Sickle Cell Disease Clinical Trial
Official title:
Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
The objective of this proposal is to test the feasibility of red blood cell (RBC)
rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of
RBC rejuvenation in this population to determine if a larger clinical trial powered to
definitively characterize the benefits of rejuvenation is warranted.
This is a small pilot study is to see if restoring important energy molecules (ATP and
2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution
(Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects
will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6
transfusions (over approximately a 6-month period) in a pre-defined order to maximize
detection of any signal.
Blood transfusion is part of the standard care for individuals that have sickle cell disease.
Often these transfusions become needed quite frequently. The purpose of the red blood cells
in the blood is to deliver oxygen to the organs and tissues of the body. People with sickle
cell disease have abnormal red blood cells. Stored blood undergoes some changes that may make
it less effective in achieving this goal.
The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG)
in stored red blood cells before they are transfused, with a rejuvenating solution
(Rejuvesol), offers any advantages to individuals over standard blood transfusion. This is a
Food and Drug Administration (FDA) approved process that is described by the American
Association of Blood Banks for prolonging blood storage but not used for everyday
transfusions. The investigators want to use this process to improve blood transfused to
individuals who need frequent transfusions. Potential advantages include better delivery of
oxygen by the transfused red blood cells and easier release of oxygen to the tissues. In
addition the study will assess how using the rejuvenated blood affects the interval between
transfusions. This means possibly that transfusions may not be needed as often.
Although Rejuvesol has been previously approved by the FDA, it is not routinely used to
prepare standard blood transfusions to individuals who have sickle cell disease. Use of
Rejuvesol in this study is considered investigational.
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