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

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02607111
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 23.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure	Drug: Dalteparin	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A New Anticoagulation Method Using Dalteparin in Quotidian and Nocturnal Home Hemodialysis Patients: A Prospective Study
• Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The mean dalteparin dose for the daily home hemodialysis patients [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Sciences Centre	London	Ontario	Canada	N6A 5A5

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT02607111
• Other Study ID Numbers: 107283
• First Posted: Nov 17, 2015
• Last Update Posted: Feb 24, 2020
• Last Verified: Sep 1, 2016

• Keywords provided by Lawson Health Research Institute: Dalteparin; Dosage; Home Hemodialysis
• Additional relevant MeSH terms: Renal Insufficiency; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight

Study Results

No Results Posted as of Feb 24, 2020