Status:
WITHDRAWN
Effects of Tinzaparin on Cardio-vascular Outcomes and on Blood Lipids in Diabetic Patients on Chronic Hemodialysis
Lead Sponsor:
Anemia Working Group Romania
Conditions:
Diabetes Mellitus
Hemodialysis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 eff...
Detailed Description
Hemodialysed diabetic patients constitute a high-risk subset of patients for developing cardio-vascular disease, which accounts for nearly 50% of deaths. In those patients, mortality rates probably ex...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
- increased risk of hemorrhage, due to: pericarditis or bacterial endocarditis, severe uncontrolled hypertension, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, shortly after brain, spinal or ophthalmological surgery, concomitant treatment with platelet inhibitors, recent surgical procedures (especially with hemorrhagic complications or those in which hemorrhagic complications would be very severe - cardio-vascular, ophthalmological or neurological), planned surgical procedure within the next week, (history of) heparin-induced thrombocytopenia, with any other disease which, in the opinion of the investigator, makes unacceptable his/her inclusion in the study (known hypersensitivity to heparin, benzyl alcohol, or pork products that should not be treated with innohep®, severe psychiatric disorders, age \<18 years, malignant disorders and a life expectancy \<6 months, patients that were involved in another research study (studies) in the last month.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00407641
Start Date
March 1 2009
End Date
January 1 2017
Last Update
December 22 2017
Active Locations (13)
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1
Baia Mare County Hospital
Baia Mare, Romania
2
"Sarah" Hemodialysis Centre
Brasov, Romania
3
"Dr Carol Davila" Teaching Hospital of Nephrology
Bucharest, Romania, 010731
4
"N Paulescu" Institute
Bucharest, Romania