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

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.

Study Overview

• Status: Completed
• Conditions: Uremia
• Intervention / Treatment: Device: OCI-HF160; Device: FX800HDF

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A(OCI-HF160+FX800HDF); Group A first used the hemodialysis filter OCI-HF160, then used FX800HDF.	Device: OCI-HF160; OCI-HF160 are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.; Other Names: the Chengdu Ousai Hollow Fiber Membrane Hemodialysis Filter OCI-HF160; Device: FX800HDF; FX800HDF are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.; Other Names: the Fresenius Hemodialysis Filter FX80
Experimental: Group B(FX800HDF+OCI-HF160); Group B first used the hemodialysis filter FX800HDF, and then used OCI-HF160.	Device: OCI-HF160; OCI-HF160 are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.; Other Names: the Chengdu Ousai Hollow Fiber Membrane Hemodialysis Filter OCI-HF160; Device: FX800HDF; FX800HDF are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.; Other Names: the Fresenius Hemodialysis Filter FX80

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Filter coagulation grade 3	Filter coagulation grade 3 is a severe clotting events	4 hours
Filter multiplexer residual volume <0.8	Filter multiplexer residual volume <0.8 is also a severe clotting events	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood platelets	The normal value of blood platelets is 100×10^9/L~300×10^9/L	4 hours
Hemoglobin	The normal values are 120-160g/L for adult males and 110-150g/L for adult females	4 hours
Leukocytes	The normal value is 4×10^9/L~10×10^9/L	4 hours
Blood coagulation factor TF	TF is the initiating factor of coagulation reaction	4 hours
Blood coagulation factor FXII	Coagulation factor FXII is a protease involved in the blood coagulation pathway	4 hours
Blood coagulation factor F1+2	Coagulation factor F1+2 can reflect thrombin activity	4 hours
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
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
Transmembrane pressure	Transmodular pressure changes were recorded every 15 minutes during dialysis	4 hours

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hemodialysis Filter; OCI-HF160; FX800HDF
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Uremia
• Other Study ID Numbers: S2021-171-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No