Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Heart Defects, Congenital Clinical Trial

Official title:

Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02485366
• Other study ID #: Pro00021487
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 2020
• Est. completion date: June 2021

Study information

• Verified date: April 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Univerisity Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration		End of Surgery
Primary	Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)		2 hours
Primary	Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels		end of bypass