Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Duke University

Status and phase: Withdrawn; Phase 4

Conditions: Heart Defects, Congenital

Treatments: Procedure: Cardiac surgery; Drug: Rejuvesol

Study type: Interventional

Funder types: Other

Identifiers

NCT02485366

Pro00021487

Details and patient eligibility

About

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.

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Rejuvenated PRBCs

Experimental group

Description:

The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).

Treatment:

Procedure: Cardiac surgery

Drug: Rejuvesol