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

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ClinicalTrials.gov Identifier: NCT01930396
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : October 14, 2016
McMaster University
LEO Pharma
Information provided by (Responsible Party):
Christine Ribic, St. Joseph's Healthcare Hamilton

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Tinzaparin Drug: Unfractionated Heparin Drug: Placebo (for Tinzaparin) Drug: Placebo (for Unfractionated Heparin) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)
Study Start Date : September 2013
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tinzaparin Drug: Tinzaparin
Other Name: Innohep
Drug: Placebo (for Unfractionated Heparin)
0.9% Normal Saline
Active Comparator: Unfractionated Heparin Drug: Unfractionated Heparin
Other Name: Heparin LEO
Drug: Placebo (for Tinzaparin)
0.9% Normal Saline

Primary Outcome Measures :
  1. Rate of major, clinically important non-major or minor bleeding [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Clotting in extracorporeal dialysis circuit [ Time Frame: During Hemodialysis (weekly for 26 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930396

Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Christine Ribic
McMaster University
LEO Pharma
Principal Investigator: Dr. Christine M Ribic, MD, MSc St. Joseph's Healthcare Hamilton/McMaster University

Responsible Party: Christine Ribic, Nephrologist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01930396     History of Changes
Other Study ID Numbers: 13-7822377
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

Keywords provided by Christine Ribic, St. Joseph's Healthcare Hamilton:
Unfractionated Heparin
Randomized Controlled Trial

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action