- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02485366
Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Univerisity Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
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Blood transfused during surgery will be treated with Rejuvesol.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration
Time Frame: End of Surgery
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End of Surgery
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Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)
Time Frame: 2 hours
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2 hours
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Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels
Time Frame: end of bypass
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end of bypass
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Lodge, MD, Duke University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00021487
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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