Use of Tinzaparin for Anticoagulation in Hemodialysis
HEMO-TIN
Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)
1 other identifier
interventional
191
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2013
CompletedFirst Posted
Study publicly available on registry
August 28, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 14, 2016
October 1, 2016
3 years
August 22, 2013
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of major, clinically important non-major or minor bleeding
26 weeks
Secondary Outcomes (1)
Clotting in extracorporeal dialysis circuit
During Hemodialysis (weekly for 26 weeks)
Study Arms (2)
Tinzaparin
EXPERIMENTALUnfractionated Heparin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christine Ribiclead
- McMaster Universitycollaborator
- LEO Pharmacollaborator
Study Sites (1)
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Related Publications (1)
Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
PMID: 38189593DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Christine M Ribic, MD, MSc
St. Joseph's Healthcare Hamilton/McMaster University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Nephrologist
Study Record Dates
First Submitted
August 22, 2013
First Posted
August 28, 2013
Study Start
September 1, 2013
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
October 14, 2016
Record last verified: 2016-10