Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Status:
Withdrawn
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Blood transfusion is nearly always needed during open heart surgery in children less than 15
kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the
organs and tissues of the body. 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 children 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 children undergoing heart surgery.
Although Rejuvesol has been previously approved by the FDA, it is not routinely used to
prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this
study is considered investigational. This is a pilot study and data will be collected for
future protocol development.