Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02485366|
Recruitment Status : Withdrawn (Product unavailability)
First Posted : June 30, 2015
Last Update Posted : April 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Defects, Congenital||Drug: Rejuvesol Procedure: Cardiac surgery||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Rejuvenated PRBCs
The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).
Blood transfused during surgery will be treated with Rejuvesol.
Procedure: Cardiac surgery
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485366
|United States, North Carolina|
|Duke Univerisity Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Andrew Lodge, MD||Duke University|