NCT02607111

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

February 24, 2020

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

November 16, 2015

Last Update Submit

February 20, 2020

Conditions

Kidney Failure

Keywords

DalteparinDosageHome Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • The mean dalteparin dose for the daily home hemodialysis patients

    4 weeks

Study Arms (1)

open label

EXPERIMENTAL

Dalteparin injected as a bolus into the arterial port of the hemodialysis machine every dialysis session for four weeks

Drug: Dalteparin

Interventions

DalteparinDRUG
open label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with increased bleeding risks
  • Currently on full dose anticoagulants
  • Active bleeding
  • Diabetic retinopathy
  • Active cancer receiving treatment within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Susan Huang, MD

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 17, 2015

Study Start

August 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 30, 2018

Last Updated

February 24, 2020

Record last verified: 2016-09

Locations

CA(1)