CompletedPhase 2/3

Age of Blood in Sickle Cell Transfusion

United States26 participantsStarted 2017-10-04

Plain-language summary

The Investigators hypothesize that older red cell units trigger phagocytosis and activation of circulating macrophages with a downstream immunomodulatory cascade and release of excess Non Transferrin Bound Iron(NTBI) that leads to increased rates of infection in adults with Sickle Cell Disease(SCD). To test this hypothesis, the study staff will perform a randomized prospective clinical trial. In aim 1, the study staff will determine the biochemical differences between ≥30 day-old versus ≤10 day-old units. In aim 2, the study staff will determine the physiologic effects of the transfused blood in a patient with SCD. Lastly, in aim 3, the study staff will explore the clinical implications of receiving older red cells over a 3 month period.

Who can participate

Age range16 Years – 60 Years

SexALL

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Inclusion Criteria: * age 16 to 60 years * have diagnosis of sickle cell disease * receiving outpatient red cell transfusion therapy * outpatient at the time of transfusion Exclusion criteria: * history of reactions to transfusion therapy that cannot be adequately managed by antihistamines * do not have crossmatch compatible red cells * participation in another therapeutic trial for SCD * pregnant * HIV positive * uncontrolled inter-current illness, or psychiatric illness/social situations that would limit compliance with study requirements.

What they're measuring

Proportion of Biochemically Old Red Cell Units

Timeframe: through third transfusion, an average of 18 weeks

Trial details

NCT IDNCT03704922

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-11

Results submitted2024-10-24

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