NCT02485366

Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Defects, Congenital

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2015-06-30
• Last updated: 2020-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study