Use of Tinzaparin for Anticoagulation in Hemodialysis

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christine Ribic
• Collaborators: LEO Pharma; McMaster University
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

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