Evaluation of the Feasibility of Rotational Thromboelastrometry During Cardiopulmonary Bypass Using a Heparinase Modified ROTEM® Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline ROTEM® measurements after the administration of heparin
研究概览
简要总结
Coagulopathy with transfusion requirements is frequent during cardiac surgery with cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood point of care test used to assess the patient's coagulation status.
The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high heparin concentrations as seen during cardiopulmonary bypass.
详细描述
The Society of Cardiothoracic surgeons suggest that 50% of patients undergoing cardiac surgery have a blood transfusion.
Several studies indicate an increase in morbidity and mortality related to blood transfusions.
Traditionally, the coagulation tests are performed in the hematology laboratory.
Rotational thromboelastrometry is a useful method of assessing perioperative coagulation function in patients undergoing cardiac surgery.
The presence of significant amounts of heparin in blood samples during cardiopulmonary bypass induces artifactual errors when thromboplastin is used as a reagent. For this reason, whole blood coagulation monitoring with ROTEM® has not been feasible during cardiopulmonary bypass with heparin anticoagulation. Recently recombinant thromboplastin has come available. It's stability is guaranteed by the manufacturer for plasmatic heparin concentrations up to 5UI/l .
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ungergoing coronary artery bypass grafting using cardiopulmonary bypass
- •Patients from 18 to 85 years old.
排除标准
- •Patients incapable to consent.
- •Known coagulopathies or platelet dysfunction.
- •Patients treated with antiplatelet drugs other than aspirin.
- •Patients treated with anti vitamine K anticoagulants.
- •Patients treated with heparin less than 6 hours prior to surgery.
结局指标
主要结局
Change from baseline ROTEM® measurements after the administration of heparin
Baseline ROTEM® measurement will be compared to ROTEM® measurements after the administration of heparin, at the end of cardiopulmonary bypass and after the administration of protamine.
次要结局
未报告次要终点