Use of Tinzaparin for Anticoagulation in Hemodialysis (HEMO-TIN)

Christine Ribic

Status and phase: Completed; Phase 4

Conditions: Kidney Failure, Chronic

Treatments: Drug: Placebo (for Tinzaparin); Drug: Placebo (for Unfractionated Heparin); Drug: Unfractionated Heparin; Drug: Tinzaparin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01930396

13-7822377

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

191 participants in 2 patient groups

Tinzaparin

Experimental group

Treatment:

Drug: Tinzaparin

Drug: Placebo (for Unfractionated Heparin)

Unfractionated Heparin

Active Comparator group

Treatment:

Drug: Unfractionated Heparin

Drug: Placebo (for Tinzaparin)