Hemostatic efficacy of pathogen-inactivated vs untreated platelets: A randomized controlled trial

Blood

Volumn 132, Issue 2, 2018, Pages 223-231

  van der Meer, Pieter F ^a   Ypma, Paula F ^a,b   van Geloven, Nan ^c   van Hilten, Joost A ^a   van Wordragen Vlaswinkel, Rinie J ^c   Eissen, Okke ^b   Zwaginga, Jaap J ^c   Trus, Michael ^d   Beckers, Erik A M ^e   te Boekhorst, Peter ^f   Tinmouth, Alan ^g   Lin, Yulia ^h   Hsia, Cyrus ⁱ   Lee, David ^j   Norris, Philip J ^k   Goodrich, Raymond P ^l   Brand, Anneke ^a,c   Hervig, Tor ^m   Heddle, Nancy M ⁿ   van der Bom, Johanna G ^a,c   Kerkhoffs, Jean Louis H ^a,b   more..

^a Center for Clinical Transfusion Reseach Sanquin LUMC   (Netherlands)

^b HAGA HOSPITAL   (Netherlands)

^c LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^d Juravinski Cancer Center   (Canada)

^e MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^f ERASMUS MEDICAL CENTER   (Netherlands)

^g UNIVERSITY OF OTTAWA   (Canada)

^h SUNNYBROOK RESEARCH INSTITUTE   (Canada)

ⁱ LONDON HEALTH SCIENCES CENTRE   (Canada)

^j KINGSTON GENERAL HOSPITAL   (Canada)

^k BLOOD SYSTEMS RESEARCH INSTITUTE   (United States)

^l Veterinary Dentistry and Oral Surgery   (United States)

^m HAUKELAND UNIVERSITY HOSPITAL   (Norway)

ⁿ MCMASTER UNIVERSITY   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALLOANTIBODY; FIBRINOGEN; HEMOGLOBIN; HLA ANTIBODY; HLA ANTIGEN CLASS 1; RIBOFLAVIN; THROMBOCYTE CONCENTRATE;

ADULT; ADVERSE EVENT; ALLOIMMUNIZATION; ARTICLE; BLEEDING DISORDER; BLOOD STORAGE; BLOOD TRANSFUSION REACTION; CLINICAL ASSESSMENT; COMPARATIVE STUDY; CONTROLLED STUDY; FEMALE; HEMATOLOGIC MALIGNANCY; HEMOSTASIS; HUMAN; ILLUMINATION; INFECTIOUS AGENT; INTENTION TO TREAT ANALYSIS; LUNG INJURY; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; PLASMA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THERAPY EFFECT; THROMBOCYTE; THROMBOCYTE FUNCTION; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; ULTRAVIOLET B RADIATION; WORLD HEALTH ORGANIZATION; BLOOD CLOTTING; BLOOD CLOTTING PARAMETERS; KAPLAN MEIER METHOD; META ANALYSIS; METABOLISM; MULTICENTER STUDY (TOPIC); PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC);

BLOOD COAGULATION; BLOOD PLATELETS; FEMALE; HEMOSTASIS; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MULTICENTER STUDIES AS TOPIC; PATIENT OUTCOME ASSESSMENT; PLATELET FUNCTION TESTS; PLATELET TRANSFUSION; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85048103316     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2018-02-831289     Document Type: Article

References (29)

1. 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(10): 1496-1504.
2. Lin L, Hanson CV, Alter HJ, et al. Inactivation of viruses in platelet concentrates by photochemical treatment with amotosalen and long-wavelength ultraviolet light. Transfusion. 2005;45(4):580-590.
3. Ruane PH, Edrich R, Gampp D, Keil SD, Leonard RL, Goodrich RP. Photochemical inactivation of selected viruses and bacteria in platelet concentrates using riboflavin and light. Transfusion. 2004;44(6): 877-885.
4. Goodrich RP, Edrich RA, Li J, Seghatchian J. The Mirasol PRT system for pathogen reduction of platelets and plasma: an overview of current status and future trends. Transfus Apheresis Sci. 2006;35(1):5-17.
5. Grass JA, Hei DJ, Metchette K, et al. Inactivation of leukocytes in platelet concentrates by photochemical treatment with psoralen plus UVA. Blood. 1998;91(6):2180-2188.
6. Marschner S, Fast LD, Baldwin WM III, Slichter SJ, Goodrich RP. White blood cell inactivation after treatment with riboflavin and ultraviolet light. Transfusion. 2010; 50(11):2489-2498.
7. Slichter SJ, Pellham E, Bailey SL, et al. Leukofiltration plus pathogen reduction prevents alloimmune platelet refractoriness in a dog transfusion model. Blood. 2017;130(8): 1052-1061.
8. Estcourt LJ, Malouf R, Hopewell S, et al. Pathogen-reduced platelets for the prevention of bleeding. Cochrane Database Syst Rev. 2017;7:CD009072.
9. Reddy HL, Dayan AD, Cavagnaro J, Gad S, Li J, Goodrich RP. Toxicity testing of a novel riboflavin-based technology for pathogen reduction and white blood cell inactivation. Transfus Med Rev. 2008;22(2): 133-153.
10. 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(11): 2362-2375.
11. 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(5):1171-1183.
12. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer. 1981;47(1):207-214.
13. Ypma PF, van der Meer PF, Heddle NM, et al; PREPAReS Study Group. A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial. BMJ Open. 2016; 6(1):e010156.
14. van der Meer PF, Couture C, Hervig T, et al. Experiences with semi-routine production of riboflavin and UV-B pathogen-inactivated platelet concentrates in three blood centres. Vox Sang. 2017;112(1):9-17.
15. Middelburg RA, Ypma PF, van der Meer PF, van Wordragen-Vlaswinkel RJ, Eissen O, Kerkhoffs JL. Measuring clinical bleeding using a standardized daily report form and a computer algorithm for adjudication of WHO bleeding grades. Vox Sang. 2013;105(2): 144-149.
16. Kopko PM, Warner P, Kresie L, Pancoska C. Methods for the selection of platelet products for alloimmune-refractory patients. Transfusion. 2015;55(2):235-244.
17. Slichter SJ, Kaufman RM, Assmann SF, et al. Dose of prophylactic platelet transfusions and prevention of hemorrhage. N Engl J Med. 2010;362(7):600-613.
18. Heddle NM, Cook RJ, Tinmouth A, et al; SToP Study Investigators of the BEST Collaborative. A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia. Blood. 2009;113(7):1564-1573.
19. Ypma PF, Kerkhoffs JL, van Hilten JA, et al. The observation of bleeding complications in haemato-oncological patients: stringent watching, relevant reporting. Transfus Med. 2012;22(6):426-431.
20. DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet. 1999;354(9194): 1983-1988.
21. Mauri L, D’Agostino RB Sr. Challenges in the design and interpretation of noninferiority trials. N Engl J Med. 2017; 377(14):1357-1367.
22. Garban F, Guyard A, Labussière H, et al; Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process (EFFIPAP) Study Group. Comparison of the hemostatic efficacy of pathogen-reduced platelets vs untreated platelets in patients with thrombocytopenia and malignant hematologic diseases. A randomized clinical trial. JAMA Oncol. 2018;4(4):468-475.
23. Stivala S, Gobbato S, Infanti L, et al. Amotosalen/ultraviolet A pathogen inactivation technology reduces platelet acti-vatability, induces apoptosis and accelerates clearance. Haematologica. 2017;102(10): 1650-1660.
24. Zeddies S, De Cuyper IM, van der Meer PF, et al. Pathogen reduction treatment using riboflavin and ultraviolet light impairs platelet reactivity toward specific agonists in vitro. Transfusion. 2014;54(9): 2292-2300.
25. Snyder E, McCullough J, Slichter SJ, et al; SPRINT Study Group. Clinical safety of platelets photochemically treated with amotosalen HCl and ultraviolet A light for pathogen inactivation: the SPRINT trial. Transfusion. 2005;45(12):1864-1875.
26. Kerkhoffs JL, van Putten WL, Novotny VM, et al; Dutch - Belgian HOVON cooperative group. Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction. Br J Haematol. 2010; 150(2):209-217.
27. Jackman RP, Muench MO, Inglis H, et al. Reduced MHC alloimmunization and partial tolerance protection with pathogen reduction of whole blood. Transfusion. 2017;57(2): 337-348.
28. Norris PJ, Kaidarova Z, Maiorana E, et al. Ultraviolet light-based pathogen inactivation and alloimmunization after platelet transfusion: results from a randomized trial. Transfusion. 2018;58(5):1210-1217.
29. van der Meer PF, Bontekoe IJ, Daal BB, de Korte D. Riboflavin and UV light treatment of platelets: a protective effect of platelet additive solution? Transfusion. 2015;55(8): 1900-1908.