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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
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring pediatrics, congenital heart disease

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age < 18 years
  2. surgical repair at URMC by the pediatric cardiac surgical team
  3. informed consent signed by the parent or legal guardian, and if applicable, assent obtained from the subject.

Exclusion Criteria:

  1. Age ≥18 years
  2. 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

    First Posted
    June 5, 2008
    Last Updated
    January 4, 2018
    Sponsor
    University of Rochester
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    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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