Prediction of Bleeding Outcomes / Transfusion Requirements and Assessment of Perioperative Changes in Platelet Reactivity Using Point-of-care Platelet Function Testing in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- postoperative chest tube output
研究概览
简要总结
Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent problem. Antiplatelet therapy (APT) is an integral component of perioperative management in patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early postoperative bleeding extent and transfusion requirements remains difficult to predict.
In addition to, resistance to antiplatelet drugs as well as perioperative increase in platelet reactivity following CPB has been reported but this phenomenon has to be comprehensively investigated.
The best point-of-care platelet function test to predict bleeding complications/transfusion requirements remains unclear. In addition to, the best test platelet function test to monitor resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive.
The aim of this study is:
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to prediction of bleeding complications/trasfusion requirements.
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to detection of high "on-treatment" platelet reactivity both pre- and postoperatively.
详细描述
Excessive bleeding after cardiopulmonary bypass (CPB) operations remains to be a persistent problem. Antiplatelet therapy (APT) is an integral component of perioperative management in patients undergoing cardiac surgery. The impact of drug induced platelet inhibition on early postoperative bleeding extent and transfusion requirements remains difficult to predict.
In addition to, resistance to antiplatelet drugs as well as perioperative increase in platelet reactivity following CPB has been reported but this phenomenon has to be comprehensively investigated.
The best point-of-care platelet function test to predict bleeding complications/transfusion requirements remains unclear. In addition to, the best test platelet function test to monitor resistance to antiplatelet therapy and its impact on clinical outcomes remains elusive.
The aim of this study is:
- to compare two point-of-care platelet function analyzers (Multiplate and ROTEM Platelet) in regard to prediction of bleeding complications/trasfusion requirements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old
- •Elective cardiac surgery patients
- •Coronary artery disease
- •Aortic valve disease
- •Mitral valve disease
- •Ascendent aorta aneurysm
- •Combine coronary and valve disease
- •Cardiac surgery procedures using cardiopulmonary bypass
排除标准
- •Missing consent
- •Patients with emergent cardiac surgical procedures
- •Patients on antiplatelet therapy other than aspirin , clopidogrel and prasugrel
- •Patients with inaccurate antiplatelet therapy administration documentation
- •Missing data
- •Off-pump procedures
- •Patients younger than 18 years old
- •Patients with severe mental disorders
- •Intrinsic coagulopathy
结局指标
主要结局
postoperative chest tube output
时间窗: the first 24 postoperative hours
Chest tube output (CTO) was determined as study's primary outcome. To estimate blood loss, we will meticulously document CTO, in first 24 postoperative hours and divide it by patient's weight. Drainage loss will be assessed after completion of a 30-minute stabilization period. Blood loss during the stabilization period will not be included in the definition of postoperative hemorrhage. Such loss may be caused by postural changes when transferring the patient from the operating room table to the bed or because of fluid in the pleural or mediastinal cavity, which may have arisen from the rinsing with water as an attempt to achieve surgical hemostasis.
次要结局
- Transfusion requirements(5 days)
- reexploration for bleeding(3 days)
研究者
Petricevic Mate
M.D. , Ph.D.
University of Zagreb