Use of Tinzaparin for Anticoagulation in Hemodialysis

Phase 4

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Drug: Tinzaparin; Drug: Unfractionated Heparin; Drug: Placebo (for Unfractionated Heparin); Drug: Placebo (for Tinzaparin)

• Registration Number: NCT01930396
• Lead Sponsor: Christine Ribic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-28
• Study Start: 2013-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tinzaparin	Tinzaparin	-
Tinzaparin	Placebo (for Unfractionated Heparin)	-
Unfractionated Heparin	Unfractionated Heparin	-
Unfractionated Heparin	Placebo (for Tinzaparin)	-

Primary Outcome Measures

Name	Time	Method
Rate of major, clinically important non-major or minor bleeding	26 weeks

Secondary Outcome Measures

Name	Time	Method
Clotting in extracorporeal dialysis circuit	During Hemodialysis (weekly for 26 weeks)

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada