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Completed

NCT Number: NCT01930396

Use of Tinzaparin for Anticoagulation in Hemodialysis

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.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

tinzaparin

Drug

Other names: Innohep

Unfractionated heparin

Drug

Other names: Heparin LEO

Placebo (for Tinzaparin)

Drug

0.9% Normal Saline

Placebo (for Unfractionated Heparin)

Drug

0.9% Normal Saline

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)

Sponsors and collaborators

Lead sponsor

Christine Ribic

Other

Collaborators

  • LEO Pharma
  • McMaster University

Registry information

Official study title

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

Acronym: HEMO-TIN

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2013
Registry last updated
Oct 14, 2016

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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