A Comparative Study of Two Kinds of Hemodialysis Filters
Condition: Uremia
MeSH terms: Uremia
Study type: Interventional

Summary: 
      This study exploring the expression characteristics of different cells of peripheral blood
      after exposure to two kinds of hemodialysis filter membrane materials will help to elucidate
      the key mechanisms of hemodialysis filter coagulation occurrence, which is an important
      guideline for reducing the occurrence of adverse events in hemodialysis.
    

Detailed description: 
      Background: Hemodialysis is one of the important alternative treatments for patients with
      uremia, and effective hemodialysis treatment can improve mortality and quality of life.
      However, during hemodialysis treatment, contact between blood and artificial materials often
      triggers a coagulation cascade reaction, which induces dialyzer coagulation. Studies have
      found that the incidence of dialyzer coagulation ranges from 5% to 14%. Once coagulation
      occurs, it inevitably affects the efficiency of the patient's dialysis and may lead to
      interruption of dialysis and blood loss, with the serious possibility of systemic
      thromboembolic events. To prevent clotting, systemic anticoagulation is usually required,
      which inevitably increases the risk of bleeding and lacks safe and effective anticoagulation
      methods. Some studies have suggested that the endogenous coagulation pathway is the primary
      pathway of dialyzer coagulation and that coagulation is effectively prevented by the use of
      antibodies to coagulation factor F Ⅻ during extracorporeal circulation. Some studies,
      however, suggest that the exogenous coagulation pathway is the primary pathway of dialyzer
      coagulation. An in-depth study of coagulation activation will help us to understand the true
      mechanism of dialyzer coagulation occurrence and provide new targets for the prevention and
      treatment of coagulation during dialysis.

      Methods: The study population consisted of 10 patients with uremia newly placed on
      hemodialysis treatment for the first time. Inclusion criteria: 1.70 years ≥age ≥ 18 years,
      gender not limited; 2.Patients with clinical diagnosis of chronic renal insufficiency (CKD
      stage 5) requiring renal replacement therapy; 3.Dialysis access was central venous catheter;
      4.Newly placed tubing, not dialysed patients; 5.Patients voluntarily participated and written
      informed consent signed by the patient or authorized delegate had been obtained.Exclusion
      criteria: 1.Patients with acute renal failure; 2.Patients are participating in other clinical
      studies; 3.Pregnancy or breastfeeding; 4.Use of hemostatic or anticoagulant drugs in the last
      1 week; 5.Positive infectious serum markers for HIV, syphilis, hepatitis B, and hepatitis C;
      6. Presence of active infection; 7.Allergy to dialyzers.Observation index: Peripheral blood
      before and after dialysis and filter after dialysis were collected, and blood routine,
      coagulation factors, single cell sequencing and electron microscopy were performed to compare
      the changes of coagulation factor activity before and after contact with dialysis membrane,
      and to screen the major coagulation factors and coagulation pathway activation pathways.
      Single-cell transcriptome characteristics of peripheral blood mononuclear cells before and
      after exposure to dialysis membranes were analyzed to explore the key mechanisms of
      peripheral blood cells regulating coagulation contact activation. Statistical methods: SPSS
      version 17.0 statistical software was applied for statistical analysis, and continuous
      variables were expressed as mean ± standard deviation, and non-continuous variables were
      expressed as percentages. Comparisons between two data were made by independent t-test or χ2
      test, and P<0.05 was statistically significant.
    

Intervention name(s): OCI-HF160; FX800HDF
Intervention type(s): Device; Device
Intervention description(s): OCI-HF160 are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.; FX800HDF are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.
Other intervention name(s): the Chengdu Ousai Hollow Fiber Membrane Hemodialysis Filter OCI-HF160; the Fresenius Hemodialysis Filter FX80
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemodialysis Filter; OCI-HF160; FX800HDF