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Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Primary Purpose

Heart Defects, Congenital

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rejuvesol
Cardiac surgery
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Heart Defects, Congenital focused on measuring Rejuvenated packed red blood cells

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Duke Univerisity Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rejuvenated PRBCs

Arm Description

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

Outcomes

Primary Outcome Measures

Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration
Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)
Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels

Secondary Outcome Measures

Full Information

First Posted
June 26, 2015
Last Updated
April 23, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02485366
Brief Title
Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Official Title
Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Product unavailability
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital
Keywords
Rejuvenated packed red blood cells

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rejuvenated PRBCs
Arm Type
Experimental
Arm Description
The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).
Intervention Type
Drug
Intervention Name(s)
Rejuvesol
Intervention Description
Blood transfused during surgery will be treated with Rejuvesol.
Intervention Type
Procedure
Intervention Name(s)
Cardiac surgery
Intervention Description
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 Measure Information:
Title
Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration
Time Frame
End of Surgery
Title
Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)
Time Frame
2 hours
Title
Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels
Time Frame
end of bypass

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Lodge, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Univerisity Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

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