NCT01930396CompletedPhase 4
Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Christine Ribic
- Enrollment
- 191
- Locations
- 1
- Primary Endpoint
- Rate of major, clinically important non-major or minor bleeding
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- 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
Arms & Interventions
Unfractionated Heparin
Active Comparator
Intervention: Placebo (for Tinzaparin) (Drug)
Tinzaparin
Experimental
Intervention: Tinzaparin (Drug)
Tinzaparin
Experimental
Intervention: Placebo (for Unfractionated Heparin) (Drug)
Unfractionated Heparin
Active Comparator
Intervention: Unfractionated Heparin (Drug)
Outcomes
Primary Outcomes
Rate of major, clinically important non-major or minor bleeding
Time Frame: 26 weeks
Secondary Outcomes
- Clotting in extracorporeal dialysis circuit(During Hemodialysis (weekly for 26 weeks))
Investigators
Christine Ribic
Nephrologist
St. Joseph's Healthcare Hamilton
Study Sites (1)
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