A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients

February 20, 2020 updated by: Lawson Health Research Institute

A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients: A Prospective Study

This study evaluates the optimal dosage and safety of Dalteparin when used as an anticoagulant for hemodialysis therapies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Routine anticoagulation is required during hemodialysis treatments. In North America, the anticoagulant of choice for hemodialysis therapies is unfractionated heparin (UFH), whereas in Western Europe, it is low molecular weight heparin (LMWH). Dalteparin is more commonly used in Canada and has been approved for use in the in-centre thrice-weekly hemodialysis population at a fixed dose of 5000 units. However, there have been no published studies to assess the use of dalteparin in home quotidian and/or nocturnal hemodialysis therapies. Patients on frequent hemodialysis or nocturnal hemodialysis in the home will be converted to Dalteparin from Heparin for 4 weeks to evaluate the optimal dosage and to assess its safety in this population

Study Type

Interventional

Enrollment (Actual)

15

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 Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre

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:

  • Currently undergoing short-hour daily and nocturnal hemodialysis through the home dialysis program at London Health Sciences Centre.

Exclusion Criteria:

  • Patients with increased bleeding risks
  • Currently on full dose anticoagulants
  • Active bleeding
  • Diabetic retinopathy
  • Active cancer receiving treatment within the past 6 months

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: open label
Dalteparin injected as a bolus into the arterial port of the hemodialysis machine every dialysis session for four weeks
Drug: Dalteparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean dalteparin dose for the daily home hemodialysis patients
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Susan Huang, MD, London Health Sciences Centre

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

August 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107283

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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