LMWH Infusion as Anticoagulation for Home HD

November 4, 2016 updated by: Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital

Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis

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.

Study Overview

Status

Unknown

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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Hong Kong, Hong Kong
        • Recruiting
        • Alice Ho Miu Ling Nethersole Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Other Names:
  • Fraxiparine
Active Comparator: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prothrombin time
Time Frame: Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
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
Time Frame: 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
Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis
Anti-Xa level
Time Frame: 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
Pre-dialysis; the 2nd, 4th, 6th and 8th hours of dialysis; 24 hours after administration of LMWH
Dialyser urea and creatinine clearances
Time Frame: 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
At 15 mins after starting hemodialysis and 15 mins before the end of hemodialysis
Dialyser thrombus score
Time Frame: At the end of hemodialysis (8th hour)
Dialyser thrombus score is evaluated in both of the LMWH and UFH arms
At the end of hemodialysis (8th hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Steve Siu-Man Wong, MBChB, FRCPC, Alice Ho Miu Ling Nethersole Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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