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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01930396
First Posted: August 28, 2013
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
McMaster University
LEO Pharma
Information provided by (Responsible Party):
Christine Ribic, St. Joseph's Healthcare Hamilton
  Purpose
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 Intervention Phase
Kidney Failure, Chronic Drug: Tinzaparin Drug: Unfractionated Heparin Drug: Placebo (for Tinzaparin) Drug: Placebo (for Unfractionated Heparin) Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Christine Ribic, St. Joseph's Healthcare Hamilton:

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

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

Enrollment: 191
Study Start Date: September 2013
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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
  Contacts and Locations
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


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

Responsible Party: Christine Ribic, Nephrologist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01930396     History of Changes
Other Study ID Numbers: 13-7822377
First Submitted: August 22, 2013
First Posted: August 28, 2013
Last Update Posted: October 14, 2016
Last Verified: October 2016

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

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