Use of Tinzaparin for Anticoagulation in Hemodialysis

Overview

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.

Full Title of Study: “Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2016

Interventions

  • Drug: Tinzaparin
  • Drug: Unfractionated Heparin
  • Drug: Placebo (for Tinzaparin)
    • 0.9% Normal Saline
  • Drug: Placebo (for Unfractionated Heparin)
    • 0.9% Normal Saline

Arms, Groups and Cohorts

  • Experimental: Tinzaparin
  • Active Comparator: Unfractionated Heparin

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Christine Ribic
  • Collaborator
    • McMaster University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Christine Ribic, Nephrologist – St. Joseph’s Healthcare Hamilton
  • Overall Official(s)
    • Dr. Christine M Ribic, MD, MSc, Principal Investigator, St. Joseph’s Healthcare Hamilton/McMaster University

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