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Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485366
Recruitment Status : Withdrawn (Product unavailability)
First Posted : June 30, 2015
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Drug: Rejuvesol Procedure: Cardiac surgery Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rejuvenated PRBCs
The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).
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.




Primary Outcome Measures :
  1. Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration [ Time Frame: End of Surgery ]
  2. Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL) [ Time Frame: 2 hours ]
  3. Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels [ Time Frame: end of bypass ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485366


Locations
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United States, North Carolina
Duke Univerisity Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Andrew Lodge, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02485366    
Other Study ID Numbers: Pro00021487
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Rejuvenated packed red blood cells
Additional relevant MeSH terms:
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Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases