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Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

NCT00693498 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2018-01-08

Study results available
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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.

Conditions

  • Congenital Heart Disease

Interventions

BIOLOGICAL

Standard leukoreduced irradiated blood cell transfusion

standard vs washed blood cell transfusions

BIOLOGICAL

Washed leukoreduced irradiated blood cell transfusions

washed leukoreduced irradiated blood cell transfusions

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Jill Cholette, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-11-30
Completion
2009-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00693498 on ClinicalTrials.gov