Impact on Anticoagulation Management When Activated Clotting Time is Combined With Heparin Concentration Monitoring in Cardiac Surgery: a Randomised Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Heparin dose
研究概览
简要总结
The goal of this clinical trial is to compare the anticoagulation management with or without heparin concentration level guidance, in patients undergoing valve or complex cardiac surgery during cardiopulmonary bypass using closed, coated circuits. The main questions it aims to answer are:
- initial heparin bolus, subsequent supplementary doses and total heparin variance among groups.
- protamine dose among groups.
Participants are adult patients scheduled for valve or complex cardiac surgery. They are randomised to either Activated Clotting Time guided management alone or combined with heparin level concentration monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •elective procedures
- •cardiac surgery, except for Coronary Artery Bypass Grafting
- •Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation
排除标准
- •known allergy to heparin or protamine
- •hematological disease
研究组 & 干预措施
Activated Clotting Time (ACT)
In this group, only ACT measurements and fixed doses of heparin and protamine are administered.
ACT is measured using the ACT Plus device (Medtronic, MN, USA). Heparin formulation administered is HEPARIN/LEO INJ.SOL 25000IU/5ML. Protamine formulation administered is PROTAMINE SULPHATE/LEO PHARMA 10mg/ml
干预措施: Activated Clotting Time (Other)
Heparin Concentration (HC)
In this group, the Hepcon HMS Plus (Medtronic, MN, USA) is used to perform heparin concentration calculations and test each patient's individual response to heparin. Specifically tests performed were:
- Heparin Dose Response test
- Heparin Assay test
干预措施: Activated Clotting Time measurements combined with heparin concentration monitoring (Other)
结局指标
主要结局
Heparin dose
时间窗: Total dose after cardiopulmonary bypass
Heparin dose, IU
Protamine dose
时间窗: Total dose after cardiopulmonary bypass
Protamine dose, mg
Heparin dose
时间窗: Bolus dose before cardiopulmonary bypass
Heparin dose, IU
次要结局
- Platelet count(48 hours after surgery)
- Platelet count(Immediately after surgery)
- Platelet count(24 hours after surgery)
研究者
Anna Gkiouliava
Principal Investigator
Aristotle University Of Thessaloniki