Endstage Renal Disease
Conditions
Keywords
Anticoagulation, Anti-Xa activity, Low-molecular weight heparin, Unfractionated heparin
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.
Interventions
DRUGNadroparin
A nadroparin infusion regimen (loading dose of 35 IU/kg, followed by 10 IU/kg per hour for 6 hours) is administered as anticoagulation during the 8-hour hemodialysis.
DRUGUnfractionated heparin
The individualized unfractionated heparin infusion regimen currently employed by the recruited patients in their home dialysis treatment is administered as anticoagulation during the 8-hour hemodialysis.
Sponsors
Alice Ho Miu Ling Nethersole Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prevalent NHHD patients who have received \>1 year dialysis with unfractionated heparin as anticoagulant * Age \>= 18 * Informed consent available
Exclusion criteria
* History of intolerance to LMWHs during HD * Receiving warfarin or other oral anticoagulant * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Hong Kong
Contacts
Primary ContactSteve Siu-Man Wong, MBChB, FRCPC
Outcome results
None listed