Solvent/detergent-treated plasma: a tale of 30 years of experience

References

• Horowitz B, Wiebe ME, Lippin A, Stryer MH. Inactivation of viruses in labile blood derivatives: disruption of lipid-enveloped viruses by tri(n-butyl)phosphate detergent combinations. Transfusion 1985;25:516-22
   PubMed Web of Science ®Google Scholar
• Prince AM, Horowitz B, Brotman B. Sterilization of hepatitis and HTLV-III viruses by exposure to tri(n-butyl)phosphate and sodium cholate. Lancet 1986;1:706-10
   Google Scholar
• Dichtelmüller HO, Biesert L, Fabbrizzi F, et al. Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Therapeutics Association member companies. Transfusion 2009;49:1931-43
   Google Scholar
• Mayr WR. Haemovigilance: are there significant differences among plasma products? Transfus Apher Sci 2010;43:407-9
   Google Scholar
• Bost V, Odent-Malaure H, Chavarin P, et al. A regional haemovigilance retrospective study of four types of therapeutic plasma in a ten-year survey period in France. Vox Sang 2013;104:337-41
   PubMed Web of Science ®Google Scholar
• Neurath AR, Vernon SK, Dobkin MB, Rubin BA. Characterization of subviral components resulting from treatment of rabies virus with tri(n-butyl) phosphate. J Gen Virol 1972;14:33-48
   Google Scholar
• Omenn GS. Data management and data integration in the HUPO plasma proteome project. Methods Mol Biol 2011;696:247-57
   PubMedGoogle Scholar
• Horowitz B, Bonomo R, Prince AM, et al. Solvent/detergent-treated plasma. A virus-inactivated substitute for fresh frozen plasma. Blood 1992;79:826-33
   PubMed Web of Science ®Google Scholar
• Hellstern P, Sachse H, Schwinn H, Oberfrank K. Manufacture and in-vitro characterization of solvent/detergent-treated plasma. Vox Sang 1992;63:178-85
   PubMed Web of Science ®Google Scholar
• Hellstern P, Solheim BG. The use of solvent/detergent treatment in pathogen reduction of plasma. Transfus Med Hemother 2011;38:65-70
   PubMed Web of Science ®Google Scholar
• Biesert L, Shartono H. Solvent/detergent treatment of human plasma: a very robust method for virus inactivation. Validation of virus safety of Octaplas. Vox Sang 1998;74:207-12
   Google Scholar
• Prowse C. Properties of pathogen-inactivated plasma components. Transfus Med Rev 2009;23:124-33
   Google Scholar
• Heger A, Svae TE, Neisser-Svae A, et al. Biochemical quality of the pharmaceutically licensed plasma OctaplasLG after implementation of a novel prion protein (PrPSc) removal technology and reduction of the solvent/detergent (S/D) process time. Vox Sang 2009;97:219-25
   Google Scholar
• Jilma-Stohlawetz P, Kursten FW, Horvath M, et al. Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers. Transfusion 2013;53:1906-17
   Google Scholar
• Liumbruno GM, Catalano L, Piccinini V, et al. Reduction of the risk of bacterial contamination of blood components through diversion of the first part of the donation of blood and blood components. Blood Transfus 2009;7:86-93
   Google Scholar
• Chou ML, Wu YW, Su CY, et al. Impact of solvent/detergent treatment of plasma on transfusion-relevant bacteria. Vox Sang 2012;102:277-84
   Google Scholar
• Leydold SM, Farcet MR, Kindermann J, et al. Chikungunya virus and the safety of plasma products. Transfusion 2012;52:2122-30
   Web of Science ®Google Scholar
• Solheim BG, Rollag H, Svennevig JL, et al. Viral safety of solvent/detergent-treated plasma. Transfusion 2000;40:84-90
   PubMedGoogle Scholar
• Marano G, Vaglio S, Pupella S, et al. Human Parvovirus B19 and blood product safety: a tale of twenty years of improvements. Blood Transfus 2014. [Epub ahead of print]
   Google Scholar
• Liumbruno GM, Sodini ML, Grazzini G. Tuscan transfusion system. recommendations from the Tuscan transfusion system on the appropriate use of solvent/detergent-inactivated fresh-frozen plasma. Blood Transfus 2008;6:25-36
   Google Scholar
• Pelletier JP, Transue S, Snyder EL. Pathogen inactivation techniques. Best Pract Res Clin Haematol 2006;19:205-42
   PubMed Web of Science ®Google Scholar
• Koenigbauer UF, Eastlund T, Day JW. Clinical illness due to parvovirus B19 infection after infusion of solvent/detergent-treated pooled plasma. Transfusion 2000;40:1203-6
   Google Scholar
• Marano G, Vaglio S, Pupella S, et al. Hepatitis E: an old infection with new implications. Blood Transfus 2015;13(1):6-20
   Google Scholar
• Grazzini G, Rossi G, Rafanelli D, et al. Quality control of recovered plasma for fractionation: an extensive Italian study. Transfusion 2008;48:1459-68
   Google Scholar
• Hellstern P. Solvent/detergent-treated plasma: composition, efficacy, and safety. Curr Opin Hematol 2004;11:346-50
   Web of Science ®Google Scholar
• Magner JJ, Crowley KJ, Boylan JF. Fatal fibrinolysis during orthotopic liver transplantation in patients receiving solvent/detergent-treated plasma (Octaplas). J Cardiothorac Vasc Anesth 2007;21:410-13
   Google Scholar
• Sandler SG. It is time to bring back solvent-detergent plasma. Curr Opin Hematol 2007;14:640-1
   Google Scholar
• Salge-Bartels U, Breitner-Ruddock S, Hunfeld A, et al. Are quality differences responsible for different adverse reactions reported for SD-plasma from USA and Europe? Transfus Med 2006;16:266-75
   Google Scholar
• Flamholz R, Jeon HR, Baron JM, Baron BW. Study of three patients with thrombotic thrombocytopenic purpura exchanged with solvent/detergent-treated plasma: is its decreased protein S activity clinically related to their development of deep venous thromboses? J Clin Apher 2000;15:169-72
   Google Scholar
• Yarranton H, Cohen H, Pavord SR, et al. Venous thromboembolism associated with the management of acute thrombotic thrombocytopenic purpura. Br J Haematol 2003;121:778-85
   PubMed Web of Science ®Google Scholar
• McMinn JRJr, Thomas IA, Terrel DR, et al. Complications of plasma exchange in thrombotic thrombocytopenic purpura - hemolytic uremic syndrome: a study of 78 additional patients. Transfusion 2003;43:415-16
   Google Scholar
• Blood products advisory committee. Pooled Plasma (Human), Solvent/Detergent Treated (Octaplas™) BLA 125416/0 For BPAC Meeting. September 20 2012. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM319772.pdf
   Google Scholar
• Heger A, Kannicht C, Römisch J, Svae TE. Normal levels of ADAMTS13 and factor H are present in the pharmaceutically licensed plasma for transfusion (Octaplas®) and in the universally applicable plasma (Uniplas) in development. Vox Sang 2007;92:206-12
   PubMedGoogle Scholar
• Sharma AD, Sreeram D, Erb T, Grocott HP. Solvent-detergent fresh frozen plasma. A superior alternative to standard fresh frozen plasma? J Cardiothorac Vasc Anesth 2000;14:712-17
   Google Scholar
• Solheim BG, Seghatchian J. Update on pathogen reduction technology for therapeutic plasma: an overview. Transfus Apher Sci 2006;35:83-90
   Web of Science ®Google Scholar
• Sinnott P, Bodger S, Gupta A, Brophy M. Presence of HLA antibodies in single-donor-derived fresh frozen plasma compared with pooled, solvent detergent-treated plasma (Octaplas). Eur J Immunogenet 2004;31:271-4
   Google Scholar
• Sachs UJ, Kauschat D, Bein G. White blood cell reactive antibodies are undetectable in solvent/detergent plasma. Transfusion 2005;45:1628-31
   PubMed Web of Science ®Google Scholar
• Steinsvåg CT, Espinosa A, Flesland O. Eight years with haemovigilance in Norway. What have we learnt? Transfus Apher Sci 2013;49:548-52
   Google Scholar
• Horowitz MS, Pehta JC. SD plasma in TTP and coagulation factor deficiencies for which no cxoncentrates are available. Vox Sang 1998;74(Suppl 1):231-5
   Google Scholar
• Freeman JW, Williamson LM, Llewelyn C, et al. A randomized trial of solvent/detergent and standard fresh frozen plasma in the treatment of the coagulopathy seen during orthotopic liver transplantation. Vox Sang 1998;74:225-9
   Google Scholar
• Williamson LM, Llewelyn CA, Fisher NC, et al. A randomized trial of solvent/detergent-treated and standard fresh-frozen plasma in the coagulopathy of liver disease and liver transplantation. Transfusion 1999;39:1227-34
   Google Scholar
• Beck KH, Mortelsmans Y, Kretschmer VV, et al. Comparison of solvent/detergent-inactivated plasma and fresh frozen plasma under routine clinical conditions. Infusionsther Transfusionsmed 2000;27:144-8
   Google Scholar
• Lerner RG, Nelson J, Sorcia E. Evaluation of solvent/detergent treated plasma in patients with a prolonged prothrombin time. Vox Sang 2000;79:161-7
   Google Scholar
• Solheim BG, Granov DA, Juravlev VA, et al. Universal fresh-frozen plasma (Uniplas): an exploratory study in adult patients undergoing elective liver resection. Vox Sang 2005;89:19-26
   Google Scholar
• Chekrizova V, Murphy WG. Solvent–detergent plasma: use in neonatal patients, in adult and paediatric patients with liver disease and in obstetric and gynaecological emergencies. Transfus Med 2006;16:85-91
   Google Scholar
• McCarthy LJ. The experience of treating patients with thrombotic thrombocytopenic purpura with solvent detergent plasma. Br J Haematol 2006;133:103-8
   Google Scholar
• Santagostino E, Mancuso ME, Morfini M, et al. Solvent/detergent plasma for prevention of bleeding in recessively inherited coagulation disorders: dosing, pharmacokinetics and clinical efficacy. Haematologica 2006;91:631-9
   Google Scholar
• Scully M, Longair I, Flynn M, et al. Cryosupernatant and solvent detergent fresh frozen plasma (Octaplas) usage in a single centre in acute thrombotic thrombocytopenic purpura. Vox Sang 2007;93:154-8
   PubMed Web of Science ®Google Scholar
• Bindi ML, Miccoli M, Marietta M, et al. Solvent detergent vs. fresh frozen plasma in cirrhotic patients undergoing liver transplant surgery: a prospective randomized control study. Vox Sang 2013;105:137-43
   Google Scholar
• Haubelt H, Blome M, Kiessling AH, et al. Effects of solvent/detergent-treated plasma and fresh-frozen plasma on haemostasis and fibrinolysis in complex coagulopathy following open-heart surgery. Vox Sang 2002;82:9-14
   Google Scholar
• De Jonge J, Groenland THN, Metselaar HJ, et al. Fibrinolysis during liver transplantation is enhanced by using solvent/detergent virus-inactivated plasma (ESDEP®). Anesth Analg 2002;94:1127-31
   Google Scholar
• Solheim BG, Bergan A, Brosstad F, et al. Fibrinolysis during liver transplant and use of Solvent/Detergent Virus Inactivated Plasma (ESDEP/Octaplas). Anesth Analg 2003;96:1230-1
   Google Scholar
• De Jonge J, Groenland THN, Metselaar HJ, et al. Liver transplantation, solvent-detergent treated plasma and antifibrinolytics. Anesth Analg 2003;96:1231-2
   Google Scholar
• Benson AB, Burton JR, Austin GL, et al. Differential effects of plasma and red blood cell transfusions on acute lung injury and infection risk following liver transplantation. Liver Transpl 2011;17:149-58
   PubMed Web of Science ®Google Scholar
• Lepri D, Capuzzo E, Mattioli AV, et al. Clinical use of virally inactived plasma. The experience of blood transfusion unit in Mantova, Italy. Recenti Prog Med 2013;104:106-11
   Google Scholar
• Dudaryk R, Hess AS, Varon AJ, Hess JR. What is new in the blood bank for trauma resuscitation. Curr Opin Anaesthesiol 2014. [Epub ahead of print]
   Google Scholar
• Andreu G. France: Solvent/detergent plasma. In: AuBuchon JP, Prowse CV, editors. Pathogen inactivation: the penultimate paradigm shift. AABB Press; Bethesda: 2010. p. 137-51
   Google Scholar
• Haugaa H, Taraldsrud E, Nyrerød HC, et al. Low incidence of hyperfibrinolysis and thromboembolism in 195 primary liver transplantations transfused with solvent/detergent treated plasma. Clin Med Res 2014;12(1-2):27
   Google Scholar
• Bolton-Maggs PH, Cohen H. Serious hazards of transfusion (SHOT) haemovigilance and progress is improving transfusion safety. Br J Haematol 2013;163:303-14
   PubMed Web of Science ®Google Scholar
• Facco G, Pupella S, Piccinini V, et al. I dati italiani di emovigilanza. Blood Transfus 2012;10:s57-8
   Google Scholar
• Facco G, Piccinini V, Catalano L, et al. Attività di emovigilanza in Italia. Rapporto 2009-2011. Istituto Superiore di Sanità; Roma: 2013; Rapporti ISTISAN 13/21
   Google Scholar
• Liumbruno GM, Franchini M. Solvent/detergent plasma: pharmaceutical characteristics and clinical experience. J Thromb Thrombolysis 2014;39(1):118-28
   Google Scholar
• Hellstern P. Fresh-frozen plasma, pathogen-reduced single-donor plasma or bio-pharmaceutical plasma? Transfus Apheresis Sci 2008;39:69-74
   Google Scholar