The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population

Brief Title

The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population

Official Title

The Impact of Red Cell Age on Product Utilization in the Chronically Transfused Outpatient Population

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Red blood cell transfusion rate

Secondary Outcome

 Ferritin burden

Condition

Bone Marrow Failure Syndrome

Intervention

Fresh Human Red Blood Cells

Study Arms / Comparison Groups

 Fresh Human Red Blood Cells
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

60

Start Date

September 2015

Completion Date

December 2017

Primary Completion Date

March 2017

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Meer-Taher Shabani-Rad, MD, FRCPC, , 



Administrative Informations


NCT ID

NCT02393508

Organization ID

18-16748


Responsible Party

Principal Investigator

Study Sponsor

University of Calgary


Study Sponsor

Meer-Taher Shabani-Rad, MD, FRCPC, Principal Investigator, University of Calgary


Verification Date

December 2015