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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 主要终点
- 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
1
Standard leukoreduced irradiated blood cell transfusion group
干预措施: Standard leukoreduced irradiated blood cell transfusion (Biological)
2
Washed leukoreduced irradiated blood cell transfusion group
干预措施: Washed leukoreduced irradiated blood cell transfusions (Biological)
结局指标
主要结局
12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio
时间窗: 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.
次要结局
- Median wrCRP Level(post op day 1 and 2)
研究者
Jill Cholette
Assistant Professior
University of Rochester