Low Molecular Weight Heparin in Prevention of Recurrent Arteriovenous Graft Thrombosis in Chronic Hemodialysis Patients.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- To compare the time of onset of a new thrombotic event after successful angiography of the AV graft.
研究概览
简要总结
The aim of the study is to evaluate the effect of Enoxaparin (LMWH) on the incidence of AV graft thromboses in patients on chronic hemodialysis.
Primary efficacy end point of the study: to compare the time of onset of a new thrombotic event after successful angiography of the AV graft.
Pprimary safety outcome of the study: frequency of hemorrhage. Design and methods: Following a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on chronic hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body weight per day or control group (not on Clexane). Patients will be followed for a year or till next AV graft thrombotic occlusion, if it occurs before. In both groups we will compare time periods in months between first and recurrent thrombotic events of AVG by evaluation the difference between two sample means. Also interim analysis of AV grafts patency between the two groups will be evaluated at different time points: three, six and twelve months after randomization. Patients in both groups will receive unfractionated heparin during dialysis session to prevent thrombosis of extracorporeal circulation. Patients from Enoxaparin group will receive a half dose (500 units/hour) to prevent possible risk of bleeding during the session. Before randomization all patients will be evaluated for hypercoagulability state which will include: Factor V Laden deficiency, Anti phospholipid antibodies (APLA), Antithrombin III deficiency and Protein C/S deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •hemodialysis patients ≥ 18 years of age after occurrence of AVG thrombosis and successful thrombolysis/thrombectomy with angioplasty.
排除标准
- •Known allergy to enoxaparin
- •Persistent systolic blood pressure 180 or more and/or persistent diastolic blood pressure 100 or more
- •Chronic Warfarin treatment
- •Double antiagregant treatment (aspirin plus clopidogrel)
- •Platelets count below 80000/µl
- •Known HIT (Heparin Induced Thrombocytopenia)
- •Recent bleeding (<2 weeks)
- •Recent stroke (<4 weeks)
- •Reduced mental status and inability to give informed consent
研究组 & 干预措施
Enoxaparin
Following a first AV graft thrombosis and successful thrombolysis with angioplasty, patients on chronic hemodialysis will be randomized to s.c Enoxaparin (Clexane) 0.5 mg/1kg of body weight per day or control group (not on Clexane).
干预措施: Enoxaparin (Drug)
结局指标
主要结局
To compare the time of onset of a new thrombotic event after successful angiography of the AV graft.
时间窗: 1 y
次要结局
未报告次要终点
研究者
Dr. Sidney Ben Chetrit
MD
Meir Hospital, Kfar Saba, Israel
