Age of Blood in Sickle Cell Transfusion -The Effects of Phosphotidylserine Expression on Older Red Cell Units in Adults With Sickle Cell Disease

About the study

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.

Study point of contact

Matthew Karafin, MD
414-937-6809
[email protected]
David Wichlan
919-966-6876
[email protected]

Locations

84 United States sites

Age

16 Years - 60 Years

Phase

Phase 2/Phase 3

Study type

Interventional

Gender

All

Interventions

Biological

participation requirements

age 16 to 60 years
have diagnosis of sickle cell disease
receiving outpatient red cell transfusion therapy
outpatient at the time of transfusion

participation restrictions

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.

Locations

  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]
  • Atlanta, Georgia, United States, Emory University [Recruiting]
  • Chapel Hill, North Carolina, United States, University of North Carolina at Chapel Hill [Recruiting]
  • Milwaukee, Wisconsin, United States, Versiti Wisconsin [Completed]

MORE INFORMATION

View on ClinicalTrials.gov
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Last updated 2023-04-17