Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard leukoreduced irradiated blood cell transfusion group

Group Type ACTIVE_COMPARATOR

Standard leukoreduced irradiated blood cell transfusion

Intervention Type BIOLOGICAL

standard vs washed blood cell transfusions

2

Washed leukoreduced irradiated blood cell transfusion group

Group Type EXPERIMENTAL

Washed leukoreduced irradiated blood cell transfusions

Intervention Type BIOLOGICAL

washed leukoreduced irradiated blood cell transfusions

Interventions

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Standard leukoreduced irradiated blood cell transfusion

standard vs washed blood cell transfusions

Intervention Type BIOLOGICAL

Washed leukoreduced irradiated blood cell transfusions

washed leukoreduced irradiated blood cell transfusions

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No