Normal Values and Quality Assessment of Light Transmission Aggregometry (LTA) Using Aggregometer TA-8V (Stago®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Platelets aggregation results for LTA on TA-8V (Stago®)
研究概览
简要总结
Exploring platelet functions requires aggregation tests platelet. The Haematology Laboratory of Hospices Civils de Lyon currently has two new TA-8V plate aggregation automatons® (Stago).
The supplier of these devices does not offer reference values for these tests. There are also no references in the data literature. Therefore reference values must be established from healthy volunteer subjects.
The use of these automatons is subject to the NF (French Standard) EN (European Standard) ISO (International Organization for Standardization) 15189 standard of the COFRAC ( French Accreditation Comity) that requires checking their proper functioning. This audit must be traced in a method validation folder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults aged between 18 and 70 years
- •Weighting more than 50 kg
- •Subjects having signed informed consent
- •Subjects registered in the French health-care system database
排除标准
- •Personal history of anemia, thrombopenia, hemorrhagic disease
- •Caffeine intake 2 hours prior to blood sampling
- •Tobacco intake in the half hour prior to blood sampling
- •Use of any drug impacting platelet function
- •for antiplatelet agents: at least 10 days prior to blood sampling
- •for anti-depressants: at least 10 days prior to blood sampling
- •for non-steroid anti-inflammatories: at least 3 days prior to blood sampling
- •Refusal to undergo the 3 visits and 3 blood samples of the study
- •Refusal to sign the informed consent form
- •No registration in the French Health-care system database
- •Pregnant women and women who are breastfeeding
研究组 & 干预措施
30 healthy adult volunteers
Healthy adult volunteers without hemorrhagic diathesis.
干预措施: Take blood (TA-8V (Stago®) (Device)
结局指标
主要结局
Platelets aggregation results for LTA on TA-8V (Stago®)
时间窗: Month 6
Normal values for platelets aggregation will be established using various agonists to activate platelets. : * Epinephrine (STAGO®) * PMA (phorbol 12-myristate 13 acetate) (SIGMA®) * PAF (Platelet Activator Factor) (BACHEM®) * Ionophore calcium (SIGMA®) * 11-Epoxy (SIGMA®) * Prostaglandin E1 (SIGMA®)
Platelets aggregation results for LTA on TA-8V (Stago®)
时间窗: Month 0
Normal values for platelets aggregation will be established using various agonists to activate platelets. : • Ristocetin (STAGO®)
Platelets aggregation results for LTA on TA-8V (Stago®)
时间窗: Month 3
Normal values for platelets aggregation will be established using various agonists to activate platelets. : * Collagen (STAGO®) * ADP (adenosine diphosphate) (STAGO®) * Arachidonate (STAGO®) * TRAP (Thrombin Receptor Activating Platelet) (STAGO®)
次要结局
- Agonist reagents stability duration(up to 2 months post reagents reconstitution)
- LTA inter operator variability(Month 6)
- LTA intra assay variability(Month 6)
- LTA inter operator variability(Month 3)
- LTA intra assay variability(Month 0)
- LTA intra assay variability(Month 3)
- LTA inter operator variability(Month 0)
- Agonist reagents stability duration(up to 2 months post reagents reconstitution and 2 months post reconstitution with the same technician, the same automaton and the same healthy volunteer sample.)