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

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Tinzaparin
Unfractionated Heparin
Placebo (for Tinzaparin)
Placebo (for Unfractionated Heparin)
Sponsored by
Christine Ribic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring Hemodialysis, Anticoagulation, Tinzaparin, Unfractionated Heparin, Randomized Controlled Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tinzaparin

Unfractionated Heparin

Arm Description

Outcomes

Primary Outcome Measures

Rate of major, clinically important non-major or minor bleeding

Secondary Outcome Measures

Clotting in extracorporeal dialysis circuit

Full Information

First Posted
August 22, 2013
Last Updated
October 12, 2016
Sponsor
Christine Ribic
Collaborators
McMaster University, LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01930396
Brief Title
Use of Tinzaparin for Anticoagulation in Hemodialysis
Acronym
HEMO-TIN
Official Title
Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christine Ribic
Collaborators
McMaster University, LEO Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Hemodialysis, Anticoagulation, Tinzaparin, Unfractionated Heparin, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tinzaparin
Arm Type
Experimental
Arm Title
Unfractionated Heparin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tinzaparin
Other Intervention Name(s)
Innohep
Intervention Type
Drug
Intervention Name(s)
Unfractionated Heparin
Other Intervention Name(s)
Heparin LEO
Intervention Type
Drug
Intervention Name(s)
Placebo (for Tinzaparin)
Intervention Description
0.9% Normal Saline
Intervention Type
Drug
Intervention Name(s)
Placebo (for Unfractionated Heparin)
Intervention Description
0.9% Normal Saline
Primary Outcome Measure Information:
Title
Rate of major, clinically important non-major or minor bleeding
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Clotting in extracorporeal dialysis circuit
Time Frame
During Hemodialysis (weekly for 26 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Christine M Ribic, MD, MSc
Organizational Affiliation
St. Joseph's Healthcare Hamilton/McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Use of Tinzaparin for Anticoagulation in Hemodialysis

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