Washed Versus Standard Blood Cell Transfusions in Pediatric Open Heart Surgery
|ClinicalTrials.gov Identifier: NCT00693498|
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : November 29, 2012
Last Update Posted : January 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Biological: Standard leukoreduced irradiated blood cell transfusion Biological: Washed leukoreduced irradiated blood cell transfusions||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Active Comparator: 1
Standard leukoreduced irradiated blood cell transfusion group
Biological: Standard leukoreduced irradiated blood cell transfusion
standard vs washed blood cell transfusions
Washed leukoreduced irradiated blood cell transfusion group
Biological: Washed leukoreduced irradiated blood cell transfusions
washed leukoreduced irradiated blood cell transfusions
- 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio [ Time Frame: 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.
- Median wrCRP Level [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693498
|Principal Investigator:||Jill Cholette, MD||University of Rochester|