HemodialysisNCT04746391
Impact of Clotting on Dialyzer Efficiency
A study testing Dialyzer type and Dialysis duration in people with Hemodialysis and Coagulation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Coagulation within the dialyzer membrane fibres is an obvious biological sign of bio-incompatibility. To avoid clotting during extracorporeal treatment, an anticoagulant is added to the circuit, resulting in an increased risk for bleeding complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Coagulation
- What is being tested?
- Dialyzer type and Dialysis duration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 19 May 2021to 31 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- experienced stable dialysis sessions during the last 4 weeks
- double needle/lumen well-functioning vascular access
Who cannot join
- known coagulation disorder
- active inflammation
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of a Relation Between Dialyzer Clearance and Clotting in Hemodialyzer
Coagulation within the dialyzer membrane fibres is an obvious biological sign of bio-incompatibility. To avoid clotting during extracorporeal treatment, an anticoagulant is added to the circuit, resulting in an increased risk for bleeding complications. In addition, there is evidence that a substantial number of fibers can become blocked before this is reflected in routinely observed parameters, or in termination of the dialysis session. Little is known about the impact of such subclinical clotting on dialyzer performance in terms of solute clearance. Membrane clogging may influence both the diffusive and convective transport characteristics of the dialyzer membrane before leading to complete dialyzer clotting. In 2018, we described a method to objectively count the number of blocked fibres inside a dialyzer using a micro-CT scanning technique. In the present trial, we use this method to assess the number of open fibers post dialysis, and this for three different dialysis durations and in two different dialyzer types. Just before the termination of the dialysis session, dialyzer clearance is assessed for different solutes from concentration measurements in blood samples as taken from the dialyzer inlet and outlet line.
The aim of this randomized cross-over study is to objectively quantify the impact of blocked fibers on the performance of different dialyzer membranes: ATA™ (asymmetric triacetate) membrane in the Solacea™ dialyzer, and polysulfone membrane in the FX800Cordiax dialyzer, and this with a decreased anticoagulation dose.
Read the detailed description
This single centre, randomized cross-over study includes ten consecutive stable chronic hemodialysis (HD) patients who experienced stable dialysis sessions during the last 4 weeks, and had no known coagulation disorder, active inflammation or malignancy. Double-needle vascular access is achieved through a native arterio-venous fistula or a well-functioning double lumen tunnelled central venous catheter. Patients are followed during 6 consecutive midweek dialysis sessions. At midweek, patients receive only 1/4th of their regular brand of Low-Molecular Weight Heparin anticoagulation at the beginning of the dialysis session. All test sessions are performed with blood flow at 300mL/min and dialysate flow at 500mL/min in post dilution hemodiafiltration (HDF) mode (substitution flow 75mL/min). Ultrafiltration rates are set according to the patient's interdialytic weight gain and clinical status.
Patients are randomized for hemodialyzer type and dialysis duration:
- ATA™ Solacea 19H - 60min dialysis
- ATA™ Solacea 19H - 120min dialysis
- ATA™ Solacea 19H - 240min dialysis
- polysulfone FX800Cordiax - 60min dialysis
- polysulfone FX800Cordiax - 120min dialysis
- polysulfone FX800Cordiax - 240min dialysis
Just before the termination of the 6 experimental midweek sessions, blood is sampled from the inlet and outlet blood lines. Blood samples are immediately centrifuged and serum vials are stored at -80°C until batch analysis. Post dialysis, dialyzers are rinsed and dried and scanned with micro computed tomography (CT) to count the number of open fibers.
- Conditions
- Hemodialysis, Coagulation
- Being tested
- Dialyzer type, Dialysis duration
- Keywords
- Hemodialyzer, Fibre Clotting
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialyzer typeDevice
Fiber blocking and dialyzer clearance is calculated in two different commercially available dialyzers
Dialysis durationOther
Fiber blocking and dialyzer clearance is calculated for three different dialysis durations
| Study group | Role | What they receive |
|---|---|---|
| Solacea_60min | Experimental | * blood sampling from dialyzer inlet and outlet line at 60min, just before dialysis termination
* microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers Receives: Device: Dialyzer type; Other: Dialysis duration |
| Solacea_120min | Experimental | * blood sampling from dialyzer inlet and outlet line at 120min, just before dialysis termination
* microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers Receives: Device: Dialyzer type; Other: Dialysis duration |
| Solacea_240min | Experimental | * blood sampling from dialyzer inlet and outlet line at 240min, just before dialysis termination
* microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers Receives: Device: Dialyzer type; Other: Dialysis duration |
| FX800_60min | Experimental | * blood sampling from dialyzer inlet and outlet line at 60min, just before dialysis termination
* microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers Receives: Device: Dialyzer type; Other: Dialysis duration |
| FX800_120min | Experimental | * blood sampling from dialyzer inlet and outlet line at 120min, just before dialysis termination
* microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers Receives: Device: Dialyzer type; Other: Dialysis duration |
| FX800_240min | Experimental | * blood sampling from dialyzer inlet and outlet line at 240min, just before dialysis termination
* microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers Receives: Device: Dialyzer type; Other: Dialysis duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibre blocking in hemodialyzers
Fibre blocking as assessed post dialysis by a reference microCT scanning technique
Measured: 6 weeks
Hemodialyzer performance
Dialyzer performance based on calculated clearances for different solutes
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start19 May 2021
- Primary completion1 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Wim Van Biesen, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746391
- Sponsor's protocol ID
- UGent_FiberClotting_2
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanommeslaeghe F, Van Biesen W, Dierick M, Boone M, Dhondt A, Eloot S. Micro-computed tomography for the quantification of blocked fibers in hemodialyzers. Sci Rep. 2018 Feb 8;8(1):2677. doi: 10.1038/s41598-018-20898-w.
PubMed 29422614
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Relation Between Dialyzer Clearance and Clotting in Hemodialyzer
- ClinicalTrials.gov ID
- NCT04746391
- Acronym / sponsor ID
- UGent_FiberClotting_2
- Conditions
- Hemodialysis, Coagulation
- Keywords
- Hemodialyzer, Fibre Clotting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 19 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 9 Feb 2021 (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.
Coagulation within the dialyzer membrane fibres is an obvious biological sign of bio-incompatibility. To avoid clotting during extracorporeal treatment, an anticoagulant is added to the circuit, resulting in an increased risk for bleeding complications. In addition, there is evidence that a substantial number of fibers can become blocked before this is reflected in routinely observed parameters, or in termination of the dialysis session. Little is known about the impact of such subclinical clotting on dialyzer performance in terms of solute clearance. Membrane clogging may influence both the diffusive and convective transport characteristics of the dialyzer membrane before leading to complete dialyzer clotting. In 2018, we described a method to objectively count the number of blocked fibres inside a dialyzer using a micro-CT scanning technique. In the present trial, we use this method to assess the number of open fibers post dialysis, and this for three different dialysis durations and in two different dialyzer types. Just before the termination of the dialysis session, dialyzer clearance is assessed for different solutes from concentration measurements in blood samples as taken from the dialyzer inlet and outlet line.
The aim of this randomized cross-over study is to objectively quantify the impact of blocked fibers on the performance of different dialyzer membranes: ATA™ (asymmetric triacetate) membrane in the Solacea™ dialyzer, and polysulfone membrane in the FX800Cordiax dialyzer, and this with a decreased anticoagulation dose.
Detailed description
This single centre, randomized cross-over study includes ten consecutive stable chronic hemodialysis (HD) patients who experienced stable dialysis sessions during the last 4 weeks, and had no known coagulation disorder, active inflammation or malignancy. Double-needle vascular access is achieved through a native arterio-venous fistula or a well-functioning double lumen tunnelled central venous catheter. Patients are followed during 6 consecutive midweek dialysis sessions. At midweek, patients receive only 1/4th of their regular brand of Low-Molecular Weight Heparin anticoagulation at the beginning of the dialysis session. All test sessions are performed with blood flow at 300mL/min and dialysate flow at 500mL/min in post dilution hemodiafiltration (HDF) mode (substitution flow 75mL/min). Ultrafiltration rates are set according to the patient's interdialytic weight gain and clinical status.
Patients are randomized for hemodialyzer type and dialysis duration:
- ATA™ Solacea 19H - 60min dialysis
- ATA™ Solacea 19H - 120min dialysis
- ATA™ Solacea 19H - 240min dialysis
- polysulfone FX800Cordiax - 60min dialysis
- polysulfone FX800Cordiax - 120min dialysis
- polysulfone FX800Cordiax - 240min dialysis
Just before the termination of the 6 experimental midweek sessions, blood is sampled from the inlet and outlet blood lines. Blood samples are immediately centrifuged and serum vials are stored at -80°C until batch analysis. Post dialysis, dialyzers are rinsed and dried and scanned with micro computed tomography (CT) to count the number of open fibers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Solacea_60min | Experimental | Device: Dialyzer type, Other: Dialysis duration* blood sampling from dialyzer inlet and outlet line at 60min, just before dialysis termination * microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers |
| Solacea_120min | Experimental | Device: Dialyzer type, Other: Dialysis duration* blood sampling from dialyzer inlet and outlet line at 120min, just before dialysis termination * microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers |
| Solacea_240min | Experimental | Device: Dialyzer type, Other: Dialysis duration* blood sampling from dialyzer inlet and outlet line at 240min, just before dialysis termination * microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers |
| FX800_60min | Experimental | Device: Dialyzer type, Other: Dialysis duration* blood sampling from dialyzer inlet and outlet line at 60min, just before dialysis termination * microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers |
| FX800_120min | Experimental | Device: Dialyzer type, Other: Dialysis duration* blood sampling from dialyzer inlet and outlet line at 120min, just before dialysis termination * microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers |
| FX800_240min | Experimental | Device: Dialyzer type, Other: Dialysis duration* blood sampling from dialyzer inlet and outlet line at 240min, just before dialysis termination * microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- experienced stable dialysis sessions during the last 4 weeks
- double needle/lumen well-functioning vascular access
Key exclusion criteria (3 listed)
- known coagulation disorder
- active inflammation
- malignancy
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 |
|---|---|---|
| Dialyzer typeFiber blocking and dialyzer clearance is calculated in two different commercially available dialyzers | Device | FX800_120min, FX800_240min, FX800_60min, Solacea_120min, Solacea_240min, Solacea_60min |
| Dialysis durationFiber blocking and dialyzer clearance is calculated for three different dialysis durations | Other | FX800_120min, FX800_240min, FX800_60min, Solacea_120min, Solacea_240min, Solacea_60min |
Primary outcome
Fibre blocking in hemodialyzers
Time frame: 6 weeks
Fibre blocking as assessed post dialysis by a reference microCT scanning technique
Hemodialyzer performance
Time frame: 6 weeks
Dialyzer performance based on calculated clearances for different solutes
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 19 Sep 2024.
- Background: PubMed 29422614Vanommeslaeghe F, Van Biesen W, Dierick M, Boone M, Dhondt A, Eloot S. Micro-computed tomography for the quantification of blocked fibers in hemodialyzers. Sci Rep. 2018 Feb 8;8(1):2677. doi: 10.1038/s41598-018-20898-w.
- Individual participant dataSharing planned: No
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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.
Wim Van Biesen principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialyzer type and Dialysis duration in people with Hemodialysis and Coagulation, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 3 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 19 Sep 2024. 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 Belgium. 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?
Fibre blocking in hemodialyzers (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT04746391, which also lists 1 linked publication.
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 19 Sep 2024.