Use of Tinzaparin for Anticoagulation in Hemodialysis

Kidney Failure, Chronic Clinical Trial

— HEMO-TIN  

Official title:

Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930396
• Other study ID #: 13-7822377
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2013
• Last updated: October 12, 2016
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Tinzaparin

• Unfractionated Heparin

• Placebo (for Tinzaparin)
0.9% Normal Saline
• Placebo (for Unfractionated Heparin)
0.9% Normal Saline

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Christine Ribic	LEO Pharma, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major, clinically important non-major or minor bleeding		26 weeks	Yes
Secondary	Clotting in extracorporeal dialysis circuit		During Hemodialysis (weekly for 26 weeks)	Yes