Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

NCT02485366 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Pro00021487
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects, Congenital

Keywords

Rejuvenated packed red blood cells

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Rejuvenated PRBCs

EXPERIMENTAL

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

Drug: Rejuvesol; Procedure: Cardiac surgery

Interventions

Rejuvesol DRUG

Blood transfused during surgery will be treated with Rejuvesol.

Rejuvenated PRBCs

Cardiac surgery PROCEDURE

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.

Rejuvenated PRBCs

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime)
• children undergoing cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Univerisity Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Andrew Lodge, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: June 30, 2015
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 27, 2020

Record last verified: 2020-04

Locations

US (1)