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LMWH Infusion as Anticoagulation for Home HD

NCT ID: NCT02957877

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-05-31

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.

Conditions

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Endstage Renal Disease

Keywords

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Anticoagulation Anti-Xa activity Low-molecular weight heparin Unfractionated heparin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LMWH arm

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

Group Type EXPERIMENTAL

Nadroparin

Intervention Type 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.

UFH arm

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

Group Type ACTIVE_COMPARATOR

Unfractionated heparin

Intervention Type 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.

Interventions

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Nadroparin

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.

Intervention Type DRUG

Unfractionated 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.

Intervention Type DRUG

Other Intervention Names

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Fraxiparine

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alice Ho Miu Ling Nethersole Hospital

OTHER

Sponsor Role lead

Responsible Party

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Steve Siu-Man Wong

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steve Siu-Man Wong, MBChB, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Alice Ho Miu Ling Nethersole Hospital

Locations

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Alice Ho Miu Ling Nethersole Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Steve Siu-Man Wong, MBChB, FRCPC

Role: CONTACT

Phone: (852) 26892000

Email: [email protected]

Facility Contacts

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Steve Siu-Man Wong, MBChB, FRCPC

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38189593 (View on PubMed)

Other Identifiers

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2015.415

Identifier Type: -

Identifier Source: org_study_id