LMWH Infusion as Anticoagulation for Home HD
- Registration Number
- NCT02957877
- Lead Sponsor
- Alice Ho Miu Ling Nethersole Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- Prevalent NHHD patients who have received >1 year dialysis with unfractionated heparin as anticoagulant
- Age >= 18
- Informed consent available
- History of intolerance to LMWHs during HD
- Receiving warfarin or other oral anticoagulant
- Pregnant patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description UFH arm Unfractionated heparin 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 LMWH arm Nadroparin 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
- Primary Outcome Measures
Name Time Method Prothrombin time 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 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 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 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 At the end of hemodialysis (8th hour) Dialyser thrombus score is evaluated in both of the LMWH and UFH arms
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alice Ho Miu Ling Nethersole Hospital
🇭🇰Hong Kong, Hong Kong