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Published in: Annals of Hematology 8/2017

Open Access 01-08-2017 | Review Article

Pathogen reduction/inactivation of products for the treatment of bleeding disorders: what are the processes and what should we say to patients?

Authors: Giovanni Di Minno, David Navarro, Carlo Federico Perno, Mariana Canaro, Lutz Gürtler, James W. Ironside, Hermann Eichler, Andreas Tiede

Published in: Annals of Hematology | Issue 8/2017

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Abstract

Patients with blood disorders (including leukaemia, platelet function disorders and coagulation factor deficiencies) or acute bleeding receive blood-derived products, such as red blood cells, platelet concentrates and plasma-derived products. Although the risk of pathogen contamination of blood products has fallen considerably over the past three decades, contamination is still a topic of concern. In order to counsel patients and obtain informed consent before transfusion, physicians are required to keep up to date with current knowledge on residual risk of pathogen transmission and methods of pathogen removal/inactivation. Here, we describe pathogens relevant to transfusion of blood products and discuss contemporary pathogen removal/inactivation procedures, as well as the potential risks associated with these products: the risk of contamination by infectious agents varies according to blood product/region, and there is a fine line between adequate inactivation and functional impairment of the product. The cost implications of implementing pathogen inactivation technology are also considered.
Literature
1.
go back to reference Darby SC, Kan SW, Spooner RJ, Giangrande PL, Hill FG, Hay CR, Lee CA, Ludlam CA, Williams M (2007) Mortality rates, life expectancy, and causes of death in people with hemophilia A or B in the United Kingdom who were not infected with HIV. Blood 110(3):815–825. doi:10.1182/blood-2006-10-050435 CrossRefPubMed Darby SC, Kan SW, Spooner RJ, Giangrande PL, Hill FG, Hay CR, Lee CA, Ludlam CA, Williams M (2007) Mortality rates, life expectancy, and causes of death in people with hemophilia A or B in the United Kingdom who were not infected with HIV. Blood 110(3):815–825. doi:10.​1182/​blood-2006-10-050435 CrossRefPubMed
5.
13.
go back to reference Harvey AR, Basavaraju SV, Chung KW, Kuehnert MJ (2015) Transfusion-related adverse reactions reported to the National Healthcare Safety Network Hemovigilance Module, United States, 2010 to 2012. Transfusion 55(4):709–718. doi:10.1111/trf.12918 CrossRefPubMed Harvey AR, Basavaraju SV, Chung KW, Kuehnert MJ (2015) Transfusion-related adverse reactions reported to the National Healthcare Safety Network Hemovigilance Module, United States, 2010 to 2012. Transfusion 55(4):709–718. doi:10.​1111/​trf.​12918 CrossRefPubMed
14.
go back to reference Dorsey KA, Moritz ED, Steele WR, Eder AF, Stramer SL (2013) A comparison of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and human T-lymphotropic virus marker rates for directed versus volunteer blood donations to the American Red Cross during 2005 to 2010. Transfusion 53(6):1250–1256. doi:10.1111/j.1537-2995.2012.03904.x CrossRefPubMed Dorsey KA, Moritz ED, Steele WR, Eder AF, Stramer SL (2013) A comparison of human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and human T-lymphotropic virus marker rates for directed versus volunteer blood donations to the American Red Cross during 2005 to 2010. Transfusion 53(6):1250–1256. doi:10.​1111/​j.​1537-2995.​2012.​03904.​x CrossRefPubMed
16.
go back to reference Hardwick J (2008) Blood processing. International Society of Blood Transfusion (ISBT) Science Series 3:148–176 Hardwick J (2008) Blood processing. International Society of Blood Transfusion (ISBT) Science Series 3:148–176
17.
go back to reference Patient.co.uk (2015) Blood Products for Transfusion Patient.co.uk (2015) Blood Products for Transfusion
20.
go back to reference Funk MB, Heiden M, Volkers P, Lohmann A, Keller-Stanislawski B (2015) Evaluation of risk minimisation measures for blood components - based on reporting rates of transfusion-transmitted reactions (1997-2013). Transfus med Hemother 42(4):240–246. doi:10.1159/000381996 CrossRefPubMedPubMedCentral Funk MB, Heiden M, Volkers P, Lohmann A, Keller-Stanislawski B (2015) Evaluation of risk minimisation measures for blood components - based on reporting rates of transfusion-transmitted reactions (1997-2013). Transfus med Hemother 42(4):240–246. doi:10.​1159/​000381996 CrossRefPubMedPubMedCentral
21.
go back to reference Hourfar MK, Jork C, Schottstedt V, Weber-Schehl M, Brixner V, Busch MP, Geusendam G, Gubbe K, Mahnhardt C, Mayr-Wohlfart U, Pichl L, Roth WK, Schmidt M, Seifried E, Wright DJ, German Red Cross NATSG (2008) Experience of German Red Cross blood donor services with nucleic acid testing: results of screening more than 30 million blood donations for human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus. Transfusion 48(8):1558–1566. doi:10.1111/j.1537-2995.2008.01718.x CrossRefPubMed Hourfar MK, Jork C, Schottstedt V, Weber-Schehl M, Brixner V, Busch MP, Geusendam G, Gubbe K, Mahnhardt C, Mayr-Wohlfart U, Pichl L, Roth WK, Schmidt M, Seifried E, Wright DJ, German Red Cross NATSG (2008) Experience of German Red Cross blood donor services with nucleic acid testing: results of screening more than 30 million blood donations for human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus. Transfusion 48(8):1558–1566. doi:10.​1111/​j.​1537-2995.​2008.​01718.​x CrossRefPubMed
22.
go back to reference Velati C, Romano L, Fomiatti L, Baruffi L, Zanetti AR, Group SR (2008) Impact of nucleic acid testing for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus on the safety of blood supply in Italy: a 6-year survey. Transfusion 48(10):2205–2213. doi:10.1111/j.1537-2995.2008.01813.x CrossRefPubMed Velati C, Romano L, Fomiatti L, Baruffi L, Zanetti AR, Group SR (2008) Impact of nucleic acid testing for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus on the safety of blood supply in Italy: a 6-year survey. Transfusion 48(10):2205–2213. doi:10.​1111/​j.​1537-2995.​2008.​01813.​x CrossRefPubMed
23.
go back to reference Barjas-Castro ML, Angerami RN, Cunha MS, Suzuki A, Nogueira JS, Rocco IM, Maeda AY, Vasami FG, Katz G, Boin IF, Stucchi RS, Resende MR, Esposito DL, de Souza RP, da Fonseca BA, Addas-Carvalho M (2016) Probable transfusion-transmitted Zika virus in Brazil. Transfusion 56(7):1684–1688. doi:10.1111/trf.13681 CrossRefPubMed Barjas-Castro ML, Angerami RN, Cunha MS, Suzuki A, Nogueira JS, Rocco IM, Maeda AY, Vasami FG, Katz G, Boin IF, Stucchi RS, Resende MR, Esposito DL, de Souza RP, da Fonseca BA, Addas-Carvalho M (2016) Probable transfusion-transmitted Zika virus in Brazil. Transfusion 56(7):1684–1688. doi:10.​1111/​trf.​13681 CrossRefPubMed
30.
go back to reference EDQM (2010) European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS). Symposium on implementation of pathogen reduction technologies for blood components—executive summary EDQM (2010) European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS). Symposium on implementation of pathogen reduction technologies for blood components—executive summary
34.
go back to reference Devine DV, Howe D (2010) Processing of whole blood into cellular components and plasma. International Society of Blood Transfusion (ISBT) Science Series 5:78–82 Devine DV, Howe D (2010) Processing of whole blood into cellular components and plasma. International Society of Blood Transfusion (ISBT) Science Series 5:78–82
37.
go back to reference Muller B, Walther-Wenke G, Kalus M, Alt T, Bux J, Zeiler T, Schottstedt V (2014) Routine bacterial screening of platelet concentrates by flow cytometry and its impact on product safety and supply. Vox Sang. doi:10.1111/vox.12214 Muller B, Walther-Wenke G, Kalus M, Alt T, Bux J, Zeiler T, Schottstedt V (2014) Routine bacterial screening of platelet concentrates by flow cytometry and its impact on product safety and supply. Vox Sang. doi:10.​1111/​vox.​12214
39.
go back to reference Kou YT, Pagotto F, Hannach B, Ramirez-Arcos S (2015) Fatal false-negative transfusion infection involving a buffy coat platelet pool contaminated with biofilm-positive Staphylococcus epidermidis: a case report. Transfusion 55(10):2384–2389. doi:10.1111/trf.13154 CrossRefPubMed Kou YT, Pagotto F, Hannach B, Ramirez-Arcos S (2015) Fatal false-negative transfusion infection involving a buffy coat platelet pool contaminated with biofilm-positive Staphylococcus epidermidis: a case report. Transfusion 55(10):2384–2389. doi:10.​1111/​trf.​13154 CrossRefPubMed
40.
go back to reference Chhabra P, Payne DC, Szilagyi PG, Edwards KM, Staat MA, Shirley SH, Wikswo M, Nix WA, Lu X, Parashar UD, Vinje J (2013) Etiology of viral gastroenteritis in children <5 years of age in the United States, 2008-2009. J Infect dis 208(5):790–800. doi:10.1093/infdis/jit254 CrossRefPubMed Chhabra P, Payne DC, Szilagyi PG, Edwards KM, Staat MA, Shirley SH, Wikswo M, Nix WA, Lu X, Parashar UD, Vinje J (2013) Etiology of viral gastroenteritis in children <5 years of age in the United States, 2008-2009. J Infect dis 208(5):790–800. doi:10.​1093/​infdis/​jit254 CrossRefPubMed
42.
go back to reference Zhang W, Li L, Deng X, Blumel J, Nubling CM, Hunfeld A, Baylis SA, Delwart E (2016) Viral nucleic acids in human plasma pools. Transfusion. doi:10.1111/trf.13692 Zhang W, Li L, Deng X, Blumel J, Nubling CM, Hunfeld A, Baylis SA, Delwart E (2016) Viral nucleic acids in human plasma pools. Transfusion. doi:10.​1111/​trf.​13692
50.
go back to reference Lusher JM, Arkin S, Abildgaard CF, Schwartz RS (1993) Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A. Safety, efficacy, and development of inhibitors. Kogenate previously untreated patient study group. N Engl J med 328(7):453–459. doi:10.1056/NEJM199302183280701 CrossRefPubMed Lusher JM, Arkin S, Abildgaard CF, Schwartz RS (1993) Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A. Safety, efficacy, and development of inhibitors. Kogenate previously untreated patient study group. N Engl J med 328(7):453–459. doi:10.​1056/​NEJM199302183280​701 CrossRefPubMed
54.
go back to reference Jiang R, Monroe T, McRogers R, Larson PJ (2002) Manufacturing challenges in the commercial production of recombinant coagulation factor VIII. Haemophilia 8(Suppl 2):1–5CrossRefPubMed Jiang R, Monroe T, McRogers R, Larson PJ (2002) Manufacturing challenges in the commercial production of recombinant coagulation factor VIII. Haemophilia 8(Suppl 2):1–5CrossRefPubMed
55.
go back to reference Calizzani G, Profili S, Candura F, Lanzoni M, Vaglio S, Cannata L, Liumbruno GM, Franchini M, Mannucci PM, Grazzini G (2013) The demand for factor VIII and for factor IX and the toll fractionation product surplus management. Blood Transfus 11(Suppl 4):s64–s76. doi:10.2450/2013.011s PubMedPubMedCentral Calizzani G, Profili S, Candura F, Lanzoni M, Vaglio S, Cannata L, Liumbruno GM, Franchini M, Mannucci PM, Grazzini G (2013) The demand for factor VIII and for factor IX and the toll fractionation product surplus management. Blood Transfus 11(Suppl 4):s64–s76. doi:10.​2450/​2013.​011s PubMedPubMedCentral
57.
go back to reference Farcet MR, Lackner C, Antoine G, Rabel PO, Wieser A, Flicker A, Unger U, Modrof J, Kreil TR (2016) Hepatitis E virus and the safety of plasma products: investigations into the reduction capacity of manufacturing processes. Transfusion 56(2):383–391. doi:10.1111/trf.13343 CrossRefPubMed Farcet MR, Lackner C, Antoine G, Rabel PO, Wieser A, Flicker A, Unger U, Modrof J, Kreil TR (2016) Hepatitis E virus and the safety of plasma products: investigations into the reduction capacity of manufacturing processes. Transfusion 56(2):383–391. doi:10.​1111/​trf.​13343 CrossRefPubMed
58.
go back to reference Di Minno G, Perno CF, Tiede A, Navarro D, Canaro M, Guertler L, Ironside JW (2015) Current concepts in the prevention of pathogen transmission via blood/plasma-derived products for bleeding disorders. Blood rev. doi:10.1016/j.blre.2015.07.004 Di Minno G, Perno CF, Tiede A, Navarro D, Canaro M, Guertler L, Ironside JW (2015) Current concepts in the prevention of pathogen transmission via blood/plasma-derived products for bleeding disorders. Blood rev. doi:10.​1016/​j.​blre.​2015.​07.​004
59.
go back to reference Allain JP, Owusu-Ofori AK, Assennato SM, Marschner S, Goodrich RP, Owusu-Ofori S (2016) 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 387(10029):1753–1761. doi:10.1016/S0140-6736(16)00581-X CrossRefPubMed Allain JP, Owusu-Ofori AK, Assennato SM, Marschner S, Goodrich RP, Owusu-Ofori S (2016) 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 387(10029):1753–1761. doi:10.​1016/​S0140-6736(16)00581-X CrossRefPubMed
60.
go back to reference Shepel M, Boyd J, Luider J, Gibb AP (2001) Interaction of Yersinia enterocolitica and Y. pseudotuberculosis with platelets. J med Microbiol 50(12):1030–1038CrossRefPubMed Shepel M, Boyd J, Luider J, Gibb AP (2001) Interaction of Yersinia enterocolitica and Y. pseudotuberculosis with platelets. J med Microbiol 50(12):1030–1038CrossRefPubMed
61.
63.
go back to reference Lambrecht B, Mohr H, Knuver-Hopf J, Schmitt H (1991) Photoinactivation of viruses in human fresh plasma by phenothiazine dyes in combination with visible light. Vox Sang 60(4):207–213CrossRefPubMed Lambrecht B, Mohr H, Knuver-Hopf J, Schmitt H (1991) Photoinactivation of viruses in human fresh plasma by phenothiazine dyes in combination with visible light. Vox Sang 60(4):207–213CrossRefPubMed
68.
go back to reference Ciaravino V, McCullough T, Cimino G (2003) The role of toxicology assessment in transfusion medicine. Transfusion 43(10):1481–1492CrossRefPubMed Ciaravino V, McCullough T, Cimino G (2003) The role of toxicology assessment in transfusion medicine. Transfusion 43(10):1481–1492CrossRefPubMed
74.
go back to reference Knutson F, Osselaer J, Pierelli L, Lozano M, Cid J, Tardivel R, Garraud O, Hervig T, Domanovic D, Cukjati M, Gudmundson S, Hjalmarsdottir IB, Castrillo A, Gonzalez R, Brihante D, Santos M, Schlenke P, Elliott A, Lin JS, Tappe D, Stassinopoulos A, Green J, Corash L (2015) A prospective, active haemovigilance study with combined cohort analysis of 19,175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment. Vox Sang 109(4):343–352. doi:10.1111/vox.12287 CrossRefPubMedPubMedCentral Knutson F, Osselaer J, Pierelli L, Lozano M, Cid J, Tardivel R, Garraud O, Hervig T, Domanovic D, Cukjati M, Gudmundson S, Hjalmarsdottir IB, Castrillo A, Gonzalez R, Brihante D, Santos M, Schlenke P, Elliott A, Lin JS, Tappe D, Stassinopoulos A, Green J, Corash L (2015) A prospective, active haemovigilance study with combined cohort analysis of 19,175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment. Vox Sang 109(4):343–352. doi:10.​1111/​vox.​12287 CrossRefPubMedPubMedCentral
77.
80.
go back to reference Kerkhoffs JL, van Putten WL, Novotny VM, Te Boekhorst PA, Schipperus MR, Zwaginga JJ, van Pampus LC, de Greef GE, Luten M, Huijgens PC, Brand A, van Rhenen DJ, Dutch-Belgian Hcg (2010) Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction. Br J Haematol 150(2):209–217. doi:10.1111/j.1365-2141.2010.08227.x PubMed Kerkhoffs JL, van Putten WL, Novotny VM, Te Boekhorst PA, Schipperus MR, Zwaginga JJ, van Pampus LC, de Greef GE, Luten M, Huijgens PC, Brand A, van Rhenen DJ, Dutch-Belgian Hcg (2010) Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction. Br J Haematol 150(2):209–217. doi:10.​1111/​j.​1365-2141.​2010.​08227.​x PubMed
81.
go back to reference Snyder E, McCullough J, Slichter SJ, Strauss RG, Lopez-Plaza I, Lin JS, Corash L, Conlan MG, Group SS (2005) Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial. Transfusion 45(12):1864–1875. doi:10.1111/j.1537-2995.2005.00639.x CrossRefPubMed Snyder E, McCullough J, Slichter SJ, Strauss RG, Lopez-Plaza I, Lin JS, Corash L, Conlan MG, Group SS (2005) Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial. Transfusion 45(12):1864–1875. doi:10.​1111/​j.​1537-2995.​2005.​00639.​x CrossRefPubMed
83.
go back to reference Corash L, Benjamin RJ (2016) The role of hemovigilance and postmarketing studies when introducing innovation into transfusion medicine practice: the amotosalen-ultraviolet A pathogen reduction treatment model. Transfusion 56(Suppl 1):S29–S38. doi:10.1111/trf.13530 CrossRefPubMed Corash L, Benjamin RJ (2016) The role of hemovigilance and postmarketing studies when introducing innovation into transfusion medicine practice: the amotosalen-ultraviolet A pathogen reduction treatment model. Transfusion 56(Suppl 1):S29–S38. doi:10.​1111/​trf.​13530 CrossRefPubMed
85.
go back to reference Laughhunn A, Santa Maria F, Broult J, Lanteri MC, Stassinopoulos A, Musso D, Aubry M (2017) Amustaline (S-303) treatment inactivates high levels of Zika virus in red blood cell components. Transfusion. doi:10.1111/trf.13993 Laughhunn A, Santa Maria F, Broult J, Lanteri MC, Stassinopoulos A, Musso D, Aubry M (2017) Amustaline (S-303) treatment inactivates high levels of Zika virus in red blood cell components. Transfusion. doi:10.​1111/​trf.​13993
86.
go back to reference Winter KM, Johnson L, Kwok M, Vidovic D, Hyland RA, Mufti N, Erickson A, Marks DC (2014) Red blood cell in vitro quality and function is maintained after S-303 pathogen inactivation treatment. Transfusion 54(7):1798–1807. doi:10.1111/trf.12545 CrossRefPubMed Winter KM, Johnson L, Kwok M, Vidovic D, Hyland RA, Mufti N, Erickson A, Marks DC (2014) Red blood cell in vitro quality and function is maintained after S-303 pathogen inactivation treatment. Transfusion 54(7):1798–1807. doi:10.​1111/​trf.​12545 CrossRefPubMed
87.
go back to reference Cancelas JA, Gottschall JL, Rugg N, Graminske S, Schott MA, North A, Huang N, Mufti N, Erickson A, Rico S, Corash L (2017) Red blood cell concentrates treated with the amustaline (S-303) pathogen reduction system and stored for 35 days retain post-transfusion viability: results of a two-centre study. Vox Sang. doi:10.1111/vox.12500 Cancelas JA, Gottschall JL, Rugg N, Graminske S, Schott MA, North A, Huang N, Mufti N, Erickson A, Rico S, Corash L (2017) Red blood cell concentrates treated with the amustaline (S-303) pathogen reduction system and stored for 35 days retain post-transfusion viability: results of a two-centre study. Vox Sang. doi:10.​1111/​vox.​12500
88.
go back to reference Abonnenc M, Sonego G, Crettaz D, Aliotta A, Prudent M, Tissot JD, Lion N (2015) In vitro study of platelet function confirms the contribution of the ultraviolet B (UVB) radiation in the lesions observed in riboflavin/UVB-treated platelet concentrates. Transfusion 55(9):2219–2230. doi:10.1111/trf.13123 CrossRefPubMed Abonnenc M, Sonego G, Crettaz D, Aliotta A, Prudent M, Tissot JD, Lion N (2015) In vitro study of platelet function confirms the contribution of the ultraviolet B (UVB) radiation in the lesions observed in riboflavin/UVB-treated platelet concentrates. Transfusion 55(9):2219–2230. doi:10.​1111/​trf.​13123 CrossRefPubMed
89.
go back to reference Faddy HM, Fryk JJ, Prow NA, Watterson D, Young PR, Hall RA, Tolksdorf F, Sumian C, Gravemann U, Seltsam A, Marks DC (2016) Inactivation of dengue, chikungunya, and Ross River viruses in platelet concentrates after treatment with ultraviolet C light. Transfusion 56(6 Pt 2):1548–1555. doi:10.1111/trf.13519 CrossRefPubMed Faddy HM, Fryk JJ, Prow NA, Watterson D, Young PR, Hall RA, Tolksdorf F, Sumian C, Gravemann U, Seltsam A, Marks DC (2016) Inactivation of dengue, chikungunya, and Ross River viruses in platelet concentrates after treatment with ultraviolet C light. Transfusion 56(6 Pt 2):1548–1555. doi:10.​1111/​trf.​13519 CrossRefPubMed
90.
go back to reference Cap AP, Pidcoke HF, Keil SD, Staples HM, Anantpadma M, Carrion R Jr, Davey RA, Frazer-Abel A, Taylor AL, Gonzales R, Patterson JL, Goodrich RP (2016) Treatment of blood with a pathogen reduction technology using ultraviolet light and riboflavin inactivates Ebola virus in vitro. Transfusion 56(Suppl 1):S6–15. doi:10.1111/trf.13393 CrossRefPubMed Cap AP, Pidcoke HF, Keil SD, Staples HM, Anantpadma M, Carrion R Jr, Davey RA, Frazer-Abel A, Taylor AL, Gonzales R, Patterson JL, Goodrich RP (2016) Treatment of blood with a pathogen reduction technology using ultraviolet light and riboflavin inactivates Ebola virus in vitro. Transfusion 56(Suppl 1):S6–15. doi:10.​1111/​trf.​13393 CrossRefPubMed
93.
go back to reference Hellstern P, Sachse H, Schwinn H, Oberfrank K (1992) Manufacture and in vitro characterization of a solvent/detergent-treated human plasma. Vox Sang 63(3):178–185CrossRefPubMed Hellstern P, Sachse H, Schwinn H, Oberfrank K (1992) Manufacture and in vitro characterization of a solvent/detergent-treated human plasma. Vox Sang 63(3):178–185CrossRefPubMed
95.
go back to reference Horowitz B, Bonomo R, Prince AM, Chin SN, Brotman B, Shulman RW (1992) Solvent/detergent-treated plasma: a virus-inactivated substitute for fresh frozen plasma. Blood 79(3):826–831PubMed Horowitz B, Bonomo R, Prince AM, Chin SN, Brotman B, Shulman RW (1992) Solvent/detergent-treated plasma: a virus-inactivated substitute for fresh frozen plasma. Blood 79(3):826–831PubMed
96.
go back to reference Prince AM, Horowitz B, Brotman B (1986) Sterilisation of hepatitis and HTLV-III viruses by exposure to tri(n-butyl)phosphate and sodium cholate. Lancet 1(8483):706–710CrossRefPubMed Prince AM, Horowitz B, Brotman B (1986) Sterilisation of hepatitis and HTLV-III viruses by exposure to tri(n-butyl)phosphate and sodium cholate. Lancet 1(8483):706–710CrossRefPubMed
97.
go back to reference Lindholm PF, Annen K, Ramsey G (2011) Approaches to minimize infection risk in blood banking and transfusion practice. Infect Disord Drug Targets 11(1):45–56CrossRefPubMed Lindholm PF, Annen K, Ramsey G (2011) Approaches to minimize infection risk in blood banking and transfusion practice. Infect Disord Drug Targets 11(1):45–56CrossRefPubMed
99.
go back to reference Lescoutra-Etchegaray N, Jaffre N, Sumian C, Durand V, Correia E, Mikol J, Luccantoni-Freire S, Culeux A, Deslys JP, Comoy EE (2015) Evaluation of the protection of primates transfused with variant Creutzfeldt-Jakob disease-infected blood products filtered with prion removal devices: a 5-year update. Transfusion. doi:10.1111/trf.12999 Lescoutra-Etchegaray N, Jaffre N, Sumian C, Durand V, Correia E, Mikol J, Luccantoni-Freire S, Culeux A, Deslys JP, Comoy EE (2015) Evaluation of the protection of primates transfused with variant Creutzfeldt-Jakob disease-infected blood products filtered with prion removal devices: a 5-year update. Transfusion. doi:10.​1111/​trf.​12999
100.
101.
102.
go back to reference Bougard D, Brandel JP, Belondrade M, Beringue V, Segarra C, Fleury H, Laplanche JL, Mayran C, Nicot S, Green A, Welaratne A, Narbey D, Fournier-Wirth C, Knight R, Will R, Tiberghien P, Haik S, Coste J (2016) Detection of prions in the plasma of presymptomatic and symptomatic patients with variant Creutzfeldt-Jakob disease. Sci Transl med 8(370):370ra182. doi:10.1126/scitranslmed.aag1257 CrossRefPubMed Bougard D, Brandel JP, Belondrade M, Beringue V, Segarra C, Fleury H, Laplanche JL, Mayran C, Nicot S, Green A, Welaratne A, Narbey D, Fournier-Wirth C, Knight R, Will R, Tiberghien P, Haik S, Coste J (2016) Detection of prions in the plasma of presymptomatic and symptomatic patients with variant Creutzfeldt-Jakob disease. Sci Transl med 8(370):370ra182. doi:10.​1126/​scitranslmed.​aag1257 CrossRefPubMed
105.
go back to reference Peyvandi F, Mannucci PM, Garagiola I, El-Beshlawy A, Elalfy M, Ramanan V, Eshghi P, Hanagavadi S, Varadarajan R, Karimi M, Manglani MV, Ross C, Young G, Seth T, Apte S, Nayak DM, Santagostino E, Mancuso ME, Sandoval Gonzalez AC, Mahlangu JN, Bonanad Boix S, Cerqueira M, Ewing NP, Male C, Owaidah T, Soto Arellano V, Kobrinsky NL, Majumdar S, Perez Garrido R, Sachdeva A, Simpson M, Thomas M, Zanon E, Antmen B, Kavakli K, Manco-Johnson MJ, Martinez M, Marzouka E, Mazzucconi MG, Neme D, Palomo Bravo A, Paredes Aguilera R, Prezotti A, Schmitt K, Wicklund BM, Zulfikar B, Rosendaal FR (2016) A randomized trial of factor VIII and neutralizing antibodies in hemophilia a. N Engl J med 374(21):2054–2064. doi:10.1056/NEJMoa1516437 CrossRefPubMed Peyvandi F, Mannucci PM, Garagiola I, El-Beshlawy A, Elalfy M, Ramanan V, Eshghi P, Hanagavadi S, Varadarajan R, Karimi M, Manglani MV, Ross C, Young G, Seth T, Apte S, Nayak DM, Santagostino E, Mancuso ME, Sandoval Gonzalez AC, Mahlangu JN, Bonanad Boix S, Cerqueira M, Ewing NP, Male C, Owaidah T, Soto Arellano V, Kobrinsky NL, Majumdar S, Perez Garrido R, Sachdeva A, Simpson M, Thomas M, Zanon E, Antmen B, Kavakli K, Manco-Johnson MJ, Martinez M, Marzouka E, Mazzucconi MG, Neme D, Palomo Bravo A, Paredes Aguilera R, Prezotti A, Schmitt K, Wicklund BM, Zulfikar B, Rosendaal FR (2016) A randomized trial of factor VIII and neutralizing antibodies in hemophilia a. N Engl J med 374(21):2054–2064. doi:10.​1056/​NEJMoa1516437 CrossRefPubMed
106.
go back to reference Hashemi SM, Other J, Another C (2015) Risk for inhibitor development in severe hemophilia A is not associated with FVIII product class or with high von-Willebrand content—oral presentation at ISTH 2015 Hashemi SM, Other J, Another C (2015) Risk for inhibitor development in severe hemophilia A is not associated with FVIII product class or with high von-Willebrand content—oral presentation at ISTH 2015
107.
go back to reference Gouw SC, van der Bom JG, Ljung R, Escuriola C, Cid AR, Claeyssens-Donadel S, van Geet C, Kenet G, Makipernaa A, Molinari AC, Muntean W, Kobelt R, Rivard G, Santagostino E, Thomas A, van den Berg HM, PedNet, Group RS (2013) Factor VIII products and inhibitor development in severe hemophilia A. N Engl J med 368(3):231–239. doi:10.1056/NEJMoa1208024 CrossRefPubMed Gouw SC, van der Bom JG, Ljung R, Escuriola C, Cid AR, Claeyssens-Donadel S, van Geet C, Kenet G, Makipernaa A, Molinari AC, Muntean W, Kobelt R, Rivard G, Santagostino E, Thomas A, van den Berg HM, PedNet, Group RS (2013) Factor VIII products and inhibitor development in severe hemophilia A. N Engl J med 368(3):231–239. doi:10.​1056/​NEJMoa1208024 CrossRefPubMed
108.
go back to reference Piquet Y, Janvier G, Selosse P, Doutremepuich C, Jouneau J, Nicolle G, Platel D, Vezon G (1992) Virus inactivation of fresh frozen plasma by a solvent detergent procedure: biological results. Vox Sang 63(4):251–256CrossRefPubMed Piquet Y, Janvier G, Selosse P, Doutremepuich C, Jouneau J, Nicolle G, Platel D, Vezon G (1992) Virus inactivation of fresh frozen plasma by a solvent detergent procedure: biological results. Vox Sang 63(4):251–256CrossRefPubMed
109.
go back to reference Atance R, Pereira A, Ramirez B (2001) Transfusing methylene blue-photoinactivated plasma instead of FFP is associated with an increased demand for plasma and cryoprecipitate. Transfusion 41(12):1548–1552CrossRefPubMed Atance R, Pereira A, Ramirez B (2001) Transfusing methylene blue-photoinactivated plasma instead of FFP is associated with an increased demand for plasma and cryoprecipitate. Transfusion 41(12):1548–1552CrossRefPubMed
110.
go back to reference Barz D (1994) Detection of antigen structures in blood cells in various prepared plasma transfusions. Anaesthesiol Reanim 19(6):155–158PubMed Barz D (1994) Detection of antigen structures in blood cells in various prepared plasma transfusions. Anaesthesiol Reanim 19(6):155–158PubMed
111.
go back to reference Dewachter P, Castro S, Nicaise-Roland P, Chollet-Martin S, Le Beller C, Lillo-le-Louet A, Mouton-Faivre C (2011) Anaphylactic reaction after methylene blue-treated plasma transfusion. Br J Anaesth 106(5):687–689. doi:10.1093/bja/aer009 CrossRefPubMed Dewachter P, Castro S, Nicaise-Roland P, Chollet-Martin S, Le Beller C, Lillo-le-Louet A, Mouton-Faivre C (2011) Anaphylactic reaction after methylene blue-treated plasma transfusion. Br J Anaesth 106(5):687–689. doi:10.​1093/​bja/​aer009 CrossRefPubMed
113.
go back to reference Yarranton H, Cohen H, Pavord SR, Benjamin S, Hagger D, Machin SJ (2003) Venous thromboembolism associated with the management of acute thrombotic thrombocytopenic purpura. Br J Haematol 121(5):778–785CrossRefPubMed Yarranton H, Cohen H, Pavord SR, Benjamin S, Hagger D, Machin SJ (2003) Venous thromboembolism associated with the management of acute thrombotic thrombocytopenic purpura. Br J Haematol 121(5):778–785CrossRefPubMed
114.
go back to reference Franchini M, Coppola A, Rocino A, Zanon E, Morfini M, Italian Association of Haemophilia Centers AWG, Accorsi A, Aru AB, Biasoli C, Cantori I, Castaman G, Cesaro S, Ciabatta C, De Cristofaro R, Delios G, Di Minno G, D’Inca M, Dragani A, Ettorre CP, Gagliano F, Gamba G, Gandini G, Giordano P, Giuffrida G, Gresele P, Latella C, Luciani M, Margaglione M, Marietta M, Mazzucconi MG, Messina M, Molinari AC, Notarangelo LD, Oliovecchio E, Peyvandi F, Piseddu G, Rossetti G, Rossi V, Santagostino E, Schiavoni M, Schinco P, Serino ML, Tagliaferri A, Testa S (2014) Perceived challenges and attitudes to regimen and product selection from Italian haemophilia treaters: the 2013 AICE survey. Haemophilia 20(2):e128–e135. doi:10.1111/hae.12334 CrossRefPubMed Franchini M, Coppola A, Rocino A, Zanon E, Morfini M, Italian Association of Haemophilia Centers AWG, Accorsi A, Aru AB, Biasoli C, Cantori I, Castaman G, Cesaro S, Ciabatta C, De Cristofaro R, Delios G, Di Minno G, D’Inca M, Dragani A, Ettorre CP, Gagliano F, Gamba G, Gandini G, Giordano P, Giuffrida G, Gresele P, Latella C, Luciani M, Margaglione M, Marietta M, Mazzucconi MG, Messina M, Molinari AC, Notarangelo LD, Oliovecchio E, Peyvandi F, Piseddu G, Rossetti G, Rossi V, Santagostino E, Schiavoni M, Schinco P, Serino ML, Tagliaferri A, Testa S (2014) Perceived challenges and attitudes to regimen and product selection from Italian haemophilia treaters: the 2013 AICE survey. Haemophilia 20(2):e128–e135. doi:10.​1111/​hae.​12334 CrossRefPubMed
117.
go back to reference Liumbruno GM, Calteri D, Petropulacos K, Mattivi A, Po C, Macini P, Tomasini I, Zucchelli P, Silvestri AR, Sambri V, Pupella S, Catalano L, Piccinini V, Calizzani G, Grazzini G (2008) The chikungunya epidemic in Italy and its repercussion on the blood system. Blood Transfus 6(4):199–210PubMedPubMedCentral Liumbruno GM, Calteri D, Petropulacos K, Mattivi A, Po C, Macini P, Tomasini I, Zucchelli P, Silvestri AR, Sambri V, Pupella S, Catalano L, Piccinini V, Calizzani G, Grazzini G (2008) The chikungunya epidemic in Italy and its repercussion on the blood system. Blood Transfus 6(4):199–210PubMedPubMedCentral
118.
go back to reference Pealer LN, Marfin AA, Petersen LR, Lanciotti RS, Page PL, Stramer SL, Stobierski MG, Signs K, Newman B, Kapoor H, Goodman JL, Chamberland ME, West Nile Virus Transmission Investigation T (2003) Transmission of West Nile virus through blood transfusion in the United States in 2002. N Engl J med 349(13):1236–1245. doi:10.1056/NEJMoa030969 CrossRefPubMed Pealer LN, Marfin AA, Petersen LR, Lanciotti RS, Page PL, Stramer SL, Stobierski MG, Signs K, Newman B, Kapoor H, Goodman JL, Chamberland ME, West Nile Virus Transmission Investigation T (2003) Transmission of West Nile virus through blood transfusion in the United States in 2002. N Engl J med 349(13):1236–1245. doi:10.​1056/​NEJMoa030969 CrossRefPubMed
119.
go back to reference Macciocchi D, Lanini S, Vairo F, Zumla A, Figueiredo LT, Lauria FN, Strada G, Brouqui P, Puro V, Krishna S, Kremsner P, Scognamiglio P, Kohler C, Nicastri E, Di Caro A, Cieri RM, Ioannidis JP, Kobinger G, Burattini MN, Ippolito G (2016) Short-term economic impact of the Zika virus outbreak. New Microbiol 39(4):287–289PubMed Macciocchi D, Lanini S, Vairo F, Zumla A, Figueiredo LT, Lauria FN, Strada G, Brouqui P, Puro V, Krishna S, Kremsner P, Scognamiglio P, Kohler C, Nicastri E, Di Caro A, Cieri RM, Ioannidis JP, Kobinger G, Burattini MN, Ippolito G (2016) Short-term economic impact of the Zika virus outbreak. New Microbiol 39(4):287–289PubMed
120.
go back to reference Lozano M, Knutson F, Tardivel R, Cid J, Maymo RM, Lof H, Roddie H, Pelly J, Docherty A, Sherman C, Lin L, Propst M, Corash L, Prowse C (2011) A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and ultraviolet A pathogen inactivation stored for 6 or 7 d prior to transfusion. Br J Haematol 153(3):393–401. doi:10.1111/j.1365-2141.2011.08635.x CrossRefPubMed Lozano M, Knutson F, Tardivel R, Cid J, Maymo RM, Lof H, Roddie H, Pelly J, Docherty A, Sherman C, Lin L, Propst M, Corash L, Prowse C (2011) A multi-centre study of therapeutic efficacy and safety of platelet components treated with amotosalen and ultraviolet A pathogen inactivation stored for 6 or 7 d prior to transfusion. Br J Haematol 153(3):393–401. doi:10.​1111/​j.​1365-2141.​2011.​08635.​x CrossRefPubMed
123.
go back to reference Girona-Llobera E, Jimenez-Marco T, Galmes-Trueba A, Muncunill J, Serret C, Serra N, Sedeno M (2014) Reducing the financial impact of pathogen inactivation technology for platelet components: our experience. Transfusion 54(1):158–168. doi:10.1111/trf.12232 CrossRefPubMed Girona-Llobera E, Jimenez-Marco T, Galmes-Trueba A, Muncunill J, Serret C, Serra N, Sedeno M (2014) Reducing the financial impact of pathogen inactivation technology for platelet components: our experience. Transfusion 54(1):158–168. doi:10.​1111/​trf.​12232 CrossRefPubMed
126.
go back to reference McCullough J, Goldfinger D, Gorlin J, Riley WJ, Sandhu H, Stowell C, Ward D, Clay M, Pulkrabek S, Chrebtow V, Stassinopoulos A (2015) Cost implications of implementation of pathogen-inactivated platelets. Transfusion 55(10):2312–2320. doi:10.1111/trf.13149 CrossRefPubMedPubMedCentral McCullough J, Goldfinger D, Gorlin J, Riley WJ, Sandhu H, Stowell C, Ward D, Clay M, Pulkrabek S, Chrebtow V, Stassinopoulos A (2015) Cost implications of implementation of pathogen-inactivated platelets. Transfusion 55(10):2312–2320. doi:10.​1111/​trf.​13149 CrossRefPubMedPubMedCentral
127.
go back to reference Kwon SY, Kim IS, Bae JE, Kang JW, Cho YJ, Cho NS, Lee SW (2014) Pathogen inactivation efficacy of Mirasol PRT system and intercept blood system for non-leucoreduced platelet-rich plasma-derived platelets suspended in plasma. Vox Sang 107(3):254–260. doi:10.1111/vox.12158 CrossRefPubMed Kwon SY, Kim IS, Bae JE, Kang JW, Cho YJ, Cho NS, Lee SW (2014) Pathogen inactivation efficacy of Mirasol PRT system and intercept blood system for non-leucoreduced platelet-rich plasma-derived platelets suspended in plasma. Vox Sang 107(3):254–260. doi:10.​1111/​vox.​12158 CrossRefPubMed
131.
go back to reference Smit AK, Keogh LA, Hersch J, Newson AJ, Butow P, Williams G, Cust AE (2016) Public preferences for communicating personal genomic risk information: a focus group study. Health Expect 19(6):1203–1214. doi:10.1111/hex.12406 CrossRefPubMed Smit AK, Keogh LA, Hersch J, Newson AJ, Butow P, Williams G, Cust AE (2016) Public preferences for communicating personal genomic risk information: a focus group study. Health Expect 19(6):1203–1214. doi:10.​1111/​hex.​12406 CrossRefPubMed
133.
go back to reference Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Munoz M, Gombotz H, Weber CF, Choorapoikayil S, Spahn DR, Zacharowski K (2016) Patient blood management bundles to facilitate implementation. Transfus med rev. doi:10.1016/j.tmrv.2016.05.012 Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Munoz M, Gombotz H, Weber CF, Choorapoikayil S, Spahn DR, Zacharowski K (2016) Patient blood management bundles to facilitate implementation. Transfus med rev. doi:10.​1016/​j.​tmrv.​2016.​05.​012
134.
go back to reference Srivastava A, Brewer AK, Mauser-Bunschoten EP, Key NS, Kitchen S, Llinas A, Ludlam CA, Mahlangu JN, Mulder K, Poon MC, Street A, Treatment Guidelines Working Group on Behalf of The World Federation Of H (2013) Guidelines for the management of hemophilia. Haemophilia 19(1):e1–47. doi:10.1111/j.1365-2516.2012.02909.x CrossRefPubMed Srivastava A, Brewer AK, Mauser-Bunschoten EP, Key NS, Kitchen S, Llinas A, Ludlam CA, Mahlangu JN, Mulder K, Poon MC, Street A, Treatment Guidelines Working Group on Behalf of The World Federation Of H (2013) Guidelines for the management of hemophilia. Haemophilia 19(1):e1–47. doi:10.​1111/​j.​1365-2516.​2012.​02909.​x CrossRefPubMed
136.
go back to reference Rocino A, Coppola A, Franchini M, Castaman G, Santoro C, Zanon E, Santagostino E, Morfini M, Italian Association of Haemophilia Centres Working P (2014) Principles of treatment and update of recommendations for the management of haemophilia and congenital bleeding disorders in Italy. Blood Transfus 12(4):575–598. doi:10.2450/2014.0223-14 PubMedPubMedCentral Rocino A, Coppola A, Franchini M, Castaman G, Santoro C, Zanon E, Santagostino E, Morfini M, Italian Association of Haemophilia Centres Working P (2014) Principles of treatment and update of recommendations for the management of haemophilia and congenital bleeding disorders in Italy. Blood Transfus 12(4):575–598. doi:10.​2450/​2014.​0223-14 PubMedPubMedCentral
137.
139.
go back to reference Hospital SEU (2015) Informed consent form for transfusion Hospital SEU (2015) Informed consent form for transfusion
140.
go back to reference Friedman M, Arja W, Batra R, Daniel S, Hoehn D, Paniz AM, Selegean S, Slova D, Srivastava S, Vergara N (2012) Informed consent for blood transfusion: what do medicine residents tell? What do patients understand? Am J Clin Pathol 138(4):559–565. doi:10.1309/AJCP2TN5ODJLYGQR CrossRefPubMed Friedman M, Arja W, Batra R, Daniel S, Hoehn D, Paniz AM, Selegean S, Slova D, Srivastava S, Vergara N (2012) Informed consent for blood transfusion: what do medicine residents tell? What do patients understand? Am J Clin Pathol 138(4):559–565. doi:10.​1309/​AJCP2TN5ODJLYGQR​ CrossRefPubMed
142.
go back to reference Vossoughi SR, Macauley R, Sazama K, Fung MK (2015) Attitudes, practices, and training on informed consent for transfusions and procedures: a survey of medical students and physicians. Am J Clin Pathol 144(2):315–321. doi:10.1309/AJCPP85EXSGZORYZ CrossRefPubMed Vossoughi SR, Macauley R, Sazama K, Fung MK (2015) Attitudes, practices, and training on informed consent for transfusions and procedures: a survey of medical students and physicians. Am J Clin Pathol 144(2):315–321. doi:10.​1309/​AJCPP85EXSGZORYZ​ CrossRefPubMed
Metadata
Title
Pathogen reduction/inactivation of products for the treatment of bleeding disorders: what are the processes and what should we say to patients?
Authors
Giovanni Di Minno
David Navarro
Carlo Federico Perno
Mariana Canaro
Lutz Gürtler
James W. Ironside
Hermann Eichler
Andreas Tiede
Publication date
01-08-2017
Publisher
Springer Berlin Heidelberg
Published in
Annals of Hematology / Issue 8/2017
Print ISSN: 0939-5555
Electronic ISSN: 1432-0584
DOI
https://doi.org/10.1007/s00277-017-3028-4

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