Procedure to Define a Normal Reference Range Using the TEG® 6s Diagnostic System With the Heparin Neutralization Cartridge in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 3
- 主要终点
- CKH-MA TEG Parameter
研究概览
简要总结
This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.
Written consent to participate in the study will be obtained prior to volunteer screening per site procedures.
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
- 是
入选标准
- •Adult volunteers (18 years of age and older) who self-identify as being in general good health.
排除标准
- •Volunteers with any acute illness or uncontrolled chronic disease
- •Volunteers with any type of cancer
- •Volunteers with diabetes
- •Volunteers with renal disease
- •Volunteers with liver disease
- •Volunteers with morbid obesity
- •Volunteers with autoimmune or inflammatory diseases
- •Volunteers with known coagulation and/or bleeding disorders (e.g., hemophilia, Von Willebrand's disease)
- •Volunteers currently abusing alcohol (defined as more than 3 drinks for women and more than 4 drinks for men on any given day, or 7 drinks for women and 14 drinks for men throughout the week) or taking illicit drugs
- •Volunteers with hereditary fibrinolytic bleeding disorders
- •Volunteers with altered coagulation due to the presence of direct oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran) in the blood
- •Volunteers on any fibrinolytic activators (e.g., Streptokinase, t-PA, Reteplase, Tenecteplase, Urokinase, APSAC, Staphylokinase)
- •Volunteers who have had recent surgery (within the last four weeks)
- •Volunteers with any injuries leading to substantial bleeding or bruising (within the last two weeks prior to blood donation)
- •Volunteers with bruising, wounds, or scarring around the selected venipuncture site
- •Volunteers deemed unfit for participation in the trial by the principal investigator
- •Volunteers participating in another clinical trial that would not be scientifically or medically compatible with this trial
- •Volunteers who have been on P2Y12 inhibitors within the last 30 days
- •Volunteers receiving treatment with low molecular weight heparin (e.g., enoxaparin)
- •Volunteers with altered coagulation due to the presence of drugs known to affect the coagulation status in the blood (see Table 1)
- •Volunteers who have participated in this trial previously
结局指标
主要结局
CKH-MA TEG Parameter
时间窗: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Citrated Kaolin with Heparinase Maximum Amplitude Thromboelastographic Result
CKH-LY30 TEG Parameter
时间窗: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was percentage.
Citrated Kaolin with Heparinase Lysis Thromboelastographic Result
CFFH-MA TEG Parameter
时间窗: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result
CKH-R TEG Parameter
时间窗: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
Citrated Kaolin with Heparinase Reaction Time Thromboelastographic Result
CRTH-MA TEG Parameter
时间窗: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Citrated Rapid TEG with Heparinase Maximum Amplitude Thromboelastographic Result
CK-R TEG Parameter
时间窗: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was minutes.
Citrated Kaolin Reaction Time Thromboelastographic Result
CK-MA TEG Parameter
时间窗: Outcome measure from the single blood draw was assessed within 2 hours of blood draw. Unit of measurement was mm.
Citrated Kaolin Maximum Amplitude Thromboelastographic Result
次要结局
未报告次要终点