Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of the sensitivity of several thromboplastin reagents of different origins (animal, human synthetic recombinant and human placental extraction) on prothrombin time and factor II, V, VII and X assays.
研究概览
简要总结
Primary purpose :
Compare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor II, V, VII and X assays in two different populations of patients :
- Patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor II or V or VII or X.
- Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment).
Results of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors II, V, VII, X assays. This work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory/center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Plasma samples from patients addressed to the laboratory of the Strasbourg University Hospital (Strasbourg France) collected and anonymized after completion of the routine testing.
- •Patient with an isolated or combined extrinsic pathway factor deficiency (factor II, V, VII, X).
排除标准
- •Patient treated with an oral anticoagulant treatment.
- •Patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).
研究组 & 干预措施
Hepatocellular insufficiency with coagulopathy
Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment).
干预措施: Prothrombin time (Biological)
Isolated extrinsic pathway factor deficiency
Patients with an isolated extrinsic pathway factor deficiency (acquired or congenital) : II or V or VII or X
干预措施: Prothrombin time (Biological)
结局指标
主要结局
Comparison of the sensitivity of several thromboplastin reagents of different origins (animal, human synthetic recombinant and human placental extraction) on prothrombin time and factor II, V, VII and X assays.
时间窗: Plasma samples were frozen at -80°C within 3 hours of collection and were serially analyzed few weeks later by thawing at 37°C within 2 hours after thawing.
次要结局
未报告次要终点