Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection
研究概览
简要总结
Low-molecular weight heparins (LMWHs) as well as Unfractionated heparin (UFH) is used as anticoagulation during hemodialysis (HD) therapy. In this study the investigators have compared clinical efficacy and safety of LMWH and UFH, and their effect on lipid profile.
详细描述
In this prospective, randomized, cross-over study the investigators compared the safety, clinical efficacy of Clexane (enoxaparin sodium; Sanofi-Aventis) with unfractionated heparin in 27 chronic HD patients. Group A received Clexane (enoxaparin sodium; Sanofi-Aventis) and were followed up for 3 months and then crossed over to Unfractionated heparin for a further 3-month period. Group B received Unfractionated heparin first and then crossed over to Clexane, each followed up for 3 months. Heparin anticoagulation, clinical clotting and hemorrhage were evaluated by visual inspection after blood draining of the air trap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in end stage renal failure requiring maintenance dialysis were recruited into the study
排除标准
- •Patients with known bleeding disorders
- •Subjects receiving oral or other forms of anticoagulant therapy (e.g. warfarin, aspirin) or drugs that could affect heparin activity (e.g. digitalis, tetracyclines, and antihistamines) were also excluded. Subjects continued their usual medication (including lipid-lowering therapy ) and were treated in the normal manner by their caring physicians during the study.
研究组 & 干预措施
enoxaparin
enoxaparin sodium (Clexane) (40 mg) followed prospectively for 3 months (36 dialyses)
干预措施: low molecular weight heparin (enoxaparin sodium) (Drug)
standard unfractionated heparin
standard unfractionated heparin followed prospectively for 3 months (36 dialyses)
干预措施: standard unfractionated heparin (Drug)
结局指标
主要结局
Fibrin/clot formation in the dialyzer and Hemorrhage in Dialysis by visual inspection
时间窗: 3 month
The frequency and degree of clot and fibrin formation in both the dialyzer and lines were scored on a 10-point scale, with 1 indicating no clot formation and 10 sever clotting or total occlusion. This assessment was done after the blood had been returned to the patient by flushing the dialyzer and lines with normal saline. Hemorrhage or thrombosis, during and between dialyses was also noted. Heparin anticoagulation, Clinical clotting and Hemorrhage were evaluated by visual inspection. Hemorrhages were categorized as weak, moderate, and severe.
次要结局
- changes in serum Cholesterol,low and High Density Lipoprotein and Triglycerid.(3 month)