Use of Tinzaparin for Anticoagulation in Hemodialysis (HEMO-TIN)

October 12, 2016 updated by: Christine Ribic

Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)

The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >= 18 years
  • End stage renal disease maintained on outpatient hemodialysis for >= 3 months
  • Frequency of hemodialysis: 3 times per week
  • Anticoagulation with an unfractionated heparin protocol for at least 4 weeks
  • Patient or legal guardian able to provide written consent
  • Baseline INR <= 1.3
  • Baseline platelet count >= 80,000 x 10^9/L

Exclusion Criteria:

  • Therapeutic systemic anticoagulation
  • Clinically apparent bleeding in the last 2 months
  • High risk of bleeding
  • Planned major surgery in the next 4 months
  • Major surgery in the past 48 hours
  • Pregnant or lactating
  • Child bearing potential
  • Allergy/intolerance to heparin or history of heparin induced thrombocytopenia
  • Current participation in a related randomized drug trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tinzaparin
Drug: Tinzaparin
Other Names:
  • Innohep
Drug: Placebo (for Unfractionated Heparin)
0.9% Normal Saline
Active Comparator: Unfractionated Heparin
Drug: Unfractionated Heparin
Other Names:
  • Heparin LEO
Drug: Placebo (for Tinzaparin)
0.9% Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of major, clinically important non-major or minor bleeding
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Clotting in extracorporeal dialysis circuit
Time Frame: During Hemodialysis (weekly for 26 weeks)
During Hemodialysis (weekly for 26 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christine Ribic

Collaborators

McMaster University
LEO Pharma

Investigators

  • Principal Investigator: Dr. Christine M Ribic, MD, MSc, St. Joseph's Healthcare Hamilton/McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 28, 2013

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-7822377

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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