Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

University of Rochester

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Biological: Standard leukoreduced irradiated blood cell transfusion; Biological: Washed leukoreduced irradiated blood cell transfusions

Study type: Interventional

Funder types: Other

Identifiers

NCT00693498

24518

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: Under 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

1

Active Comparator group

Description:

Standard leukoreduced irradiated blood cell transfusion group

Treatment:

Biological: Standard leukoreduced irradiated blood cell transfusion

2

Experimental group

Description:

Washed leukoreduced irradiated blood cell transfusion group

Treatment:

Biological: Washed leukoreduced irradiated blood cell transfusions