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UremiaNCT05899283

A Comparative Study of Two Kinds of Hemodialysis Filters

A study testing OCI-HF160 and FX800HDF in people with Uremia, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Uremia
What is being tested?
OCI-HF160 and FX800HDF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Mar 2021to 30 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

Other trials in China

About this study

Official title: 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.

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.

Conditions
Uremia
Being tested
OCI-HF160, FX800HDF
Keywords
Hemodialysis Filter, OCI-HF160, FX800HDF
Medical subject headings
Uremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCI-HF160Device

    Also called the Chengdu Ousai Hollow Fiber Membrane Hemodialysis Filter OCI-HF160

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

  • FX800HDFDevice

    Also called the Fresenius Hemodialysis Filter FX80

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

Study groups in NCT05899283
Study groupRoleWhat they receive
Group A(OCI-HF160+FX800HDF)ExperimentalGroup A first used the hemodialysis filter OCI-HF160, then used FX800HDF.
Receives: Device: OCI-HF160; Device: FX800HDF
Group B(FX800HDF+OCI-HF160)ExperimentalGroup B first used the hemodialysis filter FX800HDF, and then used OCI-HF160.
Receives: Device: OCI-HF160; Device: FX800HDF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Filter coagulation grade 3

    Filter coagulation grade 3 is a severe clotting events

    Measured: 4 hours

  2. Filter multiplexer residual volume <0.8

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

    Measured: 4 hours

Secondary outcomes (9)
  1. Blood platelets

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

    Measured: 4 hours

  2. Hemoglobin

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

    Measured: 4 hours

  3. Leukocytes

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

    Measured: 4 hours

  4. Blood coagulation factor TF

    TF is the initiating factor of coagulation reaction

    Measured: 4 hours

  5. Blood coagulation factor FXII

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

    Measured: 4 hours

  6. Blood coagulation factor F1+2

    Coagulation factor F1+2 can reflect thrombin activity

    Measured: 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

    Measured: 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

    Measured: 4 hours

  9. Transmembrane pressure

    Transmodular pressure changes were recorded every 15 minutes during dialysis

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start1 Mar 2021
  3. Primary completion31 Jul 2021
  4. Study completion30 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05899283
Sponsor's protocol ID
S2021-171-01
Status last verified
Jun 2023
First submitted
31 Jan 2023
Last updated
12 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing OCI-HF160 and FX800HDF in people with Uremia, run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Filter coagulation grade 3 (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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