Anti Xa Blood Levels at Survivors of Acute Ischemic Stroke- Receiving LMWH-VTE Prophylaxis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anti-Xa level
研究概览
简要总结
The anti-factor Xa (anti-Xa) assay is a functional assay that facilitates the measurement of antithrombin (AT)-catalyzed inhibition of factor Xa by unfractionated heparin (UFH) and direct inhibition of factor Xa by low-molecular-weight heparin (LMWH). As a result, Anti-factor Xa level reflect the in situ pharmacological activity of LMWH. 0.2 to 0.5 units/ml has been considered to be the desired level for prevention of VTE. Although this method was available since the 1970s, their cost was viewed to prohibit their broad use until recently.
Previous studies determined the safety and effectiveness of fixed dose prophylactic regiments via clinical outcomes. This strategy has several shortcomings.
The current study was there for devised to examine in vivo activity of LMWH in patients receiving a fixed dose prophylactic regimen, in order to assess the effectiveness of this method.
详细描述
The anti-factor Xa (anti-Xa) assay is a functional assay that facilitates the measurement of antithrombin (AT)-catalyzed inhibition of factor Xa by unfractionated heparin (UFH) and direct inhibition of factor Xa by low-molecular-weight heparin (LMWH). As a result, Anti-factor Xa level reflect the in situ pharmacological activity of LMWH. 0.2 to 0.5 units/ml has been considered to be the desired level for prevention of VTE. Although this method was available since the 1970s, their cost was viewed to prohibit their broad use until recently.
Previous studies determined the safety and effectiveness of fixed dose prophylactic regiments via clinical outcomes. This strategy has several shortcomings.
The current study was there for devised to examine in vivo activity of LMWH in patients receiving a fixed dose prophylactic regimen, in order to assess the effectiveness of this method.
Purpose To perform an exploratory prospective analysis of longitudinal data sets to assess anti-factor Xa levels in a cohort of patients recovering from acute ischemic stroke and receiving prophylactic-dose LMWH for VTE prevention.
Primary Outcome Measures:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Acute Ischemic stroke per imaging study
- •Clinical decision to administer VTE prophylaxis. (i.e.patients in whom a diagnosis of hemorrhagic stroke has been excluded, the risk of bleeding (hemorrhagic transformation of stroke or bleeding into another site) is assessed to be low, and who have one or more of the following: • major restriction of mobility • previous history of VTE • dehydration or comorbidities (such as malignant disease).Age: 55-80 years)
- •Exclusion criteria:
- •Obese (>150 KG)
- •Suffer from renal insufficiency (ccl<30)
排除标准
- 未提供
结局指标
主要结局
Anti-Xa level
时间窗: 3-4 hours post LMWH administration
Flowing at least 7 consecutive days of treatment blood sample will be drown 3-4 hours post LMWH administration and sent for The anti-factor Xa (anti-Xa) assay.
次要结局
未报告次要终点
研究者
Motti Ratmansky, MD
PI
Loewenstein Hospital