Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

Study Overview
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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.

Official Title
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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.

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Biological: Standard leukoreduced irradiated blood cell transfusion
* Biological: Washed leukoreduced irradiated blood cell transfusions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age < 18 years surgical repair at URMC by the pediatric cardiac surgical team informed consent signed by the parent or legal guardian, and if applicable, assent obtained from the subject. Exclusion Criteria: Age ≥18 years inability to provide consent/assent; 3) subjects having emergent surgical procedures. Subjects with chronic inflammatory or autoimmune disorders will not be excluded

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard leukoreduced irradiated blood cell transfusion group | Biological: Standard leukoreduced irradiated blood cell transfusion<br>* standard vs washed blood cell transfusions<br>|
| Experimental: 2<br>Washed leukoreduced irradiated blood cell transfusion group | Biological: Washed leukoreduced irradiated blood cell transfusions<br>* washed leukoreduced irradiated blood cell transfusions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio | 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. | 12 hours post-cardiopulmonary bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median wrCRP Level | wide range C reactive protein levels were obtained before surgery (pre-operatively) and on post-operative day 1 and 2 in transfused subjects | post op day 1 and 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, congenital heart disease