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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02607111
Other study ID # 107283
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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