A Comparative Study of Two Kinds of Hemodialysis Filters

Uremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05899283
• Other study ID #: S2021-171-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: June 2023
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 30, 2022
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Uremia

Intervention

Device:
• OCI-HF160
OCI-HF160 are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.
• FX800HDF
FX800HDF are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Filter coagulation grade 3	Filter coagulation grade 3 is a severe clotting events	4 hours
Primary	Filter multiplexer residual volume <0.8	Filter multiplexer residual volume <0.8 is also a severe clotting events	4 hours
Secondary	Blood platelets	The normal value of blood platelets is 100×10^9/L~300×10^9/L	4 hours
Secondary	Hemoglobin	The normal values are 120-160g/L for adult males and 110-150g/L for adult females	4 hours
Secondary	Leukocytes	The normal value is 4×10^9/L~10×10^9/L	4 hours
Secondary	Blood coagulation factor TF	TF is the initiating factor of coagulation reaction	4 hours
Secondary	Blood coagulation factor FXII	Coagulation factor FXII is a protease involved in the blood coagulation pathway	4 hours
Secondary	Blood coagulation factor F1+2	Coagulation factor F1+2 can reflect thrombin activity	4 hours
Secondary	Scanning electron microscope	Scanning electron microscopy to observe the area of the dialyzer fibrous clot as a percentage of the entire field of view	4 hours
Secondary	Single-cell transcriptome sequencing	With the consent of the patients, blood were taken for analysis. Isolation of lymphocytes from blood to measure its gene expression profile	4 hours
Secondary	Transmembrane pressure	Transmodular pressure changes were recorded every 15 minutes during dialysis	4 hours