Heparin and Protamine Titration Using Optical Detection Technology in Patients Undergoing Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Total heparin dose
研究概览
简要总结
During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. In this prospective clinical study the researchers will investigate the impact of the two different methods to calculate the required dosage of heparin and protamine; the individualized calculation computed by the Hemostasis Management System Plus (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators hypothesize that the aforementioned methods result in different dosages and will elaborate on their impact on postoperative bleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •elective cardiac surgery under cardiopulmonary bypass
排除标准
- •known blood disorder
- •contraindication to heparin administration
研究组 & 干预措施
Individualized heparin and protamine titration
The device Hemostasis Management System Plus (Medtronic, Minneapolis, MN) will be used to determine the patients' sensitivity to heparin and its concentration in whole blood. Then, it will automatically calculate the necessary dose for anticoagulation during bypass. The protamine dose to eliminate heparin effect will be calculated from the remaining heparin concentration (0.75mg/100 International Units circulating heparin).
干预措施: Hemostasis Management System Plus (Device)
Activated Clotting Time guided heparin and protamine dose
Heparin initial dose will be determined according to the patients' weight to achieve a required Activated Clotting Time (ACT) to initiate cardiopulmonary bypass. Subsequent doses of heparin will be administered according to ACT and protamine dose will be calculated from total heparin dose (0.75mg protamine/100 International Units heparin)
干预措施: Activated Coagulation Timer System Plus (Device)
结局指标
主要结局
Total heparin dose
时间窗: operation duration
Heparin dose measured in IU
Total protamine dose
时间窗: At the end of the cardiopulmonary bypass
Protamine dose measured in mg
次要结局
- Red Blood Cells transfusion(24 hours after the end of the operation)
- Fibrinogen concentrate transfusion(24 hours after the end of the operation)
- Prothrombin Complex Concentrate transfusion(24 hours after the end of the operation)
- Platelets transfusion(24 hours after the end of the operation)
- Red Blood Cells transfusion(intraoperatively)
- Fibrinogen concentrate transfusion(intraoperatively)
- Prothrombin Complex Concentrate transfusion(intraoperatively)
- Platelets transfusion(intraoperatively)
研究者
Anna Gkiouliava
PhD candidate
Aristotle University Of Thessaloniki