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A Comparative Study of Two Kinds of Hemodialysis Filters

Primary Purpose

Uremia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
OCI-HF160
FX800HDF
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremia focused on measuring Hemodialysis Filter, OCI-HF160, FX800HDF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years, gender not limited; Patients with clinical diagnosis of chronic renal insufficiency (CKD stage 5) requiring renal replacement therapy; Dialysis access was central venous catheter; 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: Patients with acute renal failure; Patients are participating in other clinical studies; Pregnancy or breastfeeding; Use of hemostatic or anticoagulant drugs in the last 1 week; Positive infectious serum markers for HIV, syphilis, hepatitis B, and hepatitis C; Presence of active infection; Allergy to dialyzers.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A(OCI-HF160+FX800HDF)

Group B(FX800HDF+OCI-HF160)

Arm Description

Group A first used the hemodialysis filter OCI-HF160, then used FX800HDF.

Group B first used the hemodialysis filter FX800HDF, and then used OCI-HF160.

Outcomes

Primary Outcome Measures

Filter coagulation grade 3
Filter coagulation grade 3 is a severe clotting events
Filter multiplexer residual volume <0.8
Filter multiplexer residual volume <0.8 is also a severe clotting events

Secondary Outcome Measures

Blood platelets
The normal value of blood platelets is 100×10^9/L~300×10^9/L
Hemoglobin
The normal values are 120-160g/L for adult males and 110-150g/L for adult females
Leukocytes
The normal value is 4×10^9/L~10×10^9/L
Blood coagulation factor TF
TF is the initiating factor of coagulation reaction
Blood coagulation factor FXII
Coagulation factor FXII is a protease involved in the blood coagulation pathway
Blood coagulation factor F1+2
Coagulation factor F1+2 can reflect thrombin activity
Scanning electron microscope
Scanning electron microscopy to observe the area of the dialyzer fibrous clot as a percentage of the entire field of view
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
Transmembrane pressure
Transmodular pressure changes were recorded every 15 minutes during dialysis

Full Information

First Posted
January 31, 2023
Last Updated
June 1, 2023
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05899283
Brief Title
A Comparative Study of Two Kinds of Hemodialysis Filters
Official Title
A Randomized, Crossover, Controlled Clinical Study of the Capillary High-Flux Hemodialysis Filters OCI-HF160 and FX800HDF
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia
Keywords
Hemodialysis Filter, OCI-HF160, FX800HDF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A(OCI-HF160+FX800HDF)
Arm Type
Experimental
Arm Description
Group A first used the hemodialysis filter OCI-HF160, then used FX800HDF.
Arm Title
Group B(FX800HDF+OCI-HF160)
Arm Type
Experimental
Arm Description
Group B first used the hemodialysis filter FX800HDF, and then used OCI-HF160.
Intervention Type
Device
Intervention Name(s)
OCI-HF160
Other Intervention Name(s)
the Chengdu Ousai Hollow Fiber Membrane Hemodialysis Filter OCI-HF160
Intervention Description
OCI-HF160 are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.
Intervention Type
Device
Intervention Name(s)
FX800HDF
Other Intervention Name(s)
the Fresenius Hemodialysis Filter FX80
Intervention Description
FX800HDF are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood.
Primary Outcome Measure Information:
Title
Filter coagulation grade 3
Description
Filter coagulation grade 3 is a severe clotting events
Time Frame
4 hours
Title
Filter multiplexer residual volume <0.8
Description
Filter multiplexer residual volume <0.8 is also a severe clotting events
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Blood platelets
Description
The normal value of blood platelets is 100×10^9/L~300×10^9/L
Time Frame
4 hours
Title
Hemoglobin
Description
The normal values are 120-160g/L for adult males and 110-150g/L for adult females
Time Frame
4 hours
Title
Leukocytes
Description
The normal value is 4×10^9/L~10×10^9/L
Time Frame
4 hours
Title
Blood coagulation factor TF
Description
TF is the initiating factor of coagulation reaction
Time Frame
4 hours
Title
Blood coagulation factor FXII
Description
Coagulation factor FXII is a protease involved in the blood coagulation pathway
Time Frame
4 hours
Title
Blood coagulation factor F1+2
Description
Coagulation factor F1+2 can reflect thrombin activity
Time Frame
4 hours
Title
Scanning electron microscope
Description
Scanning electron microscopy to observe the area of the dialyzer fibrous clot as a percentage of the entire field of view
Time Frame
4 hours
Title
Single-cell transcriptome sequencing
Description
With the consent of the patients, blood were taken for analysis. Isolation of lymphocytes from blood to measure its gene expression profile
Time Frame
4 hours
Title
Transmembrane pressure
Description
Transmodular pressure changes were recorded every 15 minutes during dialysis
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years, gender not limited; Patients with clinical diagnosis of chronic renal insufficiency (CKD stage 5) requiring renal replacement therapy; Dialysis access was central venous catheter; 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: Patients with acute renal failure; Patients are participating in other clinical studies; Pregnancy or breastfeeding; Use of hemostatic or anticoagulant drugs in the last 1 week; Positive infectious serum markers for HIV, syphilis, hepatitis B, and hepatitis C; Presence of active infection; Allergy to dialyzers.
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

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A Comparative Study of Two Kinds of Hemodialysis Filters

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