Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- change in clotting time - CT (%)
研究概览
简要总结
Therapeutic plasma exchange is widely performed in patients with autoimmune disease. The exact effects of fresh frozen plasma on coagulation in this group of patients remains unknown. In order to investigate this issue the present study monitors periprocedural coagulation status with the aid of standard coagulation tests and rotational thromboelastometry. Four thromboelastometric tests will be performed: ExTEM, InTEM, FibTEM and ApTEM. The following parameters will be recorded from each test: CT (sec), CFT (sec) and MCF (mm) one hour before and one hour after plasmaechange was performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Minutes 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing therapeutic plasma exchange for autoimmune disease
排除标准
- •previous coagulation disorders
- •anticoagulant or antiplatelet therapy within the last 7 days
结局指标
主要结局
change in clotting time - CT (%)
时间窗: one hour before compared to one hour after plasmaexchange
change in CT determined before and after plasmaexchange. A 20% change in parameter value will be considered clinically significant.
次要结局
- change maximum clot firmness - MCF (%)(one hour before compared to one hour after plasmaexchange)
- change clot formation time - CFT (%)(one hour before compared to one hour after plasmaexchange)
研究者
Popescu Mihai
Clinical Professor
Institutul Clinic Fundeni