A Comparison Between 5% Albumin and 6% Hydroxyethyl Starch 130/0.4 in Priming Solution for Cardiopulmonary Bypass and Post-bypass Maintenance Fluid in High-risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Effect of 6% hydroxyethyl starch 130/0.4 as a priming solution on coagulation and blood loss following complex heart valve surgery: a comparison with 5% albumin
研究概览
简要总结
It is advantageous to use 5% human albumin (HA) in patients undergoing cardiopulmonary bypass (CPB), because preexposure of the synthetic surfaces of the CPB circuit to albumin decreases coagulopathy, platelet aggregation, immune responses. However the use of albumin is limited, because it is expensive and can rarely cause infection.
Hydroxyethyl starch (HES) decreases clot strength and prolong clot formation. A recently developed 6% HES 130/0.4 is known to have fewer effects on hemostasis. However Schramlo AA et al. reported that short time infusion of HES 130/0.4 after cardiac surgery produced impairment in fibrin formation and clot strength in thromboelastometry tracings.
Coagulopathy is directly related to bleeding and massive postoperative bleeding increases the risk of reoperation. Therefore it is important to avoid administration of fluids that can inhibit homeostasis after CPB.
The purpose of this study is to investigate the effect of 6% HES 130/0.4 as a component of priming solution on coagulation compared to 5% HA.
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
- Triple (Participant, Investigator, 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
- 否
入选标准
- •patients who have uncontrolled medical problems, life-threatening cardiac disease, complex cardiac surgery, or emergency operation
排除标准
- •patients who had received warfarin, heparin, acetylsalicylic acid, or antiplatelet drug within 5 days before surgery
研究组 & 干预措施
HA (priming)-HES (up to 15 ml/kg after CPB)
干预措施: Hydroxyethyl starch 130/0.4 (Drug)
HES (priming)-HES (up to 15 ml/kg after CPB)
干预措施: Hydroxyethyl starch 130/0.4 (Drug)
HA (priming)-nonHES (only crystalloids after CPB)
干预措施: Hydroxyethyl starch 130/0.4 (Drug)
结局指标
主要结局
Effect of 6% hydroxyethyl starch 130/0.4 as a priming solution on coagulation and blood loss following complex heart valve surgery: a comparison with 5% albumin
时间窗: upto 24hours after cardiopulmonary bypass
The purspose of this study is to investigate the effect of 6% HES 130/0.4 as a component of priming solution on coagulation compared to 5% HA. Rotation thromboelastography (ROTEM) was performed before and 24 h after CPB. Hemoglobin, platelet count and transfusion requirement were assessed for 24 h postoperatively.
次要结局
未报告次要终点