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

Phase 4

Completed

• Conditions: Kidney Failure
• Interventions: Drug: Dalteparin

• Registration Number: NCT02607111
• Lead Sponsor: Lawson Health Research Institute

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-17
• Study Start: 2016-08
• Status Verified: 2016-09
• Primary Completion: 2018-07
• Study Completion: 2018-07-30
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label	Dalteparin	Dalteparin injected as a bolus into the arterial port of the hemodialysis machine every dialysis session for four weeks

Primary Outcome Measures

Name	Time	Method
The mean dalteparin dose for the daily home hemodialysis patients	4 weeks

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada