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

NCT03056378 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: NYBC-0088
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transfusion Reaction; Anemia

Outcome Measures

Primary Outcomes (1)

• Quantitation of adverse events

  60 day endpoint

Secondary Outcomes (1)

• Quantitation of RBC alloantibody formation

  15 and 30 minutes post-transfusion

Study Arms (2)

Pooled RBCs

EXPERIMENTAL

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

Biological: Standard RBCs

Standard RBCs

ACTIVE COMPARATOR

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)

Biological: Standard RBCs

Interventions

Standard RBCs BIOLOGICAL

Transfusion of standard pRBCs that are matched for C, E and K

Pooled RBCs; Standard RBCs

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>= 18 years
• 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

You may not qualify if:

• Previously identified alloantibodies (other than to D, C, E and K)
• 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

Sponsors & Collaborators

• New York Blood Center: lead
• Westchester Medical Center: collaborator

Study Sites (1)

Westchester Medical Center/New York Medical College

Valhalla, New York, 10595, United States

Location

Related Publications (16)

• Hendrickson JE, Hillyer CD. Noninfectious serious hazards of transfusion. Anesth Analg. 2009 Mar;108(3):759-69. doi: 10.1213/ane.0b013e3181930a6e.

  PMID: 19224780 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.

  PMID: 24251374 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.

  PMID: 22229278 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.

  PMID: 27704557 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.

  PMID: 21332724 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.

  PMID: 22244869 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.

  PMID: 20497512 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.

  PMID: 15265126 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.

  PMID: 23363522 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.

  PMID: 21871776 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.

  PMID: 23607261 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.

  PMID: 27224258 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.

  PMID: 24995863 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.

  PMID: 19389029 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.

  PMID: 26814984 BACKGROUND

Related Links

• National Healthcare Safety Network Biovigilance component Hemovigilance module Surveillance Protocol: Center for Disease Control Prevention, ed.2017

MeSH Terms

Conditions

Transfusion Reaction; Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Beth Shaz, M.D.

  New York Blood Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: February 17, 2017
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

US (1)