Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Biological: Standard leukoreduced irradiated blood cell transfusion; Biological: Washed leukoreduced irradiated blood cell transfusions

• Registration Number: NCT00693498
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Study Start: 2008-07
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2011-11-30
• Results First Submitted QC: 2012-11-28
• Results First Posted: 2012-11-29
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard leukoreduced irradiated blood cell transfusion	Standard leukoreduced irradiated blood cell transfusion group
2	Washed leukoreduced irradiated blood cell transfusions	Washed leukoreduced irradiated blood cell transfusion group

Primary Outcome Measures

Name	Time	Method
12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio	12 hours post-cardiopulmonary bypass	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

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