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.
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.
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 group | Role | What they receive |
|---|---|---|
| Group A(OCI-HF160+FX800HDF) | Experimental | Group A first used the hemodialysis filter OCI-HF160, then used FX800HDF. Receives: Device: OCI-HF160; Device: FX800HDF |
| Group B(FX800HDF+OCI-HF160) | Experimental | Group 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.
Filter coagulation grade 3
Filter coagulation grade 3 is a severe clotting events
Measured: 4 hours
Filter multiplexer residual volume <0.8
Filter multiplexer residual volume <0.8 is also a severe clotting events
Measured: 4 hours
Secondary outcomes (9)
Blood platelets
The normal value of blood platelets is 100×10^9/L~300×10^9/L
Measured: 4 hours
Hemoglobin
The normal values are 120-160g/L for adult males and 110-150g/L for adult females
Measured: 4 hours
Leukocytes
The normal value is 4×10^9/L~10×10^9/L
Measured: 4 hours
Blood coagulation factor TF
TF is the initiating factor of coagulation reaction
Measured: 4 hours
Blood coagulation factor FXII
Coagulation factor FXII is a protease involved in the blood coagulation pathway
Measured: 4 hours
Blood coagulation factor F1+2
Coagulation factor F1+2 can reflect thrombin activity
Measured: 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
Measured: 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
Measured: 4 hours
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.
- First posted12 Jun 2023
- Study start1 Mar 2021
- Primary completion31 Jul 2021
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UremiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhui Zhou, Chinese PLA General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover, Controlled Clinical Study of the Capillary High-Flux Hemodialysis Filters OCI-HF160 and FX800HDF
- ClinicalTrials.gov ID
- NCT05899283
- Acronym / sponsor ID
- S2021-171-01
- Conditions
- Uremia
- Keywords
- Hemodialysis Filter, OCI-HF160, FX800HDF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A(OCI-HF160+FX800HDF) | Experimental | Device: OCI-HF160, Device: FX800HDFGroup A first used the hemodialysis filter OCI-HF160, then used FX800HDF. |
| Group B(FX800HDF+OCI-HF160) | Experimental | Device: OCI-HF160, Device: FX800HDFGroup B first used the hemodialysis filter FX800HDF, and then used OCI-HF160. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCI-HF160Also: the Chengdu Ousai Hollow Fiber Membrane Hemodialysis Filter OCI-HF160OCI-HF160 are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood. | Device | Group A(OCI-HF160+FX800HDF), Group B(FX800HDF+OCI-HF160) |
| FX800HDFAlso: the Fresenius Hemodialysis Filter FX80FX800HDF are used in patients for hemofiltration, hemodialysis and hemodiafiltration, to correct solute and fluid imbalances in patients' blood. | Device | Group A(OCI-HF160+FX800HDF), Group B(FX800HDF+OCI-HF160) |
Primary outcome
Filter coagulation grade 3
Time frame: 4 hours
Filter coagulation grade 3 is a severe clotting events
Filter multiplexer residual volume <0.8
Time frame: 4 hours
Filter multiplexer residual volume <0.8 is also a severe clotting events
9 secondary outcomes
Blood platelets
Time frame: 4 hours
Hemoglobin
Time frame: 4 hours
Leukocytes
Time frame: 4 hours
Blood coagulation factor TF
Time frame: 4 hours
Blood coagulation factor FXII
Time frame: 4 hours
Blood coagulation factor F1+2
Time frame: 4 hours
Scanning electron microscope
Time frame: 4 hours
Single-cell transcriptome sequencing
Time frame: 4 hours
Transmembrane pressure
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.