Hemovigilance monitoring of platelet septic reactions with effective bacterial protection systems

Transfusion

Volumn 57, Issue 12, 2017, Pages 2946-2957

  Benjamin, Richard J ^a   Braschler, Thomas ^b   Weingand, Tina ^c   Corash, Laurence M ^a  

^a CERUS CORPORATION   (United States)

^b LUZERNER KANTONSSPITAL   (Switzerland)

^c Blutspendedienst Zentralschweiz SRK   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

AMOTOSALEN; THROMBOCYTE CONCENTRATE; FUROCOUMARIN DERIVATIVE; PHOTOSENSITIZING AGENT;

ADULT; AGED; ARTICLE; BACTERIUM CONTAMINATION; BACTERIUM CULTURE; BELGIUM; BLOOD SAFETY; ESCHERICHIA COLI; FATALITY; FEMALE; FRANCE; HEALTH PROGRAM; HUMAN; LACTOCOCCUS LACTIS; MAJOR CLINICAL STUDY; MALE; RISK ASSESSMENT; SEPSIS; SERRATIA MARCESCENS; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS AGALACTIAE; SWITZERLAND; THROMBOCYTE TRANSFUSION; ULTRAVIOLET A RADIATION; UNITED KINGDOM; BACTERIAL INFECTION; BLOOD TRANSFUSION REACTION; DISINFECTION; EUROPE; MICROBIOLOGICAL EXAMINATION; MICROBIOLOGY; PROCEDURES; THROMBOCYTE; TRANSMISSION; ULTRAVIOLET RADIATION;

BACTERIAL INFECTIONS; BACTERIOLOGICAL TECHNIQUES; BLOOD PLATELETS; BLOOD SAFETY; DISINFECTION; EUROPE; FUROCOUMARINS; HUMANS; PHOTOSENSITIZING AGENTS; TRANSFUSION REACTION; ULTRAVIOLET RAYS;

EID: 85039991386     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/trf.14284     Document Type: Article

References (51)

1. Benjamin RJ, McDonald CP. The international experience of bacterial screen testing of platelet components with an automated microbial detection system: a need for consensus testing and reporting guidelines. Transfus Med Rev 2014;28:61-71.
2. Stormer M, Vollmer T. Diagnostic methods for platelet bacteria screening: current status and developments. Transfus Med Hemother 2014;41:19-27.
3. Heaton WA, Good CE, Galloway-Haskins R, Yomtovian RA, Jacobs MR. Evaluation of a rapid colorimetric assay for detection of bacterial contamination in apheresis and pooled random-donor platelet units. Transfusion 2014;54:1634-41.
4. Brecher ME, Jacobs MR, Katz LM, et al. Survey of methods used to detect bacterial contamination of platelet products in the United States in 2011. Transfusion 2013;53:911-8.
5. Jacobs MR, Smith D, Heaton WA, Zantek ND, Good CE; PGD Study Group. Detection of bacterial contamination in prestorage culture-negative apheresis platelets on day of issue with the Pan Genera Detection test. Transfusion 2011;51:2573-82.
6. Allain JP, Owusu-Ofori AK, Assennato SM, Marschner S, Goodrich RP, Owusu-Ofori S. Effect of Plasmodium inactivation in whole blood on the incidence of blood transfusion-transmitted malaria in endemic regions: the African Investigation of the Mirasol System (AIMS) randomised controlled trial. Lancet 2016;387:1753-61.
7. Kaplan A, Lindgren B, Marschner S, et al. Evaluation of the post-transfusion platelet increment and safety of riboflavin-based pathogen reduction technology (PRT) treated platelet products stored in platelet additive solution for 5 days or less versus 6-7 days. Transfus Apher Sci 2016;54:248-52.
8. Mirasol Clinical Evaluation Study Group. A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology. Transfusion 2010;50:2362-75.
9. Rebulla P, Vaglio S, Beccaria F, et al. Clinical effectiveness of platelets in additive solution treated with two commercial pathogen-reduction technologies. Transfusion 2017;57:1171-83.
10. McCullough J, Vesole DH, Benjamin RJ, et al. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial. Blood 2004;104:1534-41.
11. Knutson F, Osselaer J, Pierelli L, et al. A prospective, active haemovigilance study with combined cohort analysis of 19 175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment. Vox Sang 2015;109:343-52.
12. Corash L, Benjamin RJ. The role of hemovigilance and postmarketing studies when introducing innovation into transfusion medicine practice: the amotosalen-ultraviolet A pathogen reduction treatment model. Transfusion 2016;56Suppl 1:S29-38.
13. McDonald CP, Allen J, Pitt T, et al. Evaluation of the Mirasol pathogen inactivation system as an alternative to bacterial screening of platelet components. Vox Sang 2016;111(Suppl1). Abstract 3A-S05-03.24.
14. Allen J, Pitt T, Aplin K, Ball J, et al. Evaluation of the Cerus INTERCEPT pathogen inactivation system as an alternative to bacterial screening of platelet components. Vox Sang 2016;111(Suppl 1). Abstract 3A-S05-04.25.
15. Kwon SY, Kim IS, Bae JE, et al. Pathogen inactivation efficacy of Mirasol PRT System and Intercept Blood System for non-leucoreduced platelet-rich plasma-derived platelets suspended in plasma. Vox Sang 2014;107:254-60.
16. McDonald C, Ball J, Allen J, et al. The first year of bacterial screening of platelet components—the English experience. Vox Sang 2012;103(Suppl1):176. Abstract P-341.
17. Wagner SJ, Eder AF. A model to predict the improvement of automated blood culture bacterial detection by doubling platelet sample volume. Transfusion 2007;47:430-3.
18. McDonald C, Allen J, Brailsford S, et al. Bacterial screening of platelet components by National Health Service Blood and Transplant, an effective risk reduction measure. Transfusion 2017;57:1122-31.
19. Rhame FS, McCullough J, Cameron S, et al. Pseudomonas cepacia infections caused by thawing cryoprecipitate in a contaminated water bath (abstract). Transfusion 1979;19:653.
20. Mastronardi C, Yang L, Halpenny M, Tove B, Ramírez-Arcos S. Evaluation of the sterility testing process of hematopoietic stem cells at Canadian Blood Services. Transfusion 2012;52:1778-84.
21. Eder AF, Goldman M. How do I investigate septic transfusion reactions and blood donors with culture-positive platelet donations? Transfusion 2011;51:1662-8.
22. Stainsby D, Jones H, Asher D, et al. Serious hazards of transfusion: a decade of hemovigilance in the UK. Transfus Med Rev 2006;20:273-82.
23. Serious Hazards of Transfusion (SHOT). Serious Hazards of Transfusion annual reports and summaries 1996-2015 [cited 2017 Jun 20]. Available from: https://www.shotuk.org/shot-reports/
24. Swissmedic. Hemovigilance annual reports 2003-2014 [cited 2017 Jun 20]. Available from: https://www.swissmedic.ch/marktueberwachung/00138/00188/index.html?lang=en
25. Federaal Agentschap voor Geneesmiddelen en Gezondsheidsproducten (FAGG). Federaal Agentschap voor Geneesmiddelen en Gezondsheidsproducten Annual Hemovigilance Reports 2006-2015 [cited 2017 Jun 20]. Available from: https://www.fagg-afmps.be/nl/MENSELIJK_gebruik/gezondheidsproducten/bloed_en_bloedbestanddelen/hemovigilantie/jaarverslagen
26. Centers for Disease Control and Prevention (CDC). National Healthcare Safety Network imputability criteria [cited 2017 Jun 20]. Available from: http://www.cdc.gov/nhsn/PDFs/Biovigilance/Appendix-A-BV-Protocol-1-3-1-June-2011.pdf
27. Cazenave JP, Isola H, Waller C, et al. Use of additive solutions and pathogen inactivation treatment of platelet components in a regional blood center: impact on patient outcomes and component utilization during a 3-year period. Transfusion 2011;51:622-9.
28. Rasonglés P, Angelini-Tibert MF, Simon P, et al. Transfusion of platelet components prepared with photochemical pathogen inactivation treatment during a Chikungunya virus epidemic in Ile de La Réunion. Transfusion 2009;49:1083-91.
29. Lafeuillade B, Eb F, Ounnoughene N, et al. Residual risk and retrospective analysis of transfusion-transmitted bacterial infection reported by the French National Hemovigilance Network from 2000 to 2008. Transfusion 2015;55:636-46.
30. Agence Nationale de Sécurité deu Mé dicament et des Produits de Santé (ANSM). Annual Hemovigilance Activity Reports (2001-2015) [cited 2017 Jun 20]. Available from: http://ansm.sante.fr/Mediatheque/Publications/Bilans-Rapports-d-activite-Bilans-et-rapports-d-activite#folder_26762
31. Pietersz RN, Reesink HW, Panzer S, et al. Bacterial contamination in platelet concentrates. Vox Sang 2014;106:256-83.
32. Cazenave JP. [Photochemical inactivation of pathogens in platelets and plasma: five years of clinical use in routine and hemovigilance. Towards a change of paradigm in transfusion safety]. Transfus Clin Biol 2011;18:53-61.
33. Osselaer JC, Cazenave JP, Lambermont M, et al. An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment. Vox Sang 2008;94:315-23.
34. Getz TM, Montgomery RK, Bynum JA, Aden JK, Pidcoke HV, Cap AP. Storage of platelets at 4°C in platelet additive solutions prevents aggregate formation and preserves platelet functional responses. Transfusion 2016;56:1320-8.
35. Dumont LJ, Cancelas JA, Dumont DF, et al. A randomized controlled trial evaluating recovery and survival of 6% dimethyl sulfoxide-frozen autologous platelets in healthy volunteers. Transfusion 2013;53:128-37.
36. Murphy WG, Foley M, Doherty C, et al. Screening platelet concentrates for bacterial contamination: low numbers of bacteria and slow growth in contaminated units mandate an alternative approach to product safety. Vox Sang 2008;95:13-9.
37. Tomasulo PA, Wagner SJ. Predicting improvement in detection of bacteria in apheresis platelets by maintaining constant component sampling proportion. Transfusion 2013;53:835-42.
38. Wagner SJ, Moroff G, Katz AJ, Friedman LI. Comparison of bacteria growth in single and pooled platelet concentrates after deliberate inoculation and storage. Transfusion 1995;35:298-302.
39. Wagner SJ, Robinette D. Evaluation of an automated microbiologic blood culture device for detection of bacteria in platelet components. Transfusion 1998;38:674-9.
40. Benjamin RJ, Wagner SJ. The residual risk of sepsis: modeling the effect of concentration on bacterial detection in two-bottle culture systems and an estimation of false-negative culture rates. Transfusion 2007;47:1381-9.
41. Brecher ME, Means N, Jere CS, Heath D, Rothernberg S, Stutzman LC. Evaluation of an automated culture system for detecting bacterial contamination of platelets: an analysis with 15 contaminating organisms. Transfusion 2001;41:477-82.
42. Eder AF, Kennedy JM, Dy BA, et al. Limiting and detecting bacterial contamination of apheresis platelets: inlet-line diversion and increased culture volume improve component safety. Transfusion 2009;49:1554-63.
43. Lin L, Dikeman R, Molini B, et al. Photochemical treatment of platelet concentrates with amotosalen and long-wavelength ultraviolet light inactivates a broad spectrum of pathogenic bacteria. Transfusion 2004;44:1496-504.
44. Benjamin RJ, Dy B, Perez J, Eder AF, Wagner SJ. Bacterial culture of apheresis platelets: a mathematical model of the residual rate of contamination based on unconfirmed positive results. Vox Sang 2014;106:23-30.
45. Kamel H, Townsend M, Bravo M, Vassallo RR. Improved yield of minimal proportional sample volume platelet bacterial culture. Transfusion 2017;57:2413-9.
46. Hong H, Xiao W, Lazarus HM, God CE, Maitta RW, Jacobs MR. Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance. Blood 2016;127:496-502.
47. Benjamin RJ. Transfusion-related sepsis: a silent epidemic. Blood 2016;127:380-1.
48. Lamy B, Dargére S, Arendrup MC, Parienti JJ, Tattevin P. How to optimize the use of blood cultures for the diagnosis of bloodstream infections? A state-of-the art. Front Microbiol 2016;7:697.
49. Wagner SJ, Benjamin RJ, Hapip CA, et al. Investigation of bacterial inactivation in apheresis platelets with 24 or 30 hours between inoculation and inactivation. Vox Sang 2016;111:226-34.
50. Benjamin RJ, Wagner SJ. Bacterial pathogen reduction requires validation under conditions of intended use. Transfusion 2015;55:2060-3.
51. Schmidt M, Hourfar MK, Sireis W, et al. Evaluation of the effectiveness of a pathogen inactivation technology against clinically relevant transfusion-transmitted bacterial strains. Transfusion 2015;55:2104-12.