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

Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607111
• Other study ID #: 107283
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: July 30, 2018

Study information

• Verified date: September 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 30, 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Dalteparin

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean dalteparin dose for the daily home hemodialysis patients		4 weeks