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The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population (ABC-TOP)

Primary Purpose

Bone Marrow Failure Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fresh Human Red Blood Cells
Aged Human Red Blood Cells
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Marrow Failure Syndrome focused on measuring transfusion, red blood cell, transfusion reaction, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients requiring outpatient chronic red cell transfusions (2 or more red blood cell units per month for at least 3 consecutive months) in an ambulatory clinic within the Calgary Zone

Exclusion Criteria:

  • prerequisite for fresh or irradiated blood due to a pre-existing medical reason
  • hemodialysis dependence
  • chronic disease that has acutely decompensated, with a life expectancy of less than 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Fresh Human Red Blood Cells

    Aged Human Red Blood Cells

    Arm Description

    Participants will receive transfusion of human donor red blood cells that are less than or equal to 7 days of age from the time of donation.

    Participants will receive transfusion of human donor red blood cells that are greater than 21 days and up to a maximum of 42 days of age from the time of donation.

    Outcomes

    Primary Outcome Measures

    Red blood cell transfusion rate
    Product utilization, comparing the number and frequency of red blood cell units transfused to the chronically transfused outpatient population eligible for trial participation

    Secondary Outcome Measures

    Ferritin burden
    Based on results of laboratory test results available in the participant's electronic medical record, as ordered as a part of standard care by the primary hematologist
    Total cost of blood product transfusion
    Approximate sum of the cost of blood products transfused and nursing services required in the outpatient hospital treatment rooms when transfusions are administered throughout the study period
    Number of hours spent receiving blood products
    Sum of the number of patient hours spent receiving transfusions in the hospital treatment room setting
    Transfusion reaction frequency
    Number and type of transfusion reactions experienced by patients receiving transfusions throughout the study period, as reported to transfusion medicine by nursing, according to standard practice protocols

    Full Information

    First Posted
    March 5, 2015
    Last Updated
    December 19, 2015
    Sponsor
    University of Calgary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02393508
    Brief Title
    The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population
    Acronym
    ABC-TOP
    Official Title
    The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Calgary

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study, the investigators will be evaluating the impact of red blood cell age in patients receiving chronic blood transfusions in the outpatient setting. This study will have a double-bind, randomized trial design, meaning that the investigators and participants will not be told the group assignment at study enrollment. Study participants will be randomly divided into two groups (50% of participants in each group) by a computer generated block randomization schema. The 'fresh blood' group will receive blood units that are 7 or less from the time of donor collection, and the 'aged blood' group will receive blood units that are greater than 21 to 42 days from the time of donor collection. The number of units of blood transfused will be decided based on the participant's hemoglobin level before blood transfusion. The primary goal of our study is to compare annual red blood cell product use (the number of units given per patient in a year). The investigators will also be comparing groups to evaluate the transfusion reaction frequency, iron burden (based on the level of ferritin in the blood), overall transfusion and care cost difference, and participant time spent in outpatient departments. Our hypothesis is that use of fresh blood in chronically transfused patients will lead to a decrease the in red cell transfusion rate, with subsequent clinical benefits including reduction of transfusion reaction frequency and systemic iron burden. This study will be taking place within the Calgary Zone of Alberta Health Services only.
    Detailed Description
    Background: Chronically transfused medical outpatients comprise a significant proportion of transfusion recipients annually. At this time, the impact of red cell transfusion on patient outcomes in this patient population is unknown. Objective: Our goal is to prospectively evaluate impact of red cell age on product utilization in a cohort of chronically transfused medical outpatients randomized to receive red blood cells that are fresh (≤ 7 days from collection) or aged (>21-42 days from collection). To our knowledge, no other studies with a similar design or objective have been published. Patient population and study design: Patients meeting eligibility criteria will be invited to participate in our study. Our chronically transfused outpatient population is defined as adults who are receiving 2 or more red cell units per month for at least 3 consecutive months in an ambulatory clinic setting within the Calgary Zone. We plan to incorporate both prospective and retrospective data collection and analysis in our study design. All eligible, consenting participants will be randomized into one of the two study arms. Investigators and participants will be blinded to participant group assignment. Laboratory parameters and red cell transfusion: Parameters of usual pre-transfusion bloodwork will be followed, including complete blood count (CBC) and ferritin levels. Red cell transfusion volumes for chronic transfusion throughout the study will be determined according to a locally established protocol to achieve a post-transfusion hemoglobin (Hb) of 95-105 g/dL. Given that 1 adult unit of red cells raises the baseline Hb by approximately 10 g/L, the following volumes will be given to patients during a single visit based on their pre-transfusion CBC: Hb <75 = 3 units, Hb 75-84 = 2 units, Hb 85-94 = 1 unit, Hb ≥95 = no transfusion. A routine post-transfusion CBC will not be performed. According to usual care, participants will have a standing order to perform a CBC at least weekly, or if they have subjective symptoms of anemia to help guide subsequent transfusions. Study participants will receive blood transfusion in usual locations designated within the Calgary Zone for administration of chronic blood transfusions. These include medical daycare units at the Foothills Medical Center, Tom Baker Cancer Center, Peter Lougheed Center, and South Health Campus. Nurses will administer blood transfusions according to standard practice, without change in transfusion protocol despite patient study participation. Duration of participation will be 1 year from the time of enrollment. Participant health record access will be required for collection of demographic information and retrospective data involving any transfusions received within 1 year prior to enrollment to establish transfusion chronicity and health patterns. Outcomes will be based on a comparison of results between the study groups. Prospectively collected data based on red cell age will additionally be compared to retrospective transfusion related information (including red cell transfusion frequency and blood age) from within 1 year from the time of enrollment, if available. We plan to enroll a maximum total of 60 participants, with assignment of 30 patients into each group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Marrow Failure Syndrome
    Keywords
    transfusion, red blood cell, transfusion reaction, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fresh Human Red Blood Cells
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive transfusion of human donor red blood cells that are less than or equal to 7 days of age from the time of donation.
    Arm Title
    Aged Human Red Blood Cells
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive transfusion of human donor red blood cells that are greater than 21 days and up to a maximum of 42 days of age from the time of donation.
    Intervention Type
    Other
    Intervention Name(s)
    Fresh Human Red Blood Cells
    Intervention Description
    Red cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion.
    Intervention Type
    Other
    Intervention Name(s)
    Aged Human Red Blood Cells
    Intervention Description
    Red cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion.
    Primary Outcome Measure Information:
    Title
    Red blood cell transfusion rate
    Description
    Product utilization, comparing the number and frequency of red blood cell units transfused to the chronically transfused outpatient population eligible for trial participation
    Time Frame
    1 year from the time of enrollment
    Secondary Outcome Measure Information:
    Title
    Ferritin burden
    Description
    Based on results of laboratory test results available in the participant's electronic medical record, as ordered as a part of standard care by the primary hematologist
    Time Frame
    At enrollment, 3 months, 6 months, 9 months and 12 months
    Title
    Total cost of blood product transfusion
    Description
    Approximate sum of the cost of blood products transfused and nursing services required in the outpatient hospital treatment rooms when transfusions are administered throughout the study period
    Time Frame
    1 year from the time of enrollment
    Title
    Number of hours spent receiving blood products
    Description
    Sum of the number of patient hours spent receiving transfusions in the hospital treatment room setting
    Time Frame
    1 year from the time of enrollment
    Title
    Transfusion reaction frequency
    Description
    Number and type of transfusion reactions experienced by patients receiving transfusions throughout the study period, as reported to transfusion medicine by nursing, according to standard practice protocols
    Time Frame
    1 year from the time of enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients requiring outpatient chronic red cell transfusions (2 or more red blood cell units per month for at least 3 consecutive months) in an ambulatory clinic within the Calgary Zone Exclusion Criteria: prerequisite for fresh or irradiated blood due to a pre-existing medical reason hemodialysis dependence chronic disease that has acutely decompensated, with a life expectancy of less than 3 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meer-Taher Shabani-Rad, MD, FRCPC
    Organizational Affiliation
    University of Calgary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15845701
    Citation
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    Results Reference
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    16849995
    Citation
    Taylor RW, O'Brien J, Trottier SJ, Manganaro L, Cytron M, Lesko MF, Arnzen K, Cappadoro C, Fu M, Plisco MS, Sadaka FG, Veremakis C. Red blood cell transfusions and nosocomial infections in critically ill patients. Crit Care Med. 2006 Sep;34(9):2302-8; quiz 2309. doi: 10.1097/01.CCM.0000234034.51040.7F.
    Results Reference
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    PubMed Identifier
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    Citation
    Weinberg JA, McGwin G Jr, Griffin RL, Huynh VQ, Cherry SA 3rd, Marques MB, Reiff DA, Kerby JD, Rue LW 3rd. Age of transfused blood: an independent predictor of mortality despite universal leukoreduction. J Trauma. 2008 Aug;65(2):279-82; discussion 282-4. doi: 10.1097/TA.0b013e31817c9687.
    Results Reference
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    PubMed Identifier
    19772604
    Citation
    Spinella PC, Carroll CL, Staff I, Gross R, Mc Quay J, Keibel L, Wade CE, Holcomb JB. Duration of red blood cell storage is associated with increased incidence of deep vein thrombosis and in hospital mortality in patients with traumatic injuries. Crit Care. 2009;13(5):R151. doi: 10.1186/cc8050. Epub 2009 Sep 22.
    Results Reference
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    PubMed Identifier
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    Citation
    Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008 Mar 20;358(12):1229-39. doi: 10.1056/NEJMoa070403.
    Results Reference
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    PubMed Identifier
    10720122
    Citation
    Mynster T, Nielsen HJ. The impact of storage time of transfused blood on postoperative infectious complications in rectal cancer surgery. Danish RANX05 Colorectal Cancer Study Group. Scand J Gastroenterol. 2000 Feb;35(2):212-7. doi: 10.1080/003655200750024416.
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    Citation
    Yuruk K, Milstein DM, Bezemer R, Bartels SA, Biemond BJ, Ince C. Transfusion of banked red blood cells and the effects on hemorrheology and microvascular hemodynamics in anemic hematology outpatients. Transfusion. 2013 Jun;53(6):1346-52. doi: 10.1111/j.1537-2995.2012.03905.x. Epub 2012 Sep 24.
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