NCT06352125已完成不适用
An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 7
- 主要终点
- Primary Method Comparison
研究概览
简要总结
This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients who are at an increased risk of intervention-induced coagulopathy or at increased risk of developing intervention-induced coagulopathy complications undergoing cardiovascular surgeries or liver transplantation (recipients):
- •Adult patients (18 years of age and older) who underwent cardiovascular on-pump surgeries or procedures (e.g., CABG) who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or
- •Adult patients (18 years of age and older) who underwent not-on-pump cardiovascular surgeries (e.g., lead extraction) or cardiovascular procedures (e.g., minimally invasive valve or percutaneous cardiac procedures, such as PCI, LAAC, TAVR/TAVI) associated with the use of heparin who were at an increased risk of coagulopathy-related complications1 (see Table 9.3-1) as well as patients with clinically apparent or suspected coagulopathy or
- •Adult patients (18 years of age and older) who underwent liver transplantation (recipients)
排除标准
- •Patients with hereditary chronic coagulation and/or bleeding disorders
- •Patients with hereditary fibrinolytic bleeding disorders
- •Patients deemed unfit for participation in the by the principal investigator
- •Patients participating in another clinical that would not be scientifically or medically compatible with this trial
- •Patients with currently altered coagulation due to the presence of oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran, warfarin)
结局指标
主要结局
Primary Method Comparison
时间窗: Outcome measure from the single blood draw was assessed within 2 hours of blood draw.
CKH-LY30 TEG Parameter. Unit of measurement was percentage.
次要结局
未报告次要终点
研究者
研究点 (7)
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