Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Clotting time (CT) in EX-test and EXTEM
研究概览
简要总结
The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.
详细描述
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our emergency department for trauma from the 1st of October 2019 to the 31st of January 2020 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Viscoelastic tests of coagulation will be performed on ROTEM® Delta and ClotPro® simultaneously. We will compare values of clotting time (CT), clot formation time (CFT), alfa angle, maximum clot firmness (MCF) and maximum lysis (ML) for test of extrinsic pathway(EX-test) on ClotPro® vs. test for extrinsic pathway (EXTEM) on ROTEM® Delta. Further we will compare values of clotting time (CT), clot formation time (CFT), alfa angle, maximum clot firmness (MCF) and maximum lysis (ML) for thromboelastometry of fibrinogen (FIB-test) on ClotPro® vs. thromboelastometry of fibrinogen (FIBTEM) on ROTEM® Delta. The secondary outcome will be to describe the dependence of measurement on temperature of patient.
Study data will be entered in study form. The measurements can be repeated in time. The indication for next measurement is fully on treating physician.
Differences in estimated viscoelastic coagulation parameters and interchangeability of two devices will be analysed.
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 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •polytrauma with Injury severity score ≥ 16
排除标准
- •pregnancy
- •anticoagulant therapy
- •antiplatelet therapy
- •coagulation disorders
结局指标
主要结局
Clotting time (CT) in EX-test and EXTEM
时间窗: through study completion, an average of 3 months
difference in clotting time measured by EX-test and EXTEM
clotting time (CT) FIB-test and FIBTEM
时间窗: through study completion, an average of 3 months
difference in clotting time measured by FIB-test and FIBTEM
alfa angle in EX-test and EXTEM
时间窗: through study completion, an average of 3 months
difference in alfa angle measured by EX-test and EXTEM
maximum clot firmness (MCF) in EX-test and EXTEM
时间窗: through study completion, an average of 3 months
difference in maximum clot firmness measured by EX-test and EXTEM
clot formation time (CFT) FIB-test and FIBTEM
时间窗: through study completion, an average of 3 months
difference in clot formation time measured by FIB-test and FIBTEM
alfa angle FIB-test and FIBTEM
时间窗: through study completion, an average of 3 months
difference in alfa angle measured by FIB-test and FIBTEM
maximum lysis (ML) FIB-test and FIBTEM
时间窗: through study completion, an average of 3 months
difference in maximum lysis measured by FIB-test and FIBTEM
Clot formation time (CFT) in EX-test and EXTEM
时间窗: through study completion, an average of 3 months
difference in clot formation time measured by EX-test and EXTEM
maximum lysis (ML) in EX-test and EXTEM
时间窗: through study completion, an average of 3 months
maximum lysis difference in MCF measured by EX-test and EXTEM
maximum clot firmness (MCF) FIB-test and FIBTEM
时间窗: through study completion, an average of 3 months
difference in maximum clot firmness measured by FIB-test and FIBTEM
次要结局
- maximum clot firmness (MCF) FIBTEM and Clauss method(through study completion, an average of 3 months)
- maximum clot firmness (MCF) FIB-test and Clauss method(through study completion, an average of 3 months)
- patient temperature(through study completion, an average of 3 months)