BleedingClotParaNCT05440201
Coupling Between Clotting Characteristics in Chronic Hemodialysis Patients and the Hemodialyzer Patency
A study testing Amount of anticoagulant Clexane in people with Bleeding and Coagulation, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Twenty stable chronic hemodialysis patients are included and will undergo one, two, three or four midweek test dialysis sessions, depending on a flow chart to follow. All patients are started (week 1) with an anticoagulant Clexane 50IE/kg and are dialyzed with their regular dialyzer and dialysis machine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Coagulation
- What is being tested?
- Amount of anticoagulant Clexane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Apr 2023to 20 May 2023
- 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
- chronic hemodialysis patients
- well functioning vascular access
- hematocrit higher than 30%
Who cannot join
- known heparin allergy
- severe thrombocytopenia (platelets more than 50.000/µL)
- active infection
- treatment with vitamin K antagonists
Trial locations and contacts
1 site in 1 country.
About this study
Twenty stable chronic hemodialysis patients are included and will undergo one, two, three or four midweek test dialysis sessions, depending on a flow chart to follow.
All patients are started (week 1) with an anticoagulant Clexane 50IE/kg and are dialyzed with their regular dialyzer and dialysis machine. Depending on the results of measured clotting characteristics and of the dialyzer scanning (i.e. percentage open fibers), it is decided (via the flow chart) whether the patient gets a second session (and so on) with an adapted anticoagulation therapy to ameliorate fiber patency while limiting bleedings.
Read the detailed description
Twenty stable chronic hemodialysis (HD) patients with a well functioning vascular access will be included. Patients have a hematocrit higher than 30%, and have no known heparin allergy, no severe thrombocytopenia (platelets more than 50.000/µL) or active infection. Patients are not treated with vitamin K antagonists.
The study is limited to maximum four test sessions at midweek per patient. Patients are dialysed with their regular dialyzer on their regular dialysis machine. Patients will get a dialysis of 240min with blood flow 300mL/min and dialysate flow 500mL/min. Ultrafiltration is set according to the patient's needs. As usual, patients will get an administration of an anticoagulant in the dialysis circuit to avoid clotting of the extracorporeal circuit.
At the start of the first test session, patients receive the anticoagulant Clexane 20-30IE/kg (0.2-0.3mg/kg - rounded to 10).
In these 20 patients, clotting characteristics are measured by performing clotting tests, such as thrombin generation test, thrombo-elastogram with Rotem, Platelet Function Analysis (PFA), flow chamber, and the measurement of biochemical markers such as anti-thrombin-III (AT-III), p-selectin, and antiXa. For these measurements, blood is sampled predialysis, 30min after dialysis start, and post dialysis.
In order to link these clotting characteristics with dialyzer patency, the dialyzer will be scanned post dialysis with a gold standard micro Computed Tomography (CT) technique. At the end of the dialysis session, a standard rinsing procedure is applied. The dialyzer is then dried for 12-24 hours by continuous positive pressure ventilation in blood and dialysate compartment. During scanning, the dialyzer is mounted vertically on a rotating disc in front of the X-rays source. After image reconstruction, we get images of cross sections of the dialyzer. The non-blocked fibers are counted with an open source computer program used for biological image analysis. By comparing the number of non-blocked fibers with the total number of fibers in a non-used dialyzer, the percentage of fiber blocking can be derived.
By comparing the percentage of fiber blocking with the clotting characteristics in the patient, insight can be obtained in the value of the different clotting characteristics.
Based on the results of the first midweek session, it is decided (based on a flow chart) whether the patient will also get a second, third and eventual fourth dialysis test session at midweek with an adapted anticoagulation therapy to ameliorate fiber patency while limiting bleedings.
- Conditions
- Bleeding, Coagulation
- Being tested
- Amount of anticoagulant Clexane
- Medical subject headings
- Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amount of anticoagulant ClexaneOther
Change (increase/decrease) the amount of Clexane administered at the dialysis start.
| Study group | Role | What they receive |
|---|---|---|
| First test session | Experimental | For each patient, the anticoagulant Clexane 50IE/kg is administered in the venous line of the dialysis circuit once blood is detected by the dialysis machine. Receives: Other: Amount of anticoagulant Clexane |
| Second test session | Experimental | The dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session. Receives: Other: Amount of anticoagulant Clexane |
| Third test session | Experimental | The dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session. Receives: Other: Amount of anticoagulant Clexane |
| Fourth test session | Experimental | The dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session. Receives: Other: Amount of anticoagulant Clexane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialyzer fiber patency
Percentage of open fibers in de dialyzer post dialysis
Measured: 4 midweek sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start19 Apr 2023
- Primary completion20 May 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim Van Biesen, Prof dr, Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440201
- Sponsor's protocol ID
- UGent_ClotPara
- Acronym
- ClotPara
- Status last verified
- May 2023
- First submitted
- 27 Jun 2022
- Last updated
- 30 May 2023
- 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coupling Between Clotting Characteristics in Chronic Hemodialysis Patients and the Hemodialyzer Patency
- ClinicalTrials.gov ID
- NCT05440201
- Acronym / sponsor ID
- ClotPara / UGent_ClotPara
- Conditions
- Bleeding, Coagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 30 Jun 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.
Twenty stable chronic hemodialysis patients are included and will undergo one, two, three or four midweek test dialysis sessions, depending on a flow chart to follow.
All patients are started (week 1) with an anticoagulant Clexane 50IE/kg and are dialyzed with their regular dialyzer and dialysis machine. Depending on the results of measured clotting characteristics and of the dialyzer scanning (i.e. percentage open fibers), it is decided (via the flow chart) whether the patient gets a second session (and so on) with an adapted anticoagulation therapy to ameliorate fiber patency while limiting bleedings.
Detailed description
Twenty stable chronic hemodialysis (HD) patients with a well functioning vascular access will be included. Patients have a hematocrit higher than 30%, and have no known heparin allergy, no severe thrombocytopenia (platelets more than 50.000/µL) or active infection. Patients are not treated with vitamin K antagonists.
The study is limited to maximum four test sessions at midweek per patient. Patients are dialysed with their regular dialyzer on their regular dialysis machine. Patients will get a dialysis of 240min with blood flow 300mL/min and dialysate flow 500mL/min. Ultrafiltration is set according to the patient's needs. As usual, patients will get an administration of an anticoagulant in the dialysis circuit to avoid clotting of the extracorporeal circuit.
At the start of the first test session, patients receive the anticoagulant Clexane 20-30IE/kg (0.2-0.3mg/kg - rounded to 10).
In these 20 patients, clotting characteristics are measured by performing clotting tests, such as thrombin generation test, thrombo-elastogram with Rotem, Platelet Function Analysis (PFA), flow chamber, and the measurement of biochemical markers such as anti-thrombin-III (AT-III), p-selectin, and antiXa. For these measurements, blood is sampled predialysis, 30min after dialysis start, and post dialysis.
In order to link these clotting characteristics with dialyzer patency, the dialyzer will be scanned post dialysis with a gold standard micro Computed Tomography (CT) technique. At the end of the dialysis session, a standard rinsing procedure is applied. The dialyzer is then dried for 12-24 hours by continuous positive pressure ventilation in blood and dialysate compartment. During scanning, the dialyzer is mounted vertically on a rotating disc in front of the X-rays source. After image reconstruction, we get images of cross sections of the dialyzer. The non-blocked fibers are counted with an open source computer program used for biological image analysis. By comparing the number of non-blocked fibers with the total number of fibers in a non-used dialyzer, the percentage of fiber blocking can be derived.
By comparing the percentage of fiber blocking with the clotting characteristics in the patient, insight can be obtained in the value of the different clotting characteristics.
Based on the results of the first midweek session, it is decided (based on a flow chart) whether the patient will also get a second, third and eventual fourth dialysis test session at midweek with an adapted anticoagulation therapy to ameliorate fiber patency while limiting bleedings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First test session | Experimental | Other: Amount of anticoagulant ClexaneFor each patient, the anticoagulant Clexane 50IE/kg is administered in the venous line of the dialysis circuit once blood is detected by the dialysis machine. |
| Second test session | Experimental | Other: Amount of anticoagulant ClexaneThe dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session. |
| Third test session | Experimental | Other: Amount of anticoagulant ClexaneThe dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session. |
| Fourth test session | Experimental | Other: Amount of anticoagulant ClexaneThe dosis of Clexane is lowered or increased by 50%, depending on the results of the fiber patency and clotting characteristics of the previous session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic hemodialysis patients
- well functioning vascular access
- hematocrit higher than 30%
Key exclusion criteria (4 listed)
- known heparin allergy
- severe thrombocytopenia (platelets more than 50.000/µL)
- active infection
- treatment with vitamin K antagonists
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 |
|---|---|---|
| Amount of anticoagulant ClexaneChange (increase/decrease) the amount of Clexane administered at the dialysis start. | Other | First test session, Fourth test session, Second test session, Third test session |
Primary outcome
Dialyzer fiber patency
Time frame: 4 midweek sessions
Percentage of open fibers in de dialyzer post dialysis
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 30 May 2023.
- 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
UZ Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amount of anticoagulant Clexane in people with Bleeding 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 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 30 May 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 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?
Dialyzer fiber patency (time frame: 4 midweek sessions). 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 30 May 2023.