Back to resultsA New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients
Primary Purpose
Kidney Failure
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dalteparin
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Failure focused on measuring Dalteparin, Dosage, Home Hemodialysis
Eligibility Criteria
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
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
open label
Arm Description
Dalteparin injected as a bolus into the arterial port of the hemodialysis machine every dialysis session for four weeks
Outcomes
Primary Outcome Measures
The mean dalteparin dose for the daily home hemodialysis patients
Secondary Outcome Measures
Full Information
NCT ID
NCT02607111
First Posted
November 16, 2015
Last Updated
February 20, 2020
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02607111
Brief Title
A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients
Official Title
A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the optimal dosage and safety of Dalteparin when used as an anticoagulant for hemodialysis therapies.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
Dalteparin, Dosage, Home Hemodialysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open label
Arm Type
Experimental
Arm Description
Dalteparin injected as a bolus into the arterial port of the hemodialysis machine every dialysis session for four weeks
Intervention Type
Drug
Intervention Name(s)
Dalteparin
Primary Outcome Measure Information:
Title
The mean dalteparin dose for the daily home hemodialysis patients
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Huang, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients
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