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Completed

NCT Number: NCT02607111

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

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

Completed

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dalteparin

Drug

Primary outcomes

  1. The mean dalteparin dose for the daily home hemodialysis patients

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2015
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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