LMWH Infusion as Anticoagulation for Home HD

Alice Ho Miu Ling Nethersole Hospital

Status and phase: Unknown; Phase 4

Conditions: Endstage Renal Disease

Treatments: Drug: Unfractionated heparin; Drug: Nadroparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02957877

2015.415

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

LMWH arm

Experimental group

Description:

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

Treatment:

Drug: Nadroparin

UFH arm

Active Comparator group

Description:

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

Treatment:

Drug: Unfractionated heparin