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CompletedNCT05899283Updated Jun 12, 2023

A Comparative Study of Two Kinds of Hemodialysis Filters

An interventional study of OCI-HF160 and FX800HDF in Uremia, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-12.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Uremia

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Keywords

  • Hemodialysis Filter
  • OCI-HF160
  • FX800HDF
03

In context

Uremia

53 studies on the registry are indexed under Uremia; 10 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 38 interventional studies indexed under Uremia.

Browse Uremia studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 signed by the patient or authorized delegate had been obtained.

Exclusion criteria

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 , syphilis, , and ;
  6. Presence of active infection;
  7. Allergy to dialyzers.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Group A(OCI-HF160+FX800HDF)

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

    Device: OCI-HF160 · Device: FX800HDF

  • Experimental
    Group B(FX800HDF+OCI-HF160)

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

    Device: OCI-HF160 · Device: FX800HDF

Interventions

  • DeviceOCI-HF160

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

    Also known as: the Chengdu Ousai Hollow Fiber Membrane Hemodialysis Filter OCI-HF160

  • DeviceFX800HDF

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

    Also known as: the Fresenius Hemodialysis Filter FX80

06

What researchers measure

Primary outcomes

  1. Filter coagulation grade 3

    Filter coagulation grade 3 is a severe clotting events

    Time frame: 4 hours

  2. Filter multiplexer residual volume <0.8

    Filter multiplexer residual volume \<0.8 is also a severe clotting events

    Time frame: 4 hours

Secondary outcomes

  1. Blood platelets

    The normal value of blood platelets is 100×10\^9/L\~300×10\^9/L

    Time frame: 4 hours

  2. Hemoglobin

    The normal values are 120-160g/L for adult males and 110-150g/L for adult females

    Time frame: 4 hours

  3. Leukocytes

    The normal value is 4×10\^9/L\~10×10\^9/L

    Time frame: 4 hours

  4. Blood coagulation factor TF

    TF is the initiating factor of coagulation reaction

    Time frame: 4 hours

  5. Blood coagulation factor FXII

    Coagulation factor FXII is a protease involved in the blood coagulation pathway

    Time frame: 4 hours

  6. Blood coagulation factor F1+2

    Coagulation factor F1+2 can reflect thrombin activity

    Time frame: 4 hours

  7. Scanning electron microscope

    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

  8. 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

    Time frame: 4 hours

  9. Transmembrane pressure

    Transmodular pressure changes were recorded every 15 minutes during dialysis

    Time frame: 4 hours

07

Study locations

1 site
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Jul 2021, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2023
First posted
Jun 12, 2023
StartActual
Mar 1, 2021
Primary completionActual
Jul 31, 2021
CompletionActual
Oct 30, 2022
Last update
Jun 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05899283
Responsible party
Jianhui Zhou (Professor, Chinese PLA General Hospital) — Principal investigator
First posted
Jun 12, 2023
Start date
Mar 1, 2021
Primary completion
Jul 31, 2021
Completion
Oct 30, 2022
Last update
Jun 12, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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