Plasma treated with methylene blue and light: Clinical efficacy and safety profile

Transfusion Medicine Reviews

Volumn 27, Issue 4, 2013, Pages 235-240

  Lozano, Miguel ^a   Cid, Joan ^a   Müller, Thomas H ^b  

^a HOSPITAL CLÍNIC   (Spain)

^b Institute Springe   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR; METHYLENE BLUE;

ALLERGIC REACTION; BLOOD SAFETY; FRANCE; HEMOSTASIS; HUMAN; LIGHT; PLASMA; REVIEW; SPAIN; UNITED KINGDOM;

ANTIVIRAL AGENTS; BLOOD SAFETY; BLOOD TRANSFUSION; CALIBRATION; FACTOR VIII; FIBRINOGEN; HEMOSTASIS; HUMANS; HYPERSENSITIVITY; LIGHT; METHYLENE BLUE; PATIENT SAFETY; PLASMA; RISK; THROMBIN;

EID: 84886747685     PISSN: 08877963     EISSN: 15329496     Source Type: Journal    
DOI: 10.1016/j.tmrv.2013.08.001     Document Type: Review

References (51)

1. Lozano M. Pathogen - inactivation technologies for blood components. Blood component preparation: from benchtop to bedside 2011, 247-270. AABB Press, Bethesda, Maryland. M. Blajchman, J. Cid, M. Lozano (Eds.).
2. Tabor E. The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1. Transfusion 1999, 39:1160-1168.
3. Webert K.E., Cserti C.M., Hannon J., Lin Y., Pavenski K., Pendergrast J.M., et al. Proceedings of a Consensus Conference: pathogen inactivation-making decisions about new technologies. Transfus Med Rev 2008, 22:1-34.
4. Klein H.G., Glynn S.A., Ness P.M., Blajchman M.A. Research opportunities for pathogen reduction/inactivation of blood components: summary of an NHLBI workshop. Transfusion 2009, 49:1262-1268.
5. Lambrecht B., Mohr H., Knuver-Hopf J., Schmitt H. Photoinactivation of viruses in human fresh plasma by phenothiazine dyes in combination with visible light. Vox Sang 1991, 60:207-213.
6. Mohr H. Methylene blue and thionine in pathogen inactivation of plasma and platelet concentrates. Transfus Apher Sci 2001, 25:183-184.
7. Zeiler T., Riess H., Wittmann G., Hintz G., Zimmermann R., Muller C., et al. The effect of methylene blue phototreatment on plasma proteins and in vitro coagulation capability of single-donor fresh-frozen plasma. Transfusion 1994, 34:685-689.
8. Aznar J.A., Bonanad S., Montoro J.M., Hurtado C., Cid A.R., Soler M.A., et al. Influence of methylene blue photoinactivation treatment on coagulation factors from fresh frozen plasma, cryoprecipitates and cryosupernatants. Vox Sang 2000, 79:156-160.
9. Cid J., Ramiro L., Martinez N., Palomo M., Magallon O., Claparols M., et al. Quantitative and qualitative analysis of proteins in fresh frozen plasma obtained from whole blood donations and prepared with two photochemical treatments. Transfus Apher Sci 2008, 39:115-121.
10. Williamson L.M., Cardigan R., Prowse C.V. Methylene blue-treated fresh-frozen plasma: what is its contribution to blood safety?. Transfusion 2003, 43:1322-1329.
11. Gravemann U., Kusch M., Koenig H., Mohr H., Mueller T.H. Thrombin generation capacity of methylene blue-treated plasma prepared by the Theraflex MB plasma system. Transfus Med Hemother 2009, 36:122-127.
12. Cardigan R., Philpot K., Cookson P., Luddington R. Thrombin generation and clot formation in methylene blue-treated plasma and cryoprecipitate. Transfusion 2009, 49:696-703.
13. Pock K., Heger A., Janisch S., Svae T.E., Romisch J. Thrombin generation capacity is impaired in methylene-blue treated plasma compared to normal levels in single-donor fresh-frozen plasma, a licensed solvent/detergent-treated plasma (Octaplas) and a development product (Uniplas). Transfus Apher Sci 2007, 37:223-231.
14. Seghatchian J., Walker W.H., Reichenberg S. Updates on pathogen inactivation of plasma using Theraflex methylene blue system. Transfus Apher Sci 2008, 38:271-280.
15. Steinmann E., Gravemann U., Friesland M., Doerrbecker J., Muller T.H., Pietschmann T., et al. Two pathogen reduction technologies-methylene blue plus light and shortwave ultraviolet light-effectively inactivate hepatitis C virus in blood products. Transfusion 2013, 53:1010-1018.
16. Alvarez-Do Barrio M, Villalba Cloquells J, Blanquer Cots A, Puig Alcaraz N, Planelles Silvestre D, Sánchez H, et al. Transmisión de VIH-1 por componentes de una donación en periodo ventana. Libro de ponencias y comunicaciones del 21 Congreso Nacional de la SETS 10 al 12 de junio de 2010 Valladolid P-003, 251.
17. Seghatchian J., Struff W.G., Reichenberg S. Main properties of the Theraflex MB-plasma system for pathogen reduction. Transfus Med Hemother 2011, 38:55-64.
18. Wieding J.U., Neumeyer H. Erste Erfahrungen mit Methylenblau-Virus-inaktiviertem Fresh-Frozen-Plasma: Ergebnisse einer klinischen und einer In-vitro-Studie. Infusionsther Transfusionsmed 1992, 19:84-90.
19. Pohl U., Beyer H.J. Safety and tolerance of methylene blue virus inactivated fresh frozen plasma: the lower Saxony experience 1995, ISBT V Regional Congress, Venice, Italy.
20. Pohl U., Wieding J.U. Treatment of patients with severe congenital coagulation factor V or XI deficiency with methylene blue virus inactivated plasma 1995, ISBT V Regional Congress, Venice, Italy.
21. Pohl U., Becker M. Methylene blue virus inactivated fresh frozen plasma in the treatment of patients with thrombotic thrombocytopenic purpura 1995, ISBT V Regional Congress, Venice, Italy.
22. Pohl U, Mohr H. Experiences in the clinical use of plasma photodynamically virus inactivated by the methylene blue/light procedure. 24th International Congress of the ISBT Tokyo Japan. 1996.
23. Köhler M, Wieding JU, Niehues A, Zenker D, Rathgeber J, Sonntag H, et al. Efficacy and tolerance of methylene blue/light (MB-VIP) versus solvent/detergent virus-inactivated plasma (SD-VIP) in cardiac surgery: clinical results of a prospective, randomized study. 24th Internation Congress of the ISBT Tokyo Japan. 1996.
24. Wieding J.U., Rathgeber J., Zenker D., Pohl U., Koehler M. Prospective, randomized and controlled study solvent/detergent versus methylene blue/light virus inactivated plasma. AABB Annual Meeting. San Francisco, CA. Transfusion 1999, 39(Suppl):23S.
25. Bartelmaos T., Chabanel A., Leger J., Villalon L., Gillon M.C., Rouget C., et al. Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas. Transfusion 2013, 53:1335-1345.
26. Atance R., Pereira A., Ramirez B. Transfusing methylene blue-photoinactivated plasma instead of FFP is associated with an increased demand for plasma and cryoprecipitate. Transfusion 2001, 41:1548-1552.
27. Algora M., Barbolla L. Uses of plasma in Spain. Transfus Clin Biol 2007, 14:564-567.
28. Lozano M., Cid J. Spain: methylene-blue plasma. Pathogen inactivation: The Penultimate Paradigm Shift 2010, 181-188. AABB Press, Bethesda. J.P. AuBuchon, C. Prowse (Eds.).
29. Larrea L., Calabuig M., Soler M.A., Solves P., Mirabet V., Roig R. Our nine years experience in plasma inactivation. 17th ISBT Regional Congress. Madrid. Spain. Vox Sang 2007, 93(Suppl 1):167.
30. de la Rubia J., Arriaga F., Linares D., Larrea L., Carpio N., Marty M.L., et al. Role of methylene blue-treated or fresh-frozen plasma in the response to plasma exchange in patients with thrombotic thrombocytopenic purpura. Br J Haematol 2001, 114:721-723.
31. Alvarez-Larran A., Del Rio J., Ramirez C., Albo C., Pena F., Campos A., et al. Methylene blue-photoinactivated plasma vs. fresh-frozen plasma as replacement fluid for plasma exchange in thrombotic thrombocytopenic purpura. Vox Sang 2004, 86:246-251.
32. del Río Garma J., Pereira A., Arroyo J.L., Mateo J., Alvarez-Larran A., Martinez C., et al. ADAMTS-13 activity and von Willebrand factor levels in methylene-blue photo-inactivated plasma processed by either the Springe method or an 'in house' system. Vox Sang 2008, 95:101-105.
33. Skold A., Cosco D.L., Klein R. Methemoglobinemia: pathogenesis, diagnosis, and management. South Med J 2011, 104:757-761.
34. Ramin S., Azar F.P., Malihe H. Methylene blue as the safest blue dye for sentinel node mapping: emphasis on anaphylaxis reaction. Acta Oncol 2011, 50:729-731.
35. Horwhat J.D., Maydonovitch C.L., Ramos F., Colina R., Gaertner E., Lee H., et al. A randomized comparison of methylene blue-directed biopsy versus conventional four-quadrant biopsy for the detection of intestinal metaplasia and dysplasia in patients with long-segment Barrett's esophagus. Am J Gastroenterol 2008, 103:546-554.
36. Paciullo C.A., McMahon H.D., Hatton K.W., Flynn J.D. Methylene blue for the treatment of septic shock. Pharmacotherapy 2010, 30:702-715.
37. Rodrigues J.M., Pazin Filho A., Rodrigues A.J., Vicente W.V., Evora P.R. Methylene blue for clinical anaphylaxis treatment: a case report. Sao Paulo Med J 2007, 125:60-62.
38. Simonsen A.C., Sorensen H. Clinical tolerance of methylene blue virus-inactivated plasma. A randomized crossover trial in 12 healthy human volunteers. Vox Sang 1999, 77:210-217.
39. Nubret K., Delhoume M., Orsel I., Laudy J.S., Sellami M., Nathan N. Anaphylactic shock to fresh-frozen plasma inactivated with methylene blue. Transfusion 2011, 51:125-128.
40. Dewachter P., Castro S., Nicaise-Roland P., Chollet-Martin S., Le B.C., Lillo-le-Louet A., et al. Anaphylactic reaction after methylene blue-treated plasma transfusion. Br J Anaesth 2011, 106:687-689.
41. Mertes P.M., Demoly P., Alperovitch A., Bazin A., Bienvenu J., Caldani C., et al. Methylene blue-treated plasma: an increased allergy risk?. J Allergy Clin Immunol 2012, 130:808-812.
42. Seltsam A., Mueller T.H. Updated hemovigilance data do not show an increased risk of allergic reaction to methylene blue-treated plasma. J Allergy Clin Immunol 2013, 131:1253-1254.
43. Last accessed August 20, 2013. http://ansm.sante.fr/S-informer/Points-d-information-Points-d-information/L-Afssaps-recommande-l-arret-progressif-de-l-utilisation-du-plasma-therapeutique-traite-par-le-bleu-de-methylene-Point-d-information.
44. Bost V., Odent-Malaure H., Chavarin P., Benamara H., Fabrigli P., Garraud O. A regional haemovigilance retrospective study of four types of therapeutic plasma in a ten-year survey period in France. Vox Sang 2013, 104:337-341.
45. Nussbaumer W., Mayersbach P., Gächter E., Schennach H., Mayer W. Reduced number of adverse events with methylene blue treated plasma compared with quarantine stored plasma: a single center's 3year experience. Vox Sang 2012, 103(Suppl 1):44.
46. New H., Tinegate H., Hunt L., Bolton-Maggs P., Cardigan R. Methylene blue-treated plasma. Joint UKBTS/HPA Professional Advisory Committee/Serious Hazards of Transfusion (SHOT) Position Statement Last accessed August 20, 2013. http://www.transfusionguidelines.org.uk/Index.aspx?pageid=7737§ion=12&publication=D.
47. Politis C., Hantziara S., Zervou E., Parara M., Katsarou O., Fountouli K., et al. Haemovigilance for the use of methylene blue inactivated fresh frozen plasma versus quarantine plasma over the period 2007-2011 in Greece. Transfusion 2012, 52(Supp):174a.
48. Plasmas unitaires viro-inactivés à usage thérapeutique produits par une méthode combinée de déplétion cellulaire et de photo-oxydation par le Bleu de Méthylène Last accessed August 20, 2013. http://www.transfusionbe/documents/feuillet_bm_v041014_v21pdf.
49. Deneys V., Latinne D., Guerrieri C., Baele P. Three years haemovigilance of methylene blue-treated fresh frozen plasma: no increase in transfusion reaction incidence. Vox Sang 2006, 2006:502.
50. Bezu C., Coutant C., Salengro A., Darai E., Rouzier R., Uzan S. Anaphylactic response to blue dye during sentinel lymph node biopsy. Surg Oncol 2011, 20:e55-e59.
51. Dewachter P., Mouton-Faivre C., Trechot P., Lleu J.C., Mertes P.M. Severe anaphylactic shock with methylene blue instillation. Anesth Analg 2005, 101:149-150.