NCT00407641

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Longer than P75 for phase_4 diabetes-mellitus

Geographic Reach
1 country

13 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 22, 2017

Status Verified

January 1, 2017

Enrollment Period

5.8 years

First QC Date

December 4, 2006

Last Update Submit

December 21, 2017

Conditions

Diabetes MellitusHemodialysis

Keywords

diabetes mellituschronic hemodialysisanticoagulationoutcome

Outcome Measures

Primary Outcomes (1)

  • the composite event rate in death (any cause), myocardial infarction and stroke

Secondary Outcomes (2)

  • Cardio-vascular: the composite event rate of unstable angina, transient ischemic attacks, peripheral arterial disease, other, consequent to atherosclerosis

  • Lipid profile

Study Arms (2)

Tinzaparin

EXPERIMENTAL

Patients will receive Tinzaparin as anticoagulant during the HD session.

Drug: Tinzaparin administration

Heparin

ACTIVE COMPARATOR

Patients will receive Heparin as an anticoagulant during the HD session

Drug: Heparin administration

Interventions

Tinzaparin administrationDRUG

Patients will receive tinzaparin during the HD session

Tinzaparin
Heparin administrationDRUG

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

Heparin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • willingness to give written informed consent for participation in the study
  • age 18-80 years old
  • ability to understand and follow instructions and able to participate in the study for the entire period
  • clinically stable (based on the investigator's judgment) within the three months prior to the screening visit
  • written and signed agreement

You may not qualify if:

  • antecedents of cerebrovascular accident, documented myocardial infarction, coronary angioplasty or bypass surgery within 6 months prior to the screening visit
  • currently enrollment in any other investigational device or drug study, or participation in another clinical study within 30 days prior to the screening visit
  • known or suspected drug or alcohol abuse
  • known congenital or acquired bleeding disorders including hepatic failure and amyloidosis, present active major bleeding;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Baia Mare County Hospital

Baia Mare, Romania

Location

"Sarah" Hemodialysis Centre

Brasov, Romania

Location

"Dr Carol Davila" Teaching Hospital of Nephrology

Bucharest, 010731, Romania

Location

"N Paulescu" Institute

Bucharest, Romania

Location

Fundeni Clinical Hospital

Bucharest, Romania

Location

Cluj University Hospital

Cluj-Napoca, Romania

Location

Dolj County Hospital

Craiova, Romania

Location

Vrancea County Hospital

Focşani, Romania

Location

"CI Parhon" Clinical Hospital

Iași, Romania

Location

Bihor County Hospital

Oradea, Romania

Location

Prahova County Hospital

Ploieşti, Romania

Location

Dambovita County Hospital

Târgovişte, Romania

Location

Timisoara County Hospital

Timișoara, Romania

Location

Related Publications (1)

  • Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

    PMID: 38189593DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gabriel Mircescu, Professor

    Dr Carol Davila Teaching Hospital of Nephrology

    STUDY CHAIR

  • Constantin Verzan, MD, PhD

    "Dr Carol Davila" Teaching Hospital of Neprology

    STUDY DIRECTOR

  • Cristina Capusa, MD, PhD

    Dr Carol Davila Teaching Hospital of Nephrology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

March 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2017

Last Updated

December 22, 2017

Record last verified: 2017-01

Locations

RO(13)