Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard leukoreduced irradiated blood cell transfusion
Washed leukoreduced irradiated blood cell transfusions
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring pediatrics, congenital heart disease
Eligibility Criteria
Inclusion Criteria:
- age < 18 years
- surgical repair at URMC by the pediatric cardiac surgical team
- informed consent signed by the parent or legal guardian, and if applicable, assent obtained from the subject.
Exclusion Criteria:
- Age ≥18 years
- inability to provide consent/assent; 3) subjects having "emergent" surgical procedures. Subjects with chronic inflammatory or autoimmune disorders will not be excluded
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Standard leukoreduced irradiated blood cell transfusion group
Washed leukoreduced irradiated blood cell transfusion group
Outcomes
Primary Outcome Measures
12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio
plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.
Secondary Outcome Measures
Median wrCRP Level
wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00693498
Brief Title
Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery
Official Title
Standard vs. Washed Blood Cell Transfusions in Pediatric Cardiac Surgery: Impact on Post-operative Inflammation as Evidenced by the IL-6 to IL-10 Ratio.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Children having open heart surgery to repair congenital heart defects demonstrate a large inflammatory response to the heart-lung machine and to surgery itself. In general, the more intense their inflammatory response, the more critically ill they are following surgery. These children routinely require large numbers of blood transfusions during and following surgery as part of their medical management that adds to their heightened inflammatory state. Whether additional steps to "wash" blood products and remove the substances contributing to post-transfusion inflammation will limit this response, and improve the health of children following open heart surgery, remains to be studied.
Aims: To compare the inflammatory response in children having open heart surgery who receive washed versus unwashed blood transfusions.
Methods: We will randomly assign children having open heart surgery to one of two groups: group 1 will receive blood transfusions per the current standard of care, group 2 will receive blood transfusions that have been washed in addition to the current standard of care. We will then use blood tests to measure the inflammatory response in children of each group. We will compare the results to determine whether washing blood transfusions decreases inflammation and post-operative complications following open heart surgery.
Conclusion: We believe that washing blood transfusions given to children following open heart surgery will decrease their inflammatory response and improve their overall health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
pediatrics, congenital heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard leukoreduced irradiated blood cell transfusion group
Arm Title
2
Arm Type
Experimental
Arm Description
Washed leukoreduced irradiated blood cell transfusion group
Intervention Type
Biological
Intervention Name(s)
Standard leukoreduced irradiated blood cell transfusion
Intervention Description
standard vs washed blood cell transfusions
Intervention Type
Biological
Intervention Name(s)
Washed leukoreduced irradiated blood cell transfusions
Intervention Description
washed leukoreduced irradiated blood cell transfusions
Primary Outcome Measure Information:
Title
12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio
Description
plasma was obtained pre-op, immediately once off cardiopulmonary bypass (CPB), six hours following CPB and 12 hours following CPB. The plasma was centrifuged and the supernatant collected and stored at -70 degrees. The samples then underwent Luminex testing for IL-6 and IL-10 levels, and the IL-6:IL-10 ratio was calculated (IL-6 being the numerator and IL-12 being the denominator). The 12 hour ratio was the primary outcome measure.
Time Frame
12 hours post-cardiopulmonary bypass
Secondary Outcome Measure Information:
Title
Median wrCRP Level
Description
wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects
Time Frame
post op day 1 and 2
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age < 18 years
surgical repair at URMC by the pediatric cardiac surgical team
informed consent signed by the parent or legal guardian, and if applicable, assent obtained from the subject.
Exclusion Criteria:
Age ≥18 years
inability to provide consent/assent; 3) subjects having "emergent" surgical procedures. Subjects with chronic inflammatory or autoimmune disorders will not be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Cholette, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
21926663
Citation
Cholette JM, Henrichs KF, Alfieris GM, Powers KS, Phipps R, Spinelli SL, Swartz M, Gensini F, Daugherty LE, Nazarian E, Rubenstein JS, Sweeney D, Eaton M, Lerner NB, Blumberg N. Washing red blood cells and platelets transfused in cardiac surgery reduces postoperative inflammation and number of transfusions: results of a prospective, randomized, controlled clinical trial. Pediatr Crit Care Med. 2012 May;13(3):290-9. doi: 10.1097/PCC.0b013e31822f173c.
Results Reference
derived
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Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery
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