Transcript Original Presentation - Transfusion Medicine

TOPIC TEACHING:
DEDICATED (Directed and Designated) &
(Pre-operative) AUTOLOGOUS
DONATIONS
Dr. Dale Towns, MD, FRCPC, Anes.
Medical Director,
Canadian Blood Services
Calgary
Friday September
12, 2008
1
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.
2
AUTOLOGOUS DONATIONS:
• Donation of blood by a patient for his/her
own future use, most commonly prior to
scheduled elective surgery.
3
DIRECTED DONATIONS:
Donated by relatives or friends who are specifically chosen by
the recipient (or parents)
Advantages:
• may decrease total donor exposure if appropriately indicated
and planned
• may decrease anxiety in the recipient or parents who have
fears about the safety of the blood supply
Disadvantages:
• contravenes the normal principles of voluntary blood
donations
• loss of donor anonymity
• donor may be less than candid to sensitive donor questions
• fails to increase safety
4
• 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
5
• 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
6
• 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
7
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
8
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
9
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
10
Directed Donations
by Fiscal Period
1,500
1,076
1,000
983
800
742
665
666
594
553
500
447
0
1999/00
2000/01
11
2001/02
2002/03
2003/04
2004/05
2005/06
2006/07
2007/08
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?
12
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.
13
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?
14
AUTOLOGOUS DONATIONS
15
• PAD programs are available at most CBS permanent donor clinics
for elective surgery in otherwise health donors
• criteria not as stringent as for allogeneic donations
• ensure that it is safe for donor to participate in the donation process
• contraindications:
– evidence of infection and risk of bacteremia
– heart disease or atherosclerotic disease including
•
•
•
•
•
•
aortic stenosis
unstable angina
MI within 6 months of donation
high grade left main CAD
cyanotic heart disease
uncontrolled hypertension
– active seizure disorder
– significant cardiac or pulmonary disease not yet cleared for surgery
16
• many hospitals in Canada have
autologous donation programs
• patients deemed high risk at CBS may be
considered for in-hospital donation
17
• at CBS autologous donations are collected into "B-2's"
(RBC + FP)
• Hemoglobin 110 g/L Htc .33
(subsequent 105/.32)
• RBC's have 42 day shelf life
• FP issued only if requested by transfusing physician
• indicated only if 10% or greater change of receiving a
transfusion
18
Advantages
• prevents transfusion-transmitted disease
• prevents red cell alloimmunization
• supplements the blood supply
• provides compatible blood for patients with
alloantibodies
• prevents some adverse transfusion reactions
(febrile reactions, TRALI reactions, allergic reactions,
delayed hemolytic Tx reactions)
19
Disadvantages
• autologous donors have increased risk of reactions at donation (1 in
16,000 or about 12x higher than allogeneic donors)
– usually in young patients, underweight, previous reaction, or first time
donation
– not as likely in the elderly over 75, or on medications
• risk of driving to and from the donation
• does not affect the risk of bacterial contamination
• does not affect the risk of receiving the "wrong unit" (1 in 50,000)
• risk of receiving allogeneic blood before, or instead of autolgous
blood
• more costly than allogeneic
20
Disadvantages (con’t)
• risk of surgery date postponement
• blood is wasted if not transfused
• subjects patients to perioperative anemia
– in general physiological erythropoiesis is not effective in the time frame
that we provide
– (for optimal benefit should collect between 21 and 34 days prior to
surgery; not within 2 weeks prior to surgery)
• increases the likelihood of perioperative transfusion
– induced anemia
– know the "blood is there"
• doesn't decrease the risk of TACO
21
CSA standards:
• must test for:
–
–
–
–
anti-HIV 1/2
anti-HCV
HBsAg
anti-HTLV I/II
• NAT, HIV-1 p24 Ag, and syphilis are not required
** must have written policy on disposition of blood that is
repeat reactive to any of these tests
22
Autologous donations are collected at most
CBS permanent donor clinics for elective
surgery in otherwise healthy donors
• CBS has collection data since its
inception in 1998
23
Autologous Donations 1999 to 2007, Canadian Blood Services
14,000
12,000
2000
Number of Donations
10,000
2001
2002
8,000
2003
2004
6,000
2005
2006
1999
4,000
2007
2,000
0
5,739 12,037 10,565
9,All Regions 8,7
/ Centres / Clinics
7,
9,026
8,758
7,865
All Regions/Centres/Clinics
Year
24
6,579
5,878
4,531
Per Capita Autologous Donations 1999 to 2007, Canadian Blood Services
0.60
0.50
2000
Number of Donations per Capita
2001
0.40
2002
2003
2004
0.30
2005
2006
1999
0.20
2007
0.10
0.00
All Regions / Centres / Clinics
Year
25
Autologous Donations
by Fiscal Period
15,000
11,505
11,104
10,224
10,000
8,933
8,508
7,589
6,456
5,566
5,000
4,155
0
1999/00
2000/01
26
2001/02
2002/03
2003/04
2004/05
2005/06
2006/07
2007/08
Collections
12,000
10,000
8,000
6,000
4,000
2,000
0
2001-2002
2002-2003
2003-2004
2004-2005
2005-2006
Annualized
10,225
8,933
8,508
7,589
6,503
800
742
665
666
595
AUTOLOGOUS
DIRECTED
27
CBS Calgary autologous collections:
• 2001/02 259
• 2002/03 193
• 2003/04 855
• 2004/05 731
• 2005/06 564
• 2006/07 323
• 2007/08 year to date - 278
Simply looking at collection statistics at CBS
can be misleading.
28
Summary
•
•
Autologous collections are decreasing.
Utilization is about 50% or less.
We have incomplete information pertaining to:
1) hospital collection statistics
2) utilization data
3) appropriateness of the request for autologous
donation
4) appropriateness of the transfusion
5) surgical subspecialty use
6) additional requirements for allogeneic
transfusion
29
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
30
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
31
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%
(or an absolute decrease of 43.8%)
• 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
32
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
33
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
34
• 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
35
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
36
Case Study #3
• 63 year old female undergoing bilateral
mandibular osteotomy
• oral surgeon orders 2 units RBC
• donation takes place at CBS
• negative past history
• first unit anti-HCV positive
• *surgeon cancels surgery altogether
37
Case Study #4
• 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?
38
Most successful autologous programs have a dedicated
perioperative program that includes:
1)
2)
cooperation and communication between all physicians involved
appropriately indicated surgical procedures warranting autologous
donation
3) appropriately selected patients
4) have policies for managing TD positive or indeterminate units
5) donor/patient consent to proceed, and to release positive results
6) proper labelling (may include "biohazard" or "untested")
7) appropriate selection of volume of blood drawn
8) appropriate donation intervals, including timing before surgery
9) iron and/or erythropoietin therapy as appropriate
10) transfusion of autologous blood only if indicated, and at same
transfusion trigger as allogeneic
11) quality review and audit of the program, including utilization,
physician education
39
Acute normovolemic hemodilution
and
Cell Salvage
• CSA standards state that the blood centre
or transfusion service should be involved
in the development of the policies and
procedures used in the management of
the perioperative blood recovery program.
40
Questions?
41