Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

• Status: Withdrawn
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University

Criteria

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.