simple hemodialysis access stenosis in adults
Conditions
Interventions
experimental group A:Sulodexide soft capsule, oral preparation, 250LSU each time, 2 times a day (morning and evening), continuous medication for a total of 24 weeks.
experimental group B:Sulodexide soft capsule, oral preparation, 500LSU each time, 2 times a day (morning and evening), continuous medication for a total of 24 weeks.
experimental group C:None
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = age = 75 years old, male or female; 2. Use autologous arteriovenous fistula or artificial vascular fistula as long-term hemodialysis, regular hemodialysis 3 times a week; 3. For patients with mature autologous arteriovenous fistula or artificial vascular fistula after successful simple stenosis PTA (balloon dilation), the length of the diseased blood vessels of the patients before enrollment is between 2-6cm (single lesions or series lesions can be ); 4. The expected survival period is more than 1 year; 5. Those who have no reproductive plan during the research period (from the start of signing the informed consent form to 28 days after the last dose) and agree to take effective non-drug contraceptive measures during the research period; 6. Voluntarily sign the informed consent form before the start of activities related to this research, be able to understand the procedures and methods of this research, and be willing to strictly follow the clinical research protocol to complete this research.
Exclusion criteria
Exclusion criteria: 1. Patients with irregular hemodialysis or poor compliance; 2. Women who are preparing for pregnancy or during pregnancy or lactation; 3. Existing malignant tumor patients, such as prostate cancer, breast cancer, renal cell cancer or any other malignant tumor history or diagnosis (excluding cancer confirmed to be cured or in remission for = 5 years, basal cell or squamous cell skin cancer, cervical carcinoma in situ, or colon polyps removed by surgery); 4. The hemodialysis pathway of the patient has central vein disease, infection, tumor like expansion, pseudoaneurysm, high flow heart failure, distal limb ischemia related to the hemodialysis pathway, or other complications that require open surgical intervention; 5. There has been a major bleeding event that endangers life or leads to hospitalization or blood transfusion in the past year, and a gastrointestinal bleeding event in the past month; 6. Have vasculitis at the same time; 7. Patients with serious diseases judged by doctors include but are not limited to: 1) Known and untreated retinal vein occlusion or known and untreated proliferative diabetes retinopathy (risk of retinal thrombosis); 2) Hypertension patients diagnosed as poorly controlled before the start of the study, such as those who still maintain systolic blood pressure = 160mmHg or diastolic blood pressure = 95mmHg after combined use of three or more antihypertensive drugs, and cannot control blood pressure after dialysis; 3) Patients with high risk of bleeding such as active peptic ulcer and cirrhosis; 4) It is confirmed as an autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis or psoriatic arthritis; 5) Known hemosiderosis, hemochromatosis or hypercoagulable state; 6) Existing adverse condition of any active blood loss; 7) At the time of enrollment, the patient presented with congestive heart failure of New York Heart Association cardiac function grade III or IV; 8) Acute coronary syndrome, stroke, seizure or thrombosis/thromboembolism events (such as deep vein thrombosis or pulmonary embolism) occurred within 12 weeks before the start of study treatment; 9) Active or significant infection; 10) History of serious blood, liver, neuropathy, psychosis or other diseases; 11) Infectious diseases, such as HIV merger, were found at the time of enrollment; 8. Any organ transplantation has been carried out in the past or the date of organ transplantation has been scheduled; 9. The patient is known to be allergic to the active substance (sulodert) or any excipient of the product; 10. Known or suspected alcohol and/or drug abuse, alcoholism means drinking more than 2 units of alcohol per day (1 unit=360 mL beer or 45 mL Baijiu or 150 mL wine with 40% alcohol); 11. During the treatment period of the study, other systemic anticoagulants (such as warfarin, rivalsaban, etc.) other than the study drug should not be stopped, except the anticoagulants used on the day of dialysis; 12. Screening visit (visit 1), ALT or AST>2 times the upper limit of normal value (ULN); 13. Participated in other clinical studies within 1 month before the screening visit (visit 1) (defined as signing the informed consent form); 14. Patients receiving drug coated balloon therapy were excluded; 15. Other reasons that the researcher considers it inappropriate to participate in this study; 16. Patients who did not undergo PTA for the first time were less than 3 months from the latest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of bleeding events (24 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| Restenosis intervention rate and number of interventions for autologous arteriovenous fistula or artificial vascular fistula (24 weeks);The time and degree of restenosis of autologous arteriovenous fistula or artificial vascular fistula (24 weeks);Incidence of thrombosis in autologous arteriovenous fistula or artificial vascular fistula (24 weeks);Incidence of major bleeding events (24 weeks); | — |
Countries
China
Contacts
Public ContactQining Fu
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed