Trial record 9 of 191 for:    Open Studies | "Heparin"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by St. Joseph's Healthcare Hamilton
Sponsor:
Collaborators:
McMaster University
LEO Pharma
Information provided by (Responsible Party):
Christine Ribic, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01930396
First received: August 22, 2013
Last updated: August 27, 2013
Last verified: August 2013
  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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01930396

Contacts
Contact: Dr. Christine M Ribic, MD, MSc 905-522-1155 ext 33261 christine.ribic@medportal.ca
Contact: Trevor J Wilkieson, MSc 905-522-1155 ext 35164 twilkies@stjoes.ca

Locations
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
Investigators
Principal Investigator: Dr. Christine M Ribic, MD, MSc St. Joseph's Healthcare Hamilton/McMaster University
  More Information

No publications provided

Responsible Party: Christine Ribic, Nephrologist, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov 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:
Hemodialysis
Anticoagulation
Tinzaparin
Unfractionated Heparin
Randomized Controlled Trial

Additional relevant MeSH terms:
Calcium heparin
Heparin
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Tinzaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014