Use of Tinzaparin for Anticoagulation in Hemodialysis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01930396

Acronym

HEMO-TIN

Enrollment

191

Registered

2013-08-28

Start date

2013-09-30

Completion date

2016-09-30

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

Hemodialysis, Anticoagulation, Tinzaparin, Unfractionated Heparin, Randomized Controlled Trial

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.

Interventions

DRUGTinzaparin

DRUGUnfractionated Heparin

DRUGPlacebo (for Tinzaparin)

0.9% Normal Saline

DRUGPlacebo (for Unfractionated Heparin)

0.9% Normal Saline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of major, clinically important non-major or minor bleeding	26 weeks

Secondary

Measure	Time frame
Clotting in extracorporeal dialysis circuit	During Hemodialysis (weekly for 26 weeks)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026