS (or a case-by-case assessment)
• Common surgical indications:
–
–
–
–
–
major vascular surgery, including cardiac
radical prostatectomy
major orthopedic, including hip and knee (particularly re-do), scoliosis
liver resection
“at risk” obstetrics
4
• Many Canadian hospitals have autologous
donation programs
• Patients deemed high risk at Canadian
Blood Services may be considered for inhospital donation
• PAD programs are available at most
Canadian Blood Services permanent
donor clinics
5
Acceptance criteria differs from allogeneic donation
(hemoglobin, hematocrit, collection intervals)
– The donor questionnaire is significantly abbreviated,
focusing primarily on risks of the donation process to
the donor or risks of bacterial contamination
Other areas differing from allogeneic donation:
• Can donate if:
–
–
–
–
–
received blood/blood products recently
cancer
some cardiac conditions
recent invasive procedures (example, tattoos, piercings)
medication use (which does not increase risk to the donation
process)
– pregnancy
– syphilis positive
6
Contraindications
•
•
•
•
•
•
•
•
•
•
•
Evidence of infection/risk of bacteremia
IHSS (idiopathic hypertrophic subaortic stenosis)
Aortic stenosis
Left main coronary artery disease
Unstable angina
Cardiac failure
MI in previous 6 weeks
A-V block
Uncontrolled hypertension
Cyanotic heart disease
Active seizure disorder
7
• Each unit in every series is tested for the same infectious disease
markers as for allogeneic donations
• TD positive units (except for syphilis) must be discarded
• TD markers repeat reactive for infectious diseases but confirmatory
negative or indeterminate can be released but have a biohazard
label
• Anti-HBcore positive units with or without a positive anti-HBs can be
similarly released
Note:
Hospital-collected autologous units "should be" tested for
transmissible diseases, but if positive - do not have to be
discarded; a policy shall simply be in place as to how to deal
with them
8
Advantages
• Major impetus - particularly in the past - was patient and physician
desire to eliminate the risk of transfusion-transmitted viral diseases
(particularly HIV and Hepatitis)
• Autologous transfusion minimizes exposure to allogeneic red cells
and leukocyte antigens which could lead to future transfusion
compatibility difficulties
• There is some evidence that allogeneic transfusion can lead to
modulation of the recipients immune system
• Autologous donation theoretically can enhance the available
allogeneic supply
• Provides compatible blood for patients with alloantibodies/rare blood
• Decreases risk of some adverse transfusion reactions (febrile
reactions, TRALI reactions, allergic reactions, delayed hemolytic
reactions)
9
Disadvantages
• Higher costs
– Logistic issues
- The blood must be at the right place in the right condition at the right
time
- Must be specially labelled
- Must be a system in place at both the hospital and blood centre
- The hospital blood bank must know the blood is available, and how
many units are available, so that autologous blood is used before
allogeneic
• High wastage (approximately 50%)
• Surgical delay may result in outdating and discard of units
• Units cannot be crossed over into the allogeneic pool (differing
acceptance criteria)
• Subjects patients to perioperative anemia, in general.
10
Risks which are NOT decreased
• Bacterial contamination
• Risk of driving to and from donation
• Clerical error leading to wrong unit being transfused
(1:50,000)
• Receiving allogeneic blood before, or instead of autologous
blood
• Autologous donors have approximately 12x higher risk of
reaction than allogeneic donors at the time of donation.
(Usually in young patients, underweight, previous reaction, or
first time donation.)
**Never transfuse autologous blood simply because it’s there
11
Autologous Donations 1999 to 2010, Canadian Blood Services
4,000
Number of Autologous Donations
3,500
3,000
2,500
2,000
1,500
1,000
500
0
BC AND
YUKON
CALGARY
EDMONTON
HALIFAX
HAMILTON
LONDON
NEW
BRUNSWICK
NEWFOUNDLA
ND AND
OTTAWA
REGINA
LABRADOR
SASKATCHE
WAN
SUDBURY
TORONTO
WINNIPEG
1999
375
182
108
82
1,977
396
16
75
2,678
50
103
240
1,396
321
2000
783
292
304
156
3,475
1,266
29
112
2,478
72
188
261
1,988
633
2001
556
283
308
87
3,159
1,402
27
55
1,998
65
173
198
1,677
579
2002
523
198
161
89
2,904
1,298
28
44
1,529
55
171
182
1,453
391
2003
389
630
178
53
2,520
1,082
30
50
1,442
0
236
175
1,520
470
2004
457
844
133
90
2,090
1,005
13
55
1,193
0
200
79
1,459
247
2005
297
599
92
67
1,706
805
24
29
1,112
0
231
82
1,498
237
2006
115
388
57
57
1,669
813
16
23
923
0
236
52
1,356
173
2007
62
340
81
49
1,322
599
28
19
702
0
201
45
916
167
2008
50
135
48
43
842
527
14
6
406
0
139
30
706
110
2009
60
85
24
10
535
437
11
13
268
0
158
26
549
61
2010
18
44
37
14
344
399
17
9
230
0
128
17
407
63
12
Autologous Donations
by Fiscal Period
15,000
11,104
11,505
Numebr of Donations
10,224
10,000
8,933
8,497
7,589
6,456
5,566
5,000
4,155
2,831
2,140
1,500
0
1999/00
2000/01
2001/02
13
2002/03
2003/04
2004/05
2005/06
2006/07
2007/08
2008/09
2009/10
2010/11
Krever Recommendations – Interim Report
Using The Patient’s Own Blood (articles 18-25)
18. The programs for autologous blood be made available
throughout Canada to patients who are scheduled for
elective surgery
22. That Departments of Public Health determine in which
public hospitals it would be feasible to create
autologous programs
23. That programs be ‘inclusive’
24. That hospitals, surgeons, physicians inform patients of
the existence of autologous programs
25. That written information be provided well in advance of
elective surgery
14
Krever Recommendations – Interim Report
Recommendations to the Blood Service
The blood service should:
19. Examine ways in which it can extend its PAD to a
greater number of patients over a wider geographic
area
20. Ensure that its PAD Program is available to patients
about to undergo surgery outside their province of
residence
21. Take active measures to publicize its PAD service
15
The Cochrane database of Systematic Reviews
Volume 2, 2002
• Pre-operative autologous donation reduced the risk of
receiving allogeneic blood transfusion by a relative 63%
• The risk of receiving any blood transfusion was 43.8%.
Billote, et al. J Bone Joint Surg 2002
• prospective randomized controlled trial:
–
–
–
–
–
patients undergoing total hip arthroplasty - hemoglobin ≥ 120 g/L
half donated autologous blood, half did not
*pre-determined transfusion trigger was defined
neither received allogeneic blood
of the autologous donors, 69% received an autologous
transfusion
– 41% of the autologous units were wasted
16
Vamvakas in 2002 and 2007 (Vox Sang)
• critical reappraisal of clinical trials on the
immunomodulatory effect of allogeneic blood
transfusion
• did not unequivocally identify an association
between allogeneic erythrocyte concentrate
transfusion and postoperative infection, or short
term mortality
17
Utilization
• CBS data
• Calgary-specific data
• Gail Rock (Transfusion Medicine, 2006; A
review of nearly two decades in an autologous
blood programme...)
• other ...
• All show < 50% utilization rates of autologous
blood
18
• Guidelines for policies on alternatives to
allogeneic blood transfusion. 1. PAD and
transfusion. Transfusion Medicine, 2007
• PAD not recommended unless the clinical
circumstances are exceptional
– rare blood groups
– children with scoliosis
– patients at serious psychiatric risk
– patients who refuse to consent to allogeneic
transfusion
19
Caspari - letter to the editor (Transfusion Medicine
2007)
• autologous donation may be indicated for patients with
rare blood groups and/or blood group antibodies
• for patients in highly developed countries - where
safety and supply is not an issue
– it is difficult to demonstrate a net benefit of autologous over
allogeneic blood transfusion
20
Case Study #1
• 63 year old female undergoing bilateral
mandibular osteotomy
• family physician takes responsibility for
ordering 2 units RBC
• donation takes place at CBS
• negative past history
• first unit anti-HCV positive
• *surgeon cancels surgery altogether
21
Case Study #2
• 45 year old male undergoing total hip arthroplasty
• 2 units RBC ordered
• 1st unit anti-HIV positive
a) donation takes place at CBS
- what do you do with the unit?
b) donation takes place at hospital
... and now?
• what are the issues?
22
Dedicated Donations:
1) Directed Donations
• an allogeneic donation where the patient who requires a
blood transfusion selects an individual or individuals
(usually friends or relatives) to provide the necessary
blood products (usually RBCs). For patients who are not
yet of legal age, the selection of the donor(s) is done by
the parents.
2) Designated
• donations selected from a specific donor for a specific
recipient, for medically indicated reasons.
23
24
• Directed Donations have been available in the U.S. (and
Europe, Australia . . .) for many years
• Until 1996, not permitted by the CRCS - BTS (unless
medically indicated, now termed "designated")
• In January 1996, Dr. Francine Décary convened an
advisory group of experts:
– concluded that DD should be made available but not
actively promoted
• At the same time, a court order obliged the CRCS in
Montreal to provide DD to a child undergoing heart
surgery from his two parents
25
• The CRCS program started soon after
• Héma-Québec - which now became the blood
operator in Quebec, also started a DD program
• CRCS (and now CBS) provided DD from parent
(biological or adoptive) to a minor aged child, as
does CBS currently
• Héma-Québec's program is open to any
compatible donor/recipient pair irrespective of
recipient age or donor and recipient relationship
26
• Dr. Goldman's 1998 article in the CSTM Bulletin
summarizes the first 2 years of Héma-Québec's
experience:
– it was a small program
– the utilization rates were poor
– it decreased donor exposure in only 20% of
recipients
27
CBS procedure:
• The transfusing physician must fill out a requisition after determining
the selected donor's blood is compatible with the recipient.
• If CMV seronegativity is required, this must be determined and
ensured by the physician prior to the request.
• The donor must fulfill the same criteria as an allogeneic donor (a few
exceptions)
• Bled into a "B-2" pack (capability to make RBC and FP)
– shelf life 42 days BUT will likely be irradiated, therefore 28 days
* Note, FP is only issued if specifically requested
* Note also, RBC may be compatible but FP might not
• last donation must be at least 72 hours prior to transfusion
28
What about safety?
• possibility of graft vs. host disease (risk
mitigated by appropriate gamma
irradiation)
• transmissible disease risk:
– Dr. Nadine Shehata analyzed CBS TD data:
• Directed Donors in Canada had slightly
higher rates of positivity for Hepatitis B, C,
and syphilis than regular allogeneic doors
29
Other risks:
• Same as allogeneic transfusion, but in addition:
– In newborn - maternal antibodies against paternally
inherited antigens (therefore don't use plasma;
TRALI risk reduction measures have since prevented
maternal plasma transfusion)
– In newborn - father's red cells may be incompatible
with maternally derived antibodies still present
– If any adverse event related to the blood transfusion
were to occur - ? guilt/blame
30
Case Presentation #1
– 8 year old child undergoing craniotomy and tumor
removal
– Mom is a family physician
– Dad is selected as compatible RBC donor
– 2 units requested
– First unit successfully donated
– 24 hours later, dad called with post donation
information . . .
• What are the issues?
• What would you do with this unit?
• What about the next planned donation?
31
Designated Donations:
Some of the medically indicated reasons for designated
donations include:
– patients with rare blood groups and antibodies
– infants with NAIT or HDN
– children with major blood loss surgery where designated donors may
decrease donor exposure
– children with anticipated lifelong transfusion requirements (thalassemia,
sickle cell anemia)
– patients with leukemia in relapse after bone marrow transplantation
– (donor leukocytes are used as adoptive immunotherapy to induce graft
versus leukemia)
– HLA – matched apheresis platelets
• Designated Donors may, or may not be known or selected by their
recipient
• They may be selected by the Blood Centre
• Crossover is acceptable if the donor has met all criteria for allogeneic
donation.
32
Case Presentation #2
• 48 year old male post bone marrow transplant for CML
• Bone marrow donor is identical twin (therefore identical
match) (*but has never donated blood)
• Post transplant:
– patient bleeding, first mucosal and bladder, finally GI tract
– platelet count 5
– random platelet transfusions from hospital blood bank fail to
produce increment
– Oncologist wants plateletpheresis product(s) from twin
– Wants to transfuse “urgently" prior to completion of testing
• What are the issues to consider?
33
Directed Donations
by Fiscal Period
1,500
Numebr of Donations
1,076
1,000
983
800
742
665
666
594
553
500
447
381
305
209
0
1999/00
2000/01
2001/02
34
2002/03
2003/04
2004/05
2005/06
2006/07
2007/08
2008/09
2009/10
2010/11
Directed Donations 1999 to 2010, Canadian Blood Services
450
Number of Directed Donations
400
350
300
250
200
150
100
50
0
BC AND
YUKON
CALGARY
EDMONTON
HALIFAX
HAMILTON
LONDON
NEW
BRUNSWICK
NEWFOUNDLA
ND AND
OTTAWA
REGINA
LABRADOR
SASKATCHE
WAN
SUDBURY
TORONTO
WINNIPEG
1999
46
38
5
21
49
23
11
0
215
21
10
16
204
1
2000
97
62
16
26
181
62
13
6
218
35
17
22
386
10
2001
62
78
10
22
135
20
7
8
115
29
5
18
330
13
2002
28
62
21
28
67
13
15
4
140
15
14
15
347
17
2003
15
43
10
21
90
30
8
8
92
0
19
19
286
7
2004
26
30
13
25
141
49
8
8
103
0
16
19
265
23
2005
15
22
14
20
110
26
9
4
93
0
21
20
233
4
2006
10
34
7
24
58
27
10
0
123
0
39
7
203
0
2007
9
23
6
13
99
34
7
1
69
0
12
7
187
1
2008
6
28
0
6
69
21
4
1
96
0
6
12
185
0
2009
1
7
0
11
54
9
3
1
81
0
22
21
106
3
2010
4
9
2
1
26
3
4
3
63
0
17
8
72
1
35