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CompletedNCT01930396HEMO-TINUpdated Oct 14, 2016

Use of Tinzaparin for Anticoagulation in Hemodialysis

A Phase 4 interventional study of Tinzaparin and Unfractionated Heparin in Kidney Failure, Chronic, sponsored by Christine Ribic. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-14.

Sponsored by Christine Ribic · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
191
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Kidney Failure, Chronic

Keywords

  • Hemodialysis
  • Anticoagulation
  • Tinzaparin
  • Unfractionated Heparin
  • Randomized Controlled Trial
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 191 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

This is the only study on the registry with Christine Ribic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
191 participants (actual)

Study arms

  • Experimental
    Tinzaparin

    Drug: Tinzaparin · Drug: Placebo (for Unfractionated Heparin)

  • Active comparator
    Unfractionated Heparin

    Drug: Unfractionated Heparin · Drug: Placebo (for Tinzaparin)

Interventions

  • DrugTinzaparin

    Also known as: Innohep

  • DrugUnfractionated Heparin

    Also known as: Heparin LEO

  • DrugPlacebo (for Tinzaparin)

    0.9% Normal Saline

  • DrugPlacebo (for Unfractionated Heparin)

    0.9% Normal Saline

06

What researchers measure

Primary outcomes

  1. Rate of major, clinically important non-major or minor bleeding

    Time frame: 26 weeks

Secondary outcomes

  1. Clotting in extracorporeal dialysis circuit

    Time frame: During Hemodialysis (weekly for 26 weeks)

07

Study locations

1 site
  • St. Joseph's Healthcare Hamilton
    Hamilton, Ontario L8N 4A6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01930396
Lead sponsor
Christine Ribic
Collaborators
McMaster University, LEO Pharma
Responsible party
Christine Ribic (Nephrologist, St. Joseph's Healthcare Hamilton) — Sponsor-investigator
First posted
Aug 28, 2013
Start date
Sep 2013
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Oct 14, 2016

Study contacts

Dr. Christine M Ribic, MD, MSc
principal investigator · St. Joseph's Healthcare Hamilton/McMaster University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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