LMWH Infusion as Anticoagulation for Home HD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis

Conditions
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Endstage Renal Disease

Intervention / Treatment
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* Drug: Nadroparin
* Drug: Unfractionated heparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMWH arm<br>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 | Drug: Nadroparin<br>* 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.<br>* Other names: Fraxiparine;|
| Active Comparator: UFH arm<br>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 | Drug: Unfractionated heparin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anticoagulation, Anti-Xa activity, Low-molecular weight heparin, Unfractionated heparin