Heart Defects, Congenital
Conditions
Keywords
Rejuvenated packed red blood cells
Brief 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.
Interventions
DRUGRejuvesol
Blood transfused during surgery will be treated with Rejuvesol.
PROCEDURECardiac 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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime) * children undergoing cardiac surgery with cardiopulmonary bypass
Exclusion criteria
* refusal of blood products * end-stage renal disease * planned avoidance of CPB * use of non- heparin anticoagulants * participation in an experimental drug or device protocol within 30 days * existing hemoglobinopathy * allergy requiring washed RBCs * immunocompromise requiring special blood product treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration | End of Surgery |
| Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL) | 2 hours |
| Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels | end of bypass |
Countries
United States
Outcome results
None listed