POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units

Summary

The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared to standard leukoreduced RBC products stored in additive solution. The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.

Timeline

Start

2019-10

Primary completion

2020-12

Completion

2021-06

Outcome

Outcome not reported

Stopped (Enrollment): “No patients enrolled. Study withdrawn.”

Publications

• Background Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.
• Background Tobian AA, Fuller AK, Uglik K, Tisch DJ, Borge PD, Benjamin RJ, Ness PM, King KE. The impact of platelet additive solution apheresis platelets on allergic transfusion reactions and corrected count increment (CME). Transfusion. 2014 Jun;54(6):1523-9; quiz 1522. doi: 10.1111/trf.12498. Epub 2013 Nov 19.
• Background Hess JR; Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Scientific problems in the regulation of red blood cell products. Transfusion. 2012 Aug;52(8):1827-35. doi: 10.1111/j.1537-2995.2011.03511.x. Epub 2012 Jan 9.
• Background Marthur A, Stassinopoulos A, Hess JR, Narla M, Shaz BH. Effects of pooling multiple red blood cell units to improve storage. Blood 2012;120:3437
• Background Mathur A, Chowdhury R, Hillyer CD, Mitchell WB, Shaz BH. Storage characteristics of multiple-donor pooled red blood cells compared to single-donor red blood cell units. Transfusion. 2016 Dec;56(12):2941-2947. doi: 10.1111/trf.13866. Epub 2016 Oct 5.
• Background Lasalle-Williams M, Nuss R, Le T, Cole L, Hassell K, Murphy JR, Ambruso DR. Extended red blood cell antigen matching for transfusions in sickle cell disease: a review of a 14-year experience from a single center (CME). Transfusion. 2011 Aug;51(8):1732-9. doi: 10.1111/j.1537-2995.2010.03045.x. Epub 2011 Feb 18.
• Background Verduin EP, Brand A, Schonewille H. Is female sex a risk factor for red blood cell alloimmunization after transfusion? A systematic review. Transfus Med Rev. 2012 Oct;26(4):342-53, 353.e1-5. doi: 10.1016/j.tmrv.2011.12.001. Epub 2012 Jan 13.
• Background Custer B, Agapova M, Martinez RH. The cost-effectiveness of pathogen reduction technology as assessed using a multiple risk reduction model. Transfusion. 2010 Nov;50(11):2461-73. doi: 10.1111/j.1537-2995.2010.02704.x.
• Background Sweeney JD, Kouttab NM, Holme S, Kurtis JD, Cheves TA, Nelson EJ. Prestorage pooled whole-blood-derived leukoreduced platelets stored for seven days, preserve acceptable quality and do not show evidence of a mixed lymphocyte reaction. Transfusion. 2004 Aug;44(8):1212-9. doi: 10.1111/j.1537-2995.2004.03438.x.
• Background Thiele T, Heddle N, Greinacher A. Donor exposures in recipients of pooled platelet concentrates. N Engl J Med. 2013 Jan 31;368(5):487-9. doi: 10.1056/NEJMc1213383. No abstract available.
• Background Zou S, Stramer SL, Dodd RY. Donor testing and risk: current prevalence, incidence, and residual risk of transfusion-transmissible agents in US allogeneic donations. Transfus Med Rev. 2012 Apr;26(2):119-28. doi: 10.1016/j.tmrv.2011.07.007. Epub 2011 Aug 25.
• Background Stramer SL, Notari EP, Krysztof DE, Dodd RY. Hepatitis B virus testing by minipool nucleic acid testing: does it improve blood safety? Transfusion. 2013 Oct;53(10 Pt 2):2449-58. doi: 10.1111/trf.12213. Epub 2013 Apr 23.
• Background Levin AE, Williamson PC, Bloch EM, Clifford J, Cyrus S, Shaz BH, Kessler D, Gorlin J, Erwin JL, Krueger NX, Williams GV, Penezina O, Telford SR 4th, Branda JA, Krause PJ, Wormser GP, Schotthoefer AM, Fritsche TR, Busch MP. Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay. Transfusion. 2016 Jul;56(7):1866-74. doi: 10.1111/trf.13618. Epub 2016 May 25.
• Background Levin AE, Williamson PC, Erwin JL, Cyrus S, Bloch EM, Shaz BH, Kessler D, Telford SR 3rd, Krause PJ, Wormser GP, Ni X, Wang H, Krueger NX, Caglioti S, Busch MP. Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay. Transfusion. 2014 Sep;54(9):2237-44. doi: 10.1111/trf.12763. Epub 2014 Jul 4.
• Background Tormey CA, Sweeney JD, Champion MH, Pisciotto PT, Snyder EL, Wu Y. Analysis of transfusion reactions associated with prestorage-pooled platelet components. Transfusion. 2009 Jun;49(6):1242-7. doi: 10.1111/j.1537-2995.2009.02128.x. Epub 2009 Mar 23.
• Background Daurat A, Roger C, Gris J, Daurat G, Feissel M, Le Manach Y, Lefrant J, Muller L. Apheresis platelets are more frequently associated with adverse reactions than pooled platelets both in recipients and in donors: a study from French hemovigilance data. Transfusion. 2016 Jun;56(6):1295-303. doi: 10.1111/trf.13475. Epub 2016 Jan 26.

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