Platelet transfusion 2013

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Platelet transfusion 2013

  1. 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. 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. 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
  4. 4. Sources for bacterial contamination of platelet components • Phlebotomy – Skin contaminants (inadequate disinfection) – Skin plug (large bore collection needle) • Processing – Contaminated collection bag, tubing, anticoagulant • Asymptomatic donor bacteremia
  5. 5. Bacterial Contamination of Platelets Components (05/1993-08/2013) • Coagulase negative Staph – 9 • Bacillus spp. – 4 • S.aureus – 5 • Serratia marcescens – 1 • S. viridans – 2 • Strep Group A – 1 • Klebsiella oxytoca – 1 • E.coli – 1 • Mixed gram negative - 1
  6. 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. 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
  8. 8. Apheresis Collection 1½ - 3 Hours Component Collected Anticoagulant Return Blood Filter Saline Blood Cell Separator Platelets Stem Cells Lymphocytes Granulocytes RBC Plasma
  9. 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. 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
  11. 11. Comparison Across Institutions (Blood suppliers) • ARC Apheresis Collection 12/01/06 – 07/31/08 – 781,936 collections – Confirmed positive – 130 (1:6015) – False negative – 9 (1:86,882) reported reactions – One fatality • Canadian Blood Services 03/2004 – 02/2006 – 43,732 collections – Confirmed positive – 3 (1:14,577) – False negative – 1 reported reaction, not fatal • Hēma-Quēbec 06/2002 – 02/2006 – 33,272 collections – Confirmed positive – 3 (1:11,091) – False negative – 1 reported reaction, possibly fatal
  12. 12. Comparison Across Institutions (Transfusion Services) • Johns Hopkins Passive Surveillance 03/2004 – 08/2007 – Two STR in 49,625 SDP transfusion(1:24,813); not fatal • CWRU Active Surveillance 07/1991 – 02/2000 and 03/2004 – 12/2006 – 1:2,060 culture positive at issue (50 units) – 42 units transfused – 5 reactions with demonstrated bacteremia (1:20,600) – 1 death (1:102,998)
  13. 13. MSKCC Platelet Transfusion Total STR 05/1993-02/2004 121,552 18** 1:6753 1.7/year 03/2004-12/2013 136,853 10/7* 1:13,685/19,550 1.0/0.7year ** two fatal Gram stain Component Age * 01/2009 Staph lugdunensis (2 recipients) 4+ 5 11/2011 Staph aureus 4+ 4 12/2011 Strep viridans Neg 4 03/2012 Strep viridans 2+ 4 03/2013 Staph aureus (2 recpients) 3+ 4 08/2013 Staph epidermis (2 recipients) 3+ 5 12/2013 Bacillus cereus 3+ 5 03/2004 – 12/2013 - 25,027 collections - confirmed positive – 2 (1:12,514) - False negative – 2 (1:12,514)
  14. 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. 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. 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.
  17. 17. MSKCC Platelet Transfusions * * Projected 0 2000 4000 6000 8000 10000 12000 14000 16000 18000 1997 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Unitstransfused *
  18. 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. 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
  20. 20. Platelet Transfusion Non-indications • ITP or TTP unless clinically significant bleeding • Prophylactic use in massive transfusion
  21. 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. 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. 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
  24. 24. MSKCC Transfusion Guidelines Platelets Inpatient (%) Outpatient (%) PLT CT < 10,000/μL 15 5 PLT CT < 20,000/μL 25 12 PLT CT < 50,000/μL 31 6 PLT CT < 100,000/μL 4 1
  25. 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. 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. 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. 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
  29. 29. Gmur: Lancet, 1991
  30. 30. Slichter: Blood, 1999
  31. 31. 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.
  32. 32. Friedman: Trans Med Rev, 2002
  33. 33. 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
  34. 34. 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
  35. 35. 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)
  36. 36. 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

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