Blood Cell Adhesion to Arterial Filters During Cardic Surgery - Observational Clinical Study: Scanning Electron Microscopy and Cell Gene Expression Analysis
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Types and characteristics of materials entrapped in the arterial line filter of cardiopulmonary bypass
研究概览
简要总结
Cardiopulmonary bypass (CPB) is a unique clinical scenario that results in widespread activation of the hemostatic system. Conventional CPB interferes with normal hemostasis by diluting hemostatic cells and proteins, through reinfusion of shed blood, and through activation on the bypass circuit surface of multiple systems including platelets, the kallikrein-kinin system, and fibrinolysis . Besides, deleterious effects of cardiopulmonary bypass (CPB) are partly sequelae of blood-foreign surface reactions. The arterial filter is the part of the CPB circuit where blood cells are exposed to high mechanical stress and where cellular aggregates may fasten in large quantitiesiec.
详细描述
This is a clinical and observational study. It is being performed in the surgical center and intensive care unit of the Heart Institute (InCor) from Faculty of Medicine, University of São Paulo (FMUSP), on patients undergoing cardiac surgery, who satisfy inclusion and exclusion criteria. In the preanesthetic visit, patient assessment of the criteria described in study methodology is verfied. During the surgery, a blood sample is taken to analyze hemostatic function in the begin of cardiopulmonary bypass, before arterial filter (pre-filter) and in the end of cardiopulmonary bypass, after arterial filter (post-filter). Other routine laboratory exams is being colected until first postoperative day, on the eletronic medical records. At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM. Ten arterial filter samples from pre-determined sites and sizes are sent to the clinical laboratory for evaluation of platelet and leukocyte gene expression in arterial filter. Patients will be followed until hospital discharge or 28 days after surgery, regarding allogeneic transfusion needs, reoperation and thromboembolic events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgeries with extracorporeal circulation in patients older than 18 years
- •Written and signed informed consent
- •Preanesthetic assessment and preoperatory exams in accordance with study methodology
排除标准
- •Active infection;
- •Previously coagulopathy;
- •Antiplatelet therapy use until 10 days before surgery (except acetylsalicylic acid and enoxaparin that may be used in prophylactic doses until 24h before surgery);
结局指标
主要结局
Types and characteristics of materials entrapped in the arterial line filter of cardiopulmonary bypass
时间窗: At the beginning and end of cardiopulmonary bypass
Analysis of the arterial filter from cardiopulmonay bypass circuit by scanning electron microscopy (SEM)
Platelet and leukocyte gene expression analysis of arterial line filters of cardiopulmonary bypass
时间窗: At the beginning and end of cardiopulmonary bypass
Arterial filter samples from predetermined sites and sizes will be analyzed for evaluation of platelet and leukocyte gene expression in arterial filter.
次要结局
- Correlation between blood adhesion cells in arterial filter and coagulation tests(At the beginning and end of cardiopulmonary bypass)
- Comparison of standard coagulation test(At the beginning and end of cardiopulmonary bypass, Immediate postoperative; 24 hours and 48 hours after surgery)
- Comparison of free oscillation rheometry profile(At the beginning and end of cardiopulmonary bypass)
研究者
Filomena R B G Galas
Associate Professor of Anesthesiology at University São Paulo Medical School
Instituto do Coracao