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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Blood transfused during surgery will be treated with Rejuvesol.
The study interventions will take place during a routine admission for pediatric open heart surgery. The anesthetic technique for subjects undergoing cardiac surgery is standard care and the research study interventions will not change these practices in any way.
Duke Univerisity Medical Center
Durham, North Carolina, United States
Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration
Time frame: End of Surgery
Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)
Time frame: 2 hours
Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels
Time frame: end of bypass
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