Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- treatment time
研究概览
简要总结
The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing cardiac surgery
排除标准
- •thrombocytopenia
- •oral anti-coagulant
- •anti platelet agents
研究组 & 干预措施
fresh frozen plasma
according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, fresh frozen plasma transfusion (FFP) 10-15 ml/kg is performed
干预措施: fresh frozen plasma (Biological)
prothrombin complex concentrate
according to the Rotational thromboelastometry (ROTEM) test, CT-EXTEM prolongation, prothrombin complex concentrate (PCC) 10-15 IU/kg is administered
干预措施: prothrombin complex concentrate (Biological)
结局指标
主要结局
treatment time
时间窗: 1 min
duration from the time of diagnosing CT-EXTEM prolongation (ordering PCC or FFP) to the time achieving bleeding control (completing administration of PCC or FFP)
次要结局
- MA-EXTEM(10 min)
- MA-FIBTEM(10 min)
- Red Blood Cell amount(I hour)
- Postoperative bleeding(24 hour)
- FFP amount(1 hour)
- Platelet amount(1 hour)
- CT-EXTEM(10 min)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center