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Platelet transfusion 2013
1. Clinical Case
• 04/19/02 61 year old male with myeloma received auto PBSCT
• 04/21/02 Fever, LLL pneumonia; Rx with Timentin and Aztreonam
• 04/24/02 Vancomycin added
• 04/24/02 Developed mild chills with 100 mL pooled plts; transfusion
d/c; developed T38.4, BP 60/30, O2 Sat 91%, HR 140 one
hour after transfusion d/c; admitted to ICU for presumptive
septic shock
• 04/26/02 Blood Bank notified of subsequent events
Gram stain of saved segment: 2+ Gram-negative rods
Culture of saved segment: 4+ Klebsiella oxytoca, sensitive to
Timentin and Aztreonam
• 05/30/02 Pt died with multiorgan failure
No post transfusion blood cultures grew Klebsiella
Final source of contaminated platelet component remains
undetermined
2. Bacterial Contamination/ Sepsis
• usually during transfusion but may occur up to 4-6 h post
transfusion
• high fever, severe chill, nausea, vomiting, hypotension,
dyspnea
• can develop shock, DIC, multiorgan system failure
3. Septic Transfusion Reaction
• Bacterial sepsis has been a long-standing, well-known risk of
morbidity and mortality related to platelet transfusion therapy
• Estimates of incidence vary, but universally acknowledged as most
frequent infectious transfusion risk in USA
• Since the early 1980s, more/most attention paid to transmission of
viral infection
• AABB required implementation of methods to limit and detect
bacterial contamination in platelet components in March 2004
• Since 2004, STR have decreased but have not been eliminated
6. Bacterial Sepsis
Determinants of Clinical
Severity
• Organism
– Gram-negative organisms elaborating endotoxins
– Virulence factors permitting bacterial growth
• Bacterial load infused
– Time of storage: >3 days for platelets
– Volume of component
• Host characteristics
– Concomitant administration of antibiotic
– Degree of immunosuppression
– Neutropenia
7. Preparation of Blood Components
Red Cells Platelet-Rich Plasma
Red Cells Platelet Concentrate Plasma
Storage
1-6°C 20-24°C -18°C
42 days 5 days 1 year
9. Platelet Preparation Process
• Prepared from whole blood or apheresis collection (MSKCC
100%, USA 87%)
• Diversion of first 30-50 mL
• Store at standard condition (20-24oC) for 24-36 h, 8 mL sample
obtained for culture (SCD), culture in FDA approved system 18-
24 h, released to available inventory usually day 3 of 5 day
expiry
• Estimated sensitivity for day 1 culture is only 22-40%
• Residual risk of bacterial contamination on day of transfusion
or outdate is 1:3,000 - 5,000 (clinical significance unknown)
10. Bacterial Infection by
Platelets
From “Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2011”
http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/TransfusionDonationFatalities/UCM300764.pdf
14. AABB Bulletin # 12-04, October 4, 2012:
“Recommendations to Address Residual Risk of Bacterial Contamination of
Platelets”
• Develop a policy to further reduce the residual risk
• Improve the recognition and monitoring of STR
• Optimize the appropriate transfusion practice
15. Bacterial Contamination of Platelet Components
Possible Future Preventive Measures
• Lower storage temperature
• Improve culture methods (↑ volume tested, test split units, sample later)
• Point-of-issue testing (must be simple, rapid):
Culture platelets after the first 24 hours of storage and then retest
day four or day five platelets just once with rapid test on the day of
transfusion
• Pathogen inactivation (loss of cells, ↓ cell function and survival, toxicity, neo-
antigenicity, and expense)
• Limit platelet transfusion
16. Gram Staining of Apheresis Platelets
(initiated on 02/24/14)
All apheresis platelets currently in our available
inventory on day four (4) of their shelf life will be
quarantined. A sample will be sent to Microbiology for
Gram stain. A sample of all day four (4) and day five (5)
apheresis platelets received from suppliers will be sent
to Microbiology for Gram stain prior platelets being
placed into available inventory. Apheresis platelets will
remain in quarantine pending the receipt of Gram stain
results from Microbiology. Any deviation from this
policy requires a Blood Bank physician’s approval.
18. MSKCC Transfusion Guidelines
PLATELETS
1. PLT CT <10,000/uL in non-bleeding patient
WITHOUT other associated hemostatic defects
2. PLT CT <20,000/uL in non-bleeding patient WITH
other associated hemostatic defects
3. PLT CT <50,000/uL and minor bleeding, severe DIC,
invasive procedure or perioperative patient
19. MSKCC Transfusion Guidelines
PLATELETS
4. PLT CT <100,000/uL and clinically
significant bleeding (requiring RBC txn or
into closed space) or bleeding risk
5. Massive transfusion (>8 units RBC/24hr),
continued bleeding and PLT CT
unavailable
6. Other
21. Concept of Patient Blood Management
• June 2011, HHS stressed the importance of strengthening
blood management systems to promote the rational use of
blood, limit the number of unnecessary transfusions, reduce
transfusion risks, improve patient care and save hospital
resources
• Development of transfusion guidelines and utilization review
• Use of pharmaceuticals to limit blood loss and blood
conservation methods (IOBS, ANH) as appropriate
• Requires evidence based practice (when available)
• Requires multidisciplinary approach
22. Transfusion Medicine Service
Transfusion Service and Donor Room
• Clinical activities encompass all aspects of Transfusion Medicine
- collection, preparation, testing, storage, inventory
management and transfusion of blood components
(RBC 23,000 PLT 15,000 FFP 3,000 collections 6,000)
- consultation, evaluation and management of clinical issues
requiring transfusion therapy
- evaluation of transfusion reactions and difficult
crossmatches
- performance of therapeutic apheresis and stem cell
collection (900 procedures) and associated patient
management
23. Considerations for Risk Reduction in
Transfusion
• transfusion has never undergone prospective randomized
testing in the manner expected of a new drug
• repletion of elements of hemostasis effective in bleeding
patient
• prophylaxis to prevent bleeding in setting of mild-moderate
abnormal test result often lacks evidence-based support
• associated with unfavorable risk-to-benefit ratio
25. Prophylactic Platelet Transfusion
• most common use of platelet transfusion
• most previous research focused on optimal dose and threshold
• effectiveness is uncertain/unproven compared to therapeutic
strategy
• previous non-randomized comparisons of therapeutic
strategy with historical prophylactic controls have reported no
increase in major bleeding episodes or RBC transfusion, but
significant decrease in platelet transfusion
• current randomized controlled trial to compare prophylactic v
therapeutic in hematologic malignancies for safety and clinical
effectiveness
• if therapeutic is non-inferior, then potential benefit of decreased
transfusion: decreased risks, reactions, cost
26. Prophylactic Platelet Transfusion for Invasive Bedside
Procedures
• bronchoscopy, endoscopy, LP, paracentesis, thoracentesis,
CVC insertion all part of modern medical practice
• no published evidence for increased risks of procedure-
related hemorrhage and no controlled studies that
indicate what platelet count represents contraindication or
that prophylactic transfusion reduces risk of hemorrhage
• no evidence that ASA or NSAIDS increase risk
27. Relationship between hemorrhage and the platelet count in
non-transfused thrombocytopenic patients
Slichter SJ. Relationship between platelet count and bleeding risk in thrombocytopenic patients.
Transfus Med Rev. 2004 Jul;18(3):153-167 Gaydos, et.al:NEJM, 1962
28. Fecal blood loss in
thrombocytopenic patients
Slichter SJ. Relationship between platelet count and bleeding risk in thrombocytopenic patients.
Transfus Med Rev. 2004 Jul;18(3):153-167 Slichter:Clin Haem, 1978
33. Slichter SJ, Kaufman RM, Assmann SF, et al. Dose of Prophylactic Platelet Transfusions and
Prevention of Hemorrhage. N Engl J Med. 2010 Feb 18; 362 (7): 600-613.
35. German Therapeutic v Prophylactic Platelet Transfusion Study
Wandt:Lancet,2012
• randomized, multicentre, parallel-group trial
• stable adults, AML and auto SCT (391 patients)
Therapeutic Prophylactic (≤ 10,000/mcL)
Platelets transfused (u) 1.6 2.4 33.5% reduction p < 0.0001
WHO gr ≥ 2 (% per treat) 42 19 p < 0.0001
• 93% of bleeds WHO grade 2
• overall survival, RBC transfusion, hospital days, side effects, durations of TCP and time to
onset of first bleed did not differ
• study not powered to prove significant difference in WHO gr 4 bleeds or lethal events
36. German Therapeutic v Prophylactic Platelet Transfusion
Study
Therapeutic Prophylactic (≤ 10,000/mcL)
AML WHO grade 4 bleed 13 4
1 vaginal bleed 20 myomas (44,000) 4 retinal bleed with visual impairment
4 retinal bleed with visual impairment CT not performed after HA
6 minor cerebral bleed (CT after HA) 2 plt ct > 10,000
2 fatal cerebral bleed
(both HA; protocol violations; 1 plt ct < 10,000)
6 plt ct >10,000
37. TOPPS Trial
• 600 patients
• randomized, non-inferiority trial of therapeutic v prophylactic (<10,000/mcL)
• primary outcome: % patients with WHO grade ≥ 2 bleed
• non-inferiority margin: 15% difference
• adults, hematologic malignancies, chemo or SCT
• no difference in period of TCP, hospital days, SAE
Therapeutic Prohylactic
% transfused 59 89
total transfusion (u) 1.7 3.0
WHO gr ≥ 2 (%) 50 43 non inferiority p = 0.06
auto SCT 47 45 p = 0.04
bleeding days 1.7 1.2
WHO gr 3 – 4* 6/300 1/298 p = 0.13
*Only 2 pts with plt ct < 10,000 (median 16,000; range 3 – 42,000)
38. Platelet Transfusion Guidelines
1) PLT CT < 10,000/mcL
2) PLT CT < 20,000/mcL for outpatient
3) PLT CT < 20,000/mcL for recent hemorrhage (within 5 days)
4) PLT CT < 50,000/mcL for DIC
5) PLT CT < 50,000/mcL for existing CNS lesion
6) PLT CT < 50,000/mcL for invasive procedure (except bone
marrow biopsy)
7) PLT CT < 50,000/mcL for active bleeding not controlled by
local measures
8) PLT CT < 100,000/mcL for CNS or pulmonary invasive
procedure (except lumbar puncture) or bleeding
9) PLT CT < 100,000/mcL for active bleeding requiring RBC
transfusion
10) other