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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
Sponsor:
Collaborators:
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

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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
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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) ]


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

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
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Christine Ribic
McMaster University
LEO Pharma
Investigators
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Principal Investigator: Dr. Christine M Ribic, MD, MSc St. Joseph's Healthcare Hamilton/McMaster University
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Responsible Party: Christine Ribic, Nephrologist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01930396    
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:
Hemodialysis
Anticoagulation
Tinzaparin
Unfractionated Heparin
Randomized Controlled Trial
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Heparin
Calcium heparin
Tinzaparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action