HemodialysisNCT05204810
Optimisation of Anticoagulation in Patients on Nocturnal Hemodialysis
A study testing Anticoagulation strategy, Blood sampling and Scanning of hemodialyzer with micro-computed tomography in people with Hemodialysis and Coagulation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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… 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?
- Anticoagulation strategy, Blood sampling and Scanning of hemodialyzer with micro-computed tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2022to 1 Apr 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 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
- nocturnal in-centre hemodialysis
- well functioning vascular access
Who cannot join
- known coagulation disorder
- active inflammation
- malignancy
- no coumarin-derived medication
Trial locations and contacts
1 site in 1 country.
About this study
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.
In standard hemodialysis of 4 hours, the anticoagulant is administered at the beginning of dialysis. For nocturnal hemodialysis, there is no hard evidence whether anticoagulation should be administered only at the dialysis start or with an extra dosing halfway the dialysis session.
The aim of this randomized cross-over study is to objectively quantify the number of patent fibers after nocturnal dialysis in two different settings: anticoagulation only at the dialysis start, and anticoagulation divided over two time points, i.e. dialysis start and halfway dialysis.
Read the detailed description
This single centre, randomized cross-over study includes twenty stable chronic nocturnal hemodialysis patients with no coagulation disorder, active inflammation or chronic cumarin-derived medication.
Patients are randomized over 2 study arms. Each patient is dialyzed over 480min (at midweek) with 2 different settings: anticoagulation only at the dialysis start, and anticoagulation divided over two time points, i.e. dialysis start and halfway dialysis.
For each patient, the dialyzer, the dialysis mode (hemodialysis or hemodiafiltration) and the dialysis settings (blood flow, dialysate flow and substitution flow) are those as currently used by the patient during in-centre nocturnal dialysis.
To determine antiXa, blood samples are taken from the inlet dialysis line at the dialysis start (i.e. 5min after administration of the anticoagulant) and at 1h, 4h and 8h after dialysis start. During the session with 2 anticoagulant administrations, an extra blood sample is taken before as well as after the second anticoagulant administration.
Before the first test session, 1 blood sample is taken to determine antithrombin-III (AT-III).
In order to quantify dialyzer performance in terms of number of patent fibers, dialyzers are scanned after dialysis, using a glod standard non-invasive micro-CT technique.
Therefore, at the end of the dialysis session, a standard rinsing procedure of the hemodialyzer is performed using exact 300mL rinsing solution. Next, the hemodialyzer is dried using continuous positive pressure ventilation. Dialyzer fibre blocking is visualized in the dialyzer outlet potting using a 3D CT scanning technique on micrometer resolution. HECTOR is a High Energy CT scanner Optimized for Research, built by the Ghent University Centre for X-ray Tomography (UGCT) in collaboration with the UGCT spin-off company XRE (Gent, Belgium). In front of the X-ray source, the dialyzer is mounted vertically on a precision rotation stage, and radiographies were recorded over 360° with an angular interval of 0.15°. Scan conditions are optimized to maximize the signal-to-noise ratio based on the sample size and structure, and the scanner properties. The tube voltage is set at 80kV, at a power of 20 Watts, the maximal power that allowed imaging at a resolution of 25μm. A total of 2401 projections are recorded with 500ms exposure each, resulting in a total exposure time of 20 minutes. Acquired images at 0 (projection 1) and 360° (projection 2401) are compared to exclude movement of the hemodialyzer during the scanning process. Reconstruction of the raw projection data is performed with the Octopus Reconstruction software package, licensed by XRE23.
The non-blocked fibers are counted in the central cross-section of the dialyzer outlet potting in a computer-based way using the Fiji image processing toolkit of ImageJ analysis software (ImageJ 1.51H, NIH, Bethesda, USA), an open-source platform for biological-image analysis. By comparing the number of non-blocked fibers in used versus non-used dialyzers, the percentage of fiber blocking can be calculated.
By comparing the number of open fibers between the 2 test sessions (1 versus 2 anticoagulant administrations), the difference can objectively be scored for prolonged (nocturnal) dialysis.
- Conditions
- Hemodialysis, Coagulation
- Being tested
- Anticoagulation strategy, Blood sampling, Scanning of hemodialyzer with micro-computed tomography
- Keywords
- Hemodialyzer, Fibre Clotting, Nocturnal dialysis
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation strategyOther
For each session of this cross-over study, a different anticoagulation therapy is used: either 1 dose of anticoagulant or 2 doses of anticoagulant
Blood samplingOther
During the study sessions, blood sampling is performed from the arterial blood line at different time points (5min, 60min, 240min and at the dialysis end)
Scanning of hemodialyzer with micro-computed tomographyOther
After the study sessions, the used hemodialyzers are scanned using a gold standard micro computed tomography technique.
| Study group | Role | What they receive |
|---|---|---|
| Night_1dosis | Experimental | * anticoagulation at dialysis start
* blood sampling 5min after start dosis, and at 1h, 4h and 8h after dialysis start
* microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers Receives: Other: Anticoagulation strategy; Other: Blood sampling; Other: Scanning of hemodialyzer with micro-computed tomography |
| Night_2doses | Experimental | * anticoagulation split over dialysis start and halfway dialysis (after 4h)
* blood sampling 5min after start dosis, and at 1h, 4h (1 sample before and 1 sample after the extra anticoagulant dosis) and 8h after dialysis start
* microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers Receives: Other: Anticoagulation strategy; Other: Blood sampling; Other: Scanning of hemodialyzer with micro-computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of open fibers in hemodialyzer
By scanning the hemodialyzers post dialysis using a reference micro-CT scanning technique, images are obtained from dialyzer cross-sections. Black dots can be counted as open fiber. By counting the number of open fibers and relating this number with the total numerb of fibers in sterile dialyzers, the percentage of open fibers can be quantified.
Measured: 2 weeks
Secondary outcomes (1)
Absolute value and change of the clotting parameter antiXa at different time points during dialysis
AntiXa (i.e. a measure to indicate anticoagulation by low molecular weight heparins) is followed in the patient at dialysis start and after 1, 4, and 8h.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Feb 2022
- Primary completion1 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- 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
- 20 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, Prof dr, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204810
- Sponsor's protocol ID
- UGent_ClotNight
- Status last verified
- Dec 2021
- First submitted
- 9 Dec 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Anticoagulation in Patients on Nocturnal Hemodialysis
- ClinicalTrials.gov ID
- NCT05204810
- Acronym / sponsor ID
- UGent_ClotNight
- Conditions
- Hemodialysis, Coagulation
- Keywords
- Hemodialyzer, Fibre Clotting, Nocturnal dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 24 Jan 2022 (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.
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.
In standard hemodialysis of 4 hours, the anticoagulant is administered at the beginning of dialysis. For nocturnal hemodialysis, there is no hard evidence whether anticoagulation should be administered only at the dialysis start or with an extra dosing halfway the dialysis session.
The aim of this randomized cross-over study is to objectively quantify the number of patent fibers after nocturnal dialysis in two different settings: anticoagulation only at the dialysis start, and anticoagulation divided over two time points, i.e. dialysis start and halfway dialysis.
Detailed description
This single centre, randomized cross-over study includes twenty stable chronic nocturnal hemodialysis patients with no coagulation disorder, active inflammation or chronic cumarin-derived medication.
Patients are randomized over 2 study arms. Each patient is dialyzed over 480min (at midweek) with 2 different settings: anticoagulation only at the dialysis start, and anticoagulation divided over two time points, i.e. dialysis start and halfway dialysis.
For each patient, the dialyzer, the dialysis mode (hemodialysis or hemodiafiltration) and the dialysis settings (blood flow, dialysate flow and substitution flow) are those as currently used by the patient during in-centre nocturnal dialysis.
To determine antiXa, blood samples are taken from the inlet dialysis line at the dialysis start (i.e. 5min after administration of the anticoagulant) and at 1h, 4h and 8h after dialysis start. During the session with 2 anticoagulant administrations, an extra blood sample is taken before as well as after the second anticoagulant administration.
Before the first test session, 1 blood sample is taken to determine antithrombin-III (AT-III).
In order to quantify dialyzer performance in terms of number of patent fibers, dialyzers are scanned after dialysis, using a glod standard non-invasive micro-CT technique.
Therefore, at the end of the dialysis session, a standard rinsing procedure of the hemodialyzer is performed using exact 300mL rinsing solution. Next, the hemodialyzer is dried using continuous positive pressure ventilation. Dialyzer fibre blocking is visualized in the dialyzer outlet potting using a 3D CT scanning technique on micrometer resolution. HECTOR is a High Energy CT scanner Optimized for Research, built by the Ghent University Centre for X-ray Tomography (UGCT) in collaboration with the UGCT spin-off company XRE (Gent, Belgium). In front of the X-ray source, the dialyzer is mounted vertically on a precision rotation stage, and radiographies were recorded over 360° with an angular interval of 0.15°. Scan conditions are optimized to maximize the signal-to-noise ratio based on the sample size and structure, and the scanner properties. The tube voltage is set at 80kV, at a power of 20 Watts, the maximal power that allowed imaging at a resolution of 25μm. A total of 2401 projections are recorded with 500ms exposure each, resulting in a total exposure time of 20 minutes. Acquired images at 0 (projection 1) and 360° (projection 2401) are compared to exclude movement of the hemodialyzer during the scanning process. Reconstruction of the raw projection data is performed with the Octopus Reconstruction software package, licensed by XRE23.
The non-blocked fibers are counted in the central cross-section of the dialyzer outlet potting in a computer-based way using the Fiji image processing toolkit of ImageJ analysis software (ImageJ 1.51H, NIH, Bethesda, USA), an open-source platform for biological-image analysis. By comparing the number of non-blocked fibers in used versus non-used dialyzers, the percentage of fiber blocking can be calculated.
By comparing the number of open fibers between the 2 test sessions (1 versus 2 anticoagulant administrations), the difference can objectively be scored for prolonged (nocturnal) dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Night_1dosis | Experimental | Other: Anticoagulation strategy, Other: Blood sampling, Other: Scanning of hemodialyzer with micro-computed tomography* anticoagulation at dialysis start * blood sampling 5min after start dosis, and at 1h, 4h and 8h after dialysis start * microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
| Night_2doses | Experimental | Other: Anticoagulation strategy, Other: Blood sampling, Other: Scanning of hemodialyzer with micro-computed tomography* anticoagulation split over dialysis start and halfway dialysis (after 4h) * blood sampling 5min after start dosis, and at 1h, 4h (1 sample before and 1 sample after the extra anticoagulant dosis) and 8h after dialysis start * microCT scanning of rinsed and dried dialyzer, 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 (4 listed)
- 18 years or older
- experienced stable dialysis sessions during the last 4 weeks
- nocturnal in-centre hemodialysis
- well functioning vascular access
Key exclusion criteria (4 listed)
- known coagulation disorder
- active inflammation
- malignancy
- no coumarin-derived medication
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 |
|---|---|---|
| Anticoagulation strategyFor each session of this cross-over study, a different anticoagulation therapy is used: either 1 dose of anticoagulant or 2 doses of anticoagulant | Other | Night_1dosis, Night_2doses |
| Blood samplingDuring the study sessions, blood sampling is performed from the arterial blood line at different time points (5min, 60min, 240min and at the dialysis end) | Other | Night_1dosis, Night_2doses |
| Scanning of hemodialyzer with micro-computed tomographyAfter the study sessions, the used hemodialyzers are scanned using a gold standard micro computed tomography technique. | Other | Night_1dosis, Night_2doses |
Primary outcome
Percentage of open fibers in hemodialyzer
Time frame: 2 weeks
By scanning the hemodialyzers post dialysis using a reference micro-CT scanning technique, images are obtained from dialyzer cross-sections. Black dots can be counted as open fiber. By counting the number of open fibers and relating this number with the total numerb of fibers in sterile dialyzers, the percentage of open fibers can be quantified.
1 secondary outcome
Absolute value and change of the clotting parameter antiXa at different time points during dialysis
Time frame: 2 weeks
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 24 May 2022.
- 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, Prof dr 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 Anticoagulation strategy, Blood sampling and Scanning of hemodialyzer with micro-computed tomography 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 4 inclusion and 4 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 24 May 2022. 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?
Percentage of open fibers in hemodialyzer (time frame: 2 weeks). 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 24 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.