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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01930396
Other study ID # 13-7822377
Secondary ID
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


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
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