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Effects of Tinzaparin on Cardio-vascular Outcomes and on Blood Lipids in Diabetic Patients on Chronic Hemodialysis

NCT00407641 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-12-22

No results posted yet for this study

Summary

Low molecular weight heparin (LMWH) provides a safe and effective alternative to UFH for hemodialysis anticoagulation. While unfractionated (UF) heparin has been implicated in hyper-lipidemia, the effect of LMWHs on the lipid profile in non-diabetic patients on chronic hemodialysis remains controversial. The effect of LMWH in diabetic patients, a high risk group for developing hyper-lipidemia and cardio-vascular disease, has not been studied.

The study intends to examine the long-term effects of the replacement of UFH by LMWH (tinzaparin sodium) on cardio-vascular outcomes and on lipoprotein profiles in a large group of diabetic patients stable on HD.

Conditions

Interventions

DRUG

Tinzaparin administration

Patients will receive tinzaparin during the HD session

DRUG

Heparin administration

Patients will receive Heparin as an anticoagulant during the HD session.

Sponsors & Collaborators

  • Anemia Working Group Romania

    lead OTHER

Principal Investigators

  • Gabriel Mircescu, Professor · Dr Carol Davila Teaching Hospital of Nephrology

  • Constantin Verzan, MD, PhD · "Dr Carol Davila" Teaching Hospital of Neprology

  • Cristina Capusa, MD, PhD · Dr Carol Davila Teaching Hospital of Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2015-01-31
Completion
2017-01-31

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00407641 on ClinicalTrials.gov