POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units
NCT ID: NCT03056378
Last Updated: 2019-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2019-10-31
2021-06-30
Brief Summary
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Detailed Description
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The pooled RBC units will be made by sterilely pooling five (5) single RBC units into one container where the blood will be mixed together, and then separated into five individual RBC units, ready to be used for transfusion. The purpose of the study is to determine the safety of the blood prepared in this new way compared to standard RBC products.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Pooled RBCs
Transfusion of an investigational transfusion blood component: POOLED-RBCs Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type), leukoreduced, and irradiated
Standard RBCs
Transfusion of standard pRBCs that are matched for C, E and K
Standard RBCs
Transfusion of standard transfusion blood component: additive solution leukoreduced, irradiated RBC product Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type)
Standard RBCs
Transfusion of standard pRBCs that are matched for C, E and K
Interventions
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Standard RBCs
Transfusion of standard pRBCs that are matched for C, E and K
Eligibility Criteria
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Inclusion Criteria
* Hematology/ oncology or other chronic transfusion dependent patients
* Patients who are in need of transfusion due to low hemoglobin level (\<8 gm/dl)
* Patients who only require one or two transfusion episode of 1-2 RBC units each during 60 day period
* Currently not planning to be pregnant during the study period
Exclusion Criteria
* Positive direct antiglobulin test, currently or within the last year
* Emergency transfusion
* Patients \< 18 years old
* Need for specialized products, such as washed
* Patients involved in other RBC transfusion clinical trial
* Currently or planning to be pregnant within the proposed study period
18 Years
99 Years
ALL
No
Sponsors
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Westchester Medical Center
OTHER
New York Blood Center
OTHER
Responsible Party
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Principal Investigators
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Beth Shaz, M.D.
Role: PRINCIPAL_INVESTIGATOR
New York Blood Center
Locations
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Westchester Medical Center/New York Medical College
Valhalla, New York, United States
Countries
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References
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Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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National Healthcare Safety Network Biovigilance component Hemovigilance module Surveillance Protocol: Center for Disease Control Prevention, ed.2017
Other Identifiers
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NYBC-0088
Identifier Type: -
Identifier Source: org_study_id