Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Prothrombin time
研究概览
简要总结
There is a lack of data in the literature about the use of low-molecular weight heparin (LMWH) as anticoagulation for nocturnal home hemodialysis (NHHD). This study aims to evaluate the efficacy and safety of LMWH, administered by infusion method, as compared to unfractionated heparin as anticoagulation for NHHD treatment.
详细描述
Low-molecular weight heparin (LMWH) and unfractionated heparin (UFH) are established systemic anticoagulants for the patients who receive conventional thrice-weekly hemodialysis in absence of significant bleeding risk. For the patients who undergo nocturnal home hemodialysis (NHHD), LMWH is seldom utilized because of the need of an additional bolus injection during a long dialysis treatment, which is impractical as the patients are sleeping during hemodialysis. Moreover, there is a potential risk of LMWH accumulation due to its longer half-life. As there is a paucity of data in the literature on the use of LMWH for NHHD treatment, this trial is conducted to assess the safety and efficacy of LMWH, administered by infusion method, in this particular group of dialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Prevalent NHHD patients who have received >1 year dialysis with unfractionated heparin as anticoagulant
- •Age >= 18
- •Informed consent available
排除标准
- •History of intolerance to LMWHs during HD
- •Receiving warfarin or other oral anticoagulant
- •Pregnant patients
研究组 & 干预措施
LMWH arm
8-hour hemodialysis is performed on alternate day for a week at the dialysis unit (i.e. 3 sessions) by using low-molecular weight heparin (nadroparin) as anticoagulation
干预措施: Nadroparin (Drug)
UFH arm
8-hour hemodialysis is performed on alternate day for a week at the dialysis unit (i.e. 3 sessions) by using unfractionated heparin as anticoagulation
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
Prothrombin time
时间窗: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
Prothrombin time is monitored in both of the LMWH and UFH arms
Anti-Xa level
时间窗: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH
Anti-Xa level is only monitored in the LMWH arm
Activated partial thromboplastin time
时间窗: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
Activated partial thromboplastin time is monitored in both of the LMWH and UFH arms
Dialyser urea and creatinine clearances
时间窗: At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis
Dialyser urea and creatinine clearances are evaluated in both of the LMWH and UFH arms
Dialyser thrombus score
时间窗: At the end of hemodialysis (8th hour)
Dialyser thrombus score is evaluated in both of the LMWH and UFH arms
次要结局
未报告次要终点
研究者
Steve Siu-Man Wong
Associate Consultant
Alice Ho Miu Ling Nethersole Hospital