Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Non-Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 154
- 主要终点
- duration from the time diagnosing r-time prolongation to the time achieving bleeding control
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 non-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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing spine surgery
- •patients undergoing open radical prostatectomy
- •patients undergoing hip arthroplasty
- •patients undergoing knee arthroplasty
排除标准
- •Patients taking oral anticoagulants,
- •Patient taking recombinant factor VII a
- •pregnancy
研究组 & 干预措施
fresh frozen plasma
according to the Thromboelastography (TEG) test, CK r-time prolongation, fresh frozen plasma transfusion (FFP) is performed
干预措施: fresh frozen plasma (Biological)
prothrombin complex concentrate
according to the Thromboelastography (TEG) test, CK r-time prolongation,prothrombin complex concentrate (PCC) administration
干预措施: prothrombin complex concentrate (Biological)
结局指标
主要结局
duration from the time diagnosing r-time prolongation to the time achieving bleeding control
时间窗: 1 min
次要结局
- r-time(10 min)
- Bleeding(6 hour)
- oxygenation profile(1 hour)
- Red Blood Cell amount(1 hour)
- FFP amount(1 hour)
- CRT-MA(10 min)
- CFF-MA(10 min)
- Platelet amount(1 hour)
研究者
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center