Renal failure
Conditions
Interventions
control group:Use heparin sodium to prevent blood clotting during extracorporeal blood circulation.
experimental group:Use mesometasone phosphate for injection to prevent blood clotting during extracorporeal blood circulation
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 years old to 75 years old, gender not restricted; 2. Body Mass Index (BMI) >= 18 kg/m^2; 3. Patients with end-stage renal failure due to hemodialysis, with maintenance hemodialysis treatment duration of >= 3 months, 2 to 3 dialysis sessions per week, with 80% of the dialysis treatment time in the past 3 months being 4 ± 0.5 hours, and the anticoagulation regimen before enrollment was heparin/low molecular weight heparin; 4. Have a mature arteriovenous fistula, with blood flow through the arteriovenous fistula > 200 mL/min; 5.Be able to follow the clinical trial protocol, and voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with a higher risk of severe bleeding disorders, such as active bleeding patients, patients with severe coagulation dysfunction (PT and/or APTT > 1.5×ULN, and/or INR > 2.0×ULN), patients with thrombocytopenia (platelet count 1.5×ULN), patients with unstable vital signs (those with sitting systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 60 mmHg); 3. Those who used antiplatelet drugs within 7 days before randomization, and/or used anticoagulant drugs (except for the necessary anticoagulant drugs for hemodialysis), and/or used immunosuppressants; 4. Those who had a history of severe trauma, major surgery, or severe infection within the previous month; 5. Those who had newly developed cerebral thrombosis, myocardial infarction, deep vein thrombosis, or other thromboembolic diseases within the past 3 months; 6. Patients with severe myocardial disease, refractory heart failure (such as NYHA cardiac function grade III or IV), severe hematological diseases, and a history of malignant tumors within 5 years (except for patients with stable cancer after treatment); 7. Patients with severe mental illness and who cannot cooperate; 8. Patients with allergic constitution, and those who are known to be allergic to the test drugs (mesnaform nemonistat, heparin sodium), their excipients, or low molecular weight heparin; 9. Those whose laboratory tests and electrocardiogram results, as judged by the researcher, are abnormal and have clinical significance and will affect the main efficacy assessment (such as severe arrhythmia); 10. Pregnant or lactating women, or those with positive blood/urine pregnancy test during the screening period, or those who have no effective contraceptive measures planned to be taken during the screening period (including the partner of the research participant), and/or those who have a fertility plan or sperm donation or egg donation plan during this period; 11. Those with any combined diseases that the researcher considers may interfere with the study assessment, or the researcher considers that participating in this study may pose greater risks to the patient; 12. Those who participated in other clinical trials within the previous month (except for the control group or placebo control group of other clinical trials); 13.Other situations that the researcher considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The situation of blood clotting within the dialyzer after hemodialysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| The types, incidence rates and severity levels of AE/SAE;Effective volume of the blood chamber in the dialyzer after dialysis;The changes in ACT before and after hemodialysis;Changes in the five coagulation indicators after hemodialysis compared to before the dialysis;Changes in circulatory blood pressure during hemodialysis;Laboratory tests, vital signs, physical examination, vascular access site examination and electrocardiogram;Time for stopping bleeding by applying pressure at the puncture site; | — |
Countries
China
Contacts
Public ContactYehong
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed