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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by St. Joseph's Healthcare Hamilton.
Recruitment status was  Not yet recruiting
McMaster University
LEO Pharma
Information provided by (Responsible Party):
Christine Ribic, St. Joseph's Healthcare Hamilton Identifier:
First received: August 22, 2013
Last updated: August 27, 2013
Last verified: August 2013
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 St. Joseph's Healthcare Hamilton:

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

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

Estimated Enrollment: 180
Study Start Date: September 2013
Estimated Primary Completion Date: September 2015 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01930396

Contact: Dr. Christine M Ribic, MD, MSc 905-522-1155 ext 33261
Contact: Trevor J Wilkieson, MSc 905-522-1155 ext 35164

Canada, Ontario
St. Joseph's Healthcare Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Dr. Christine M Ribic, MD, MSc         
Sub-Investigator: Dr. Mark A Crowther, MD, MSc         
Sub-Investigator: Dr. Azim S Gangji, MD, MSc         
Sub-Investigator: Dr. Deborah J Cook, MD, MSc         
Sub-Investigator: Dr. Michael Walsh, MD, PhD, MSc         
Sponsors and Collaborators
Christine Ribic
McMaster University
LEO Pharma
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 Identifier: NCT01930396     History of Changes
Other Study ID Numbers: 13-7822377 
Study First Received: August 22, 2013
Last Updated: August 27, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Calcium heparin
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 27, 2016