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临床试验/NCT04299828
NCT04299828招募中不适用

Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Serum GABA and pro-inflammatory cytokines

研究概览

简要总结

The goal of this proposal is to prospectively collect data from a series of 200 patients (all ages) undergoing complex cardiac surgical procedures involving cardiopulmonary bypass (CPB) to:

  1. Measure the number of blood activated circulating monocytes before, during and after cardiac surgery and serum GABA and pro-inflammatory cytokine levels
  2. Understand the correlation between GABA and inflammatory cytokines (and/or activated monocytes) and
  3. Assess the correlation between thrombosis and monocyte activation in patients undergoing cardiac surgery under CPB and at risk of thrombosis.

详细描述

Often when people undergo heart surgery, they are placed on cardiopulmonary bypass (CPB). Sometimes clotting of the blood occurs during and after heart surgery with CPB, which can lead to multiple complications. In order to try to avoid abnormal/excessive clotting that may lead to complications, it is important to understand the specific causes of why the blood sometimes clots abnormally during and after heart surgery.

Currently, tests looking at how the blood clots (coagulation assessment) are usually performed as standard laboratory testing during and after surgery. However, these tests are not able to predict the future development of abnormal clots.

This study will be looking at the role that immune cells (monocytes) have in the formation of abnormal clots after heart surgery. It is possible that these immune cells produce signals that can contribute to the formation of clots. Using experimental tests (monocyte analysis and mediator analysis), the hope is to understand if these cells participate in forming abnormal clots in any meaningful way. Although these tests are not yet approved for use in children, this study plans to use these new methods to understand this phenomenon by analyzing the blood at different times during the surgery and recovery period.

Overall, the purpose of this study is to look at these tests in people undergoing heart surgery to help the investigators understand why the blood sometimes forms clots abnormally. Results from this study may help treat future patients who experience abnormal clotting during and after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients (all ages) undergoing complex cardiac surgical procedures with CPB.

排除标准

  • •undergoing an emergent procedure and do not have more than 1 hour ahead of time to review the consent
  • •patient in a moribund condition American Society of Anesthesiology (ASA 5) -patient with a hematological and/or oncological disease
  • •Jehovah witnesses.

结局指标

主要结局

Serum GABA and pro-inflammatory cytokines

时间窗: Through study completion; on average one year

Serum GABA and pro-inflammatory cytokines

Monocyte activation status

时间窗: Through study completion; on average one year

characterization of monocyte activation status at baseline before surgery and throughout the course of CPB including post-operatively.

次要结局

  • Clinical Thrombosis(Through study completion; on average one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Koichi Yuki

Cardiac Anesthesiologist

Boston Children's Hospital

研究点 (2)

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