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

Launched by ANEMIA WORKING GROUP ROMANIA · Dec 4, 2006

Keywords

ClinConnect Summary

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 exceed 20% per year. After stratification for age, race and gender, cardio-vascular mortality is 10-20 times higher in these patients than in the general population. Thus cardio-vascular risk factors in these patients should be managed early, aggressively and in a multi-factorial manner in order to reduce their high cardio-vascular morbidity and mortality.

Low molecular weight heparin (LMWH) pro...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.