The impact of red cell storage age on transfused patients with sickle cell disease: protocol of a pilot randomized clinical trial to evaluate changes in inflammation and clinical transfusion efficacy.

Abstract

Background: Despite fulfilling all requirements for donor blood units as defined by the FDA, a number of patients with sickle cell disease (SCD) are transfused with red blood cell (RBC) units that are near the end of their storage life, exposing them to the potentially adverse components of the red cell storage lesion. Due to their chronically inflamed state, patients with SCD may be particularly susceptible to these components. We present here a pilot study protocol for testing the impact of fresh vs older red cell units in chronically transfused adults with SCD.

Materials and methods: This is a randomized, prospective, clinical trial. We aimed to recruit forty chronically transfused adults or adolescents with SCD who receive regular RBC transfusions for their clinical care and randomize these patients to receive either units greater than or equal to 30 days, or units less than or equal to 10 days for 3 consecutive outpatient transfusion events.

Results: The primary endpoint is the metabolic differences identified between units transfused that are greater than or equal to 30 days, and those units less than or equal to 10 days. The secondary endpoint evaluates the change in blood monocyte activation at 2 hours after transfusion between the two groups. Lastly, we evaluate unit RBC efficacy via changes in hemoglobin/day, hemoglobin A%/day, hospitalization rate, pain scores, and infections as documented via blood and urine cultures.

Discussion: This study promises to provide evidence as to whether metabolically older red cell units affect the quality and efficacy of chronic transfusion therapy for adults with SCD and has the potential to guide the need for future study on this important clinical issue.