The Effect of a Palonosetron on Blood Coagulation: In Vitro, Volunteer Study Using Thromboelastography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Citrated Functional Fibrinogen
研究概览
简要总结
Palonosetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of palonosetron. The investigators therefore will perform the present study to measure the effect of palonosetron levels using thromboelastography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Age: 20 to 65 years
- •Body weight > 50 kg
- •Volunteers who provided informed consent
排除标准
- •Hematologic disease
- •Anticoagulant medication
研究组 & 干预措施
0 ng/ml
Blood specimen which was added of 0 ul of palonosetron
干预措施: 0 ul of palonosetron (Drug)
25 ng/ml
Blood specimen which was added of 1 ul of palonosetron
干预措施: 1 ul of palonosetron (Drug)
250 ng/ml
Blood specimen which was added of 10 ul of palonosetron
干预措施: 10 ul of palonosetron (Drug)
2500 ng/ml
Blood specimen which was added of 100 ul of palonosetron
干预措施: 100 ul of palonosetron (Drug)
结局指标
主要结局
Citrated Functional Fibrinogen
时间窗: During the thromboelastography analysis/ an average of 1 hour
Provides clot strength based on fibrinogen contribution
次要结局
- Citrated Kaolin(During the thromboelastography analysis/ an average of 1 hour)
- Citrated Kaolin Heparinase(During the thromboelastography analysis/ an average of 1 hour)
- Citrated Rapid Thromboelastography(During the thromboelastography analysis/ an average of 1 hour)
- Heparinized Kaloin Heprinase(During the thromboelastography analysis/ an average of 1 hour)
- Activator F(During the thromboelastography analysis/ an average of 1 hour)
- Adenosine diphosphate(During the thromboelastography analysis/ an average of 1 hour)
- Arachidonic acid(During the thromboelastography analysis/ an average of 1 hour)
研究者
Hyo-Seok Na
Professor
Seoul National University Bundang Hospital