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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LMWH arm | Experimental | 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 |
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| UFH arm | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadroparin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prothrombin time | Prothrombin time is monitored in both of the LMWH and UFH arms | Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis |
| Activated partial thromboplastin time | Activated partial thromboplastin time is monitored in both of the LMWH and UFH arms | Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis |
| Anti-Xa level | Anti-Xa level is only monitored in the LMWH arm | Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH |
| Dialyser urea and creatinine clearances | Dialyser urea and creatinine clearances are evaluated in both of the LMWH and UFH arms | At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis |
| Dialyser thrombus score | Dialyser thrombus score is evaluated in both of the LMWH and UFH arms | At the end of hemodialysis (8th hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Siu-Man Wong, MBChB, FRCPC | Contact | (852) 26892000 | stevesmwong@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Steve Siu-Man Wong, MBChB, FRCPC | Alice Ho Miu Ling Nethersole Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alice Ho Miu Ling Nethersole Hospital | Recruiting | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38189593 | Derived | Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2. |
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| ID | Term |
|---|---|
| D017762 | Nadroparin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Unfractionated heparin | Drug | 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. |
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