Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
jill cholette, University of Rochester
ClinicalTrials.gov Identifier:
NCT00693498
First received: June 5, 2008
Last updated: November 28, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Rochester:

Primary Outcome Measures:
  • 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio [ Time Frame: 12 hours post-cardiopulmonary bypass ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00693498

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

No publications provided by University of Rochester

Additional 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
Study First Received: June 5, 2008
Results First Received: November 30, 2011
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
pediatrics
congenital heart disease

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

ClinicalTrials.gov processed this record on September 14, 2014