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Quality assessment of red blood cell suspensions derived from pathogen-reduced whole blood

Vox Sang. 2021 May;116(5):547-556 doi: 10.1111/vox.13039.
PICO Summary
POPULATION:

Whole blood units from healthy donors (n= 50).

INTERVENTION:

Pathogen-reduction with riboflavin and ultraviolet light (n= 25).

COMPARISON:

Gamma‐irradiation (n= 25).

OUTCOME:

The quality of RBCS from both groups was largely the same, except for haemolysis and red blood cell fragility, which were more pronounced in the pathogen-reduced group. This finding limited the shelf life of pathogen-reduced RBCS to 14 days.

Abstract
BACKGROUND:

We used laboratory indicators to evaluate the quality of pathogen-reduced red blood cell suspension (RBCS) compared with gamma-irradiated RBCS.

MATERIALS AND METHODS:

To determine biochemical and metabolic parameters of RBCS, we obtained 50 whole blood units from healthy volunteers and randomized them into 2 groups: 25 were pathogen-reduced, and then, RBCS prepared from them. RBCS from the other 25 was gamma-irradiated. Sampling was carried out on day zero before and after treatment and at 7, 14, 21 and 28 days. To determine lymphocyte inactivation, we collected another 35 whole blood units. Each was sampled to form 3 study groups: untreated, gamma-irradiated and pathogen-reduced. Daily sampling was carried out during 3 days of storage.

RESULTS:

The quality of RBCS from both groups was largely the same, except for haemolysis and red blood cell fragility, which were more pronounced in the pathogen-reduced group. This finding limited the shelf life of pathogen-reduced RBCS to 14 days. Lymphocyte viability was significantly reduced after both treatments. Proliferation of lymphocytes after pathogen reduction was reduced to the detection limit, while low-level proliferation was observed in gamma-irradiated samples.

CONCLUSION:

Pathogen-reduced red blood cells have acceptable quality and can be used for transfusion within 14 days. Results of inactivation of lymphocytes demonstrate that pathogen reduction technology, applied on WB, can serve as an alternative to irradiation.

Metadata
KEYWORDS: blood component production; blood processing; blood safety; haemovigilance
MESH HEADINGS: Blood Preservation; Erythrocyte Count; Erythrocytes; Gamma Rays; Hemolysis; Humans; Random Allocation
Study Details
Study Design: Randomised Controlled Trial
Language: eng
Credits: Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine