Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Results of lupus anticoagulant testing: positive or negative
研究概览
简要总结
The aim is to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.
详细描述
Citrated whole blood was collected from subjects with positive lupus anticoagulant (LA) testing and from subjects with negative LA testing. Injectable anticoagulants were prepared in demineralized water and added to plasma samples LA+ and LA- to obtain broad anti-Xa activity ranges. Anti-Xa measurement and LA testing were performed in neat and spiked plasma samples. LA testing was performed with 4 different analyzer-reagent combinations to represent almost all hemostasis manufacturers currently available. There will be no direct comparison between the LA+ and LA- groups, the objective is to evaluate the effect of increasing concentrations of injectable anticoagulants on these 2 distinct populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Patients are recruited according to their LA status (LA- or LA+).
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
- •For all subjects:
- •Adult male or female subject.
- •In capacity to give informed consent to participate in the research.
- •Affiliated to a Social Security system.
- •For the LA- group:
- •Without a previous thrombosis and considered healthy on the basis of the interview and clinical examination.
- •Without coagulation disease
- •For the LA+ group:
- •Notion of the presence of lupus anticoagulant (according to ISTH criteria) and whose last test was positive.
排除标准
- •For all subjects:
- •Medical history considered by the investigator to be incompatible with the trial
- •Refused participation
- •Recent administration of oral or injectable anticoagulants
- •INR > 1.5
- •Pregnant women, nursing mothers
- •Guardianship, curatorship, deprived of liberty, safeguard of justice
结局指标
主要结局
Results of lupus anticoagulant testing: positive or negative
时间窗: day 1
Concerning the impact of injectable anticoagulants on the final diagnosis of LA testing (negative or positive), in a population of LA+ and LA- subjects, particular attention will be paid to the study of false negatives and false positives expressed in % and 95% confidence intervals.
次要结局
- Effect of injectable anticoagulants on the clotting times of each of the tests involved in LA testing (detection, mixing and confirmation tests).(day 1)
- Determination of the threshold limits of injectable anticoagulants (anti-Xa activities) allowing a reliable LA diagnosis, for each analytical solution tested (analyzer/reagent combinations).(day1)