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Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693498
First Posted: June 9, 2008
Last Update Posted: November 29, 2012
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.
Information provided by (Responsible Party):
jill cholette, University of Rochester
  Purpose

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.


Condition Intervention
Congenital Heart Disease Biological: Standard leukoreduced irradiated blood cell transfusion Biological: Washed leukoreduced irradiated blood cell transfusions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by jill cholette, University of Rochester:

Primary Outcome Measures:
  • 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio [ Time Frame: 12 hours post-cardiopulmonary bypass ]
    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:
  • wrCRP Levels [ Time Frame: days ]

Enrollment: 162
Study Start Date: July 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard leukoreduced irradiated blood cell transfusion group
Biological: Standard leukoreduced irradiated blood cell transfusion
standard vs washed blood cell transfusions
Experimental: 2
Washed leukoreduced irradiated blood cell transfusion group
Biological: Washed leukoreduced irradiated blood cell transfusions
washed leukoreduced irradiated blood cell transfusions

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00693498


Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jill Cholette, MD University of Rochester
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: jill cholette, Assistant Professior, University of Rochester
ClinicalTrials.gov Identifier: NCT00693498     History of Changes
Other Study ID Numbers: 24518
First Submitted: June 5, 2008
First Posted: June 9, 2008
Results First Submitted: November 30, 2011
Results First Posted: November 29, 2012
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by jill cholette, University of Rochester:
pediatrics
congenital heart disease

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities