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A Comparative Study of Two Kinds of Hemodialysis Filters

A Randomized, Crossover, Controlled Clinical Study of the Capillary High-Flux Hemodialysis Filters OCI-HF160 and FX800HDF

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05899283
Enrollment
10
Registered
2023-06-12
Start date
2021-03-01
Completion date
2022-10-30
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremia

Keywords

Hemodialysis Filter, OCI-HF160, FX800HDF

Brief 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.

Interventions

DEVICEOCI-HF160

OCI-HF160 are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.

DEVICEFX800HDF

FX800HDF are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. 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.

Design outcomes

Primary

MeasureTime frameDescription
Filter coagulation grade 34 hoursFilter coagulation grade 3 is a severe clotting events
Filter multiplexer residual volume <0.84 hoursFilter multiplexer residual volume \<0.8 is also a severe clotting events

Secondary

MeasureTime frameDescription
Blood coagulation factor TF4 hoursTF is the initiating factor of coagulation reaction
Blood platelets4 hoursThe normal value of blood platelets is 100×10\^9/L\ 300×10\^9/L
Blood coagulation factor FXII4 hoursCoagulation factor FXII is a protease involved in the blood coagulation pathway
Hemoglobin4 hoursThe normal values are 120-160g/L for adult males and 110-150g/L for adult females
Scanning electron microscope4 hoursScanning electron microscopy to observe the area of the dialyzer fibrous clot as a percentage of the entire field of view
Single-cell transcriptome sequencing4 hoursWith the consent of the patients, blood were taken for analysis. Isolation of lymphocytes from blood to measure its gene expression profile
Transmembrane pressure4 hoursTransmodular pressure changes were recorded every 15 minutes during dialysis
Blood coagulation factor F1+24 hoursCoagulation factor F1+2 can reflect thrombin activity
Leukocytes4 hoursThe normal value is 4×10\^9/L\ 10×10\^9/L

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026