End Stage Renal DiseaseNCT04139525
Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With MCO PES-PVP (Theranova) Membrane
A study testing unfractionated heparin and 8% trisodium citrate in people with End Stage Renal Disease and Haemodialysis, run by Marija Malgaj Vrečko at 1 site in Slovenia.
Trial summary
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Haemodialysis, Anticoagulation
- What is being tested?
- unfractionated heparin and 8% trisodium citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Sep 2020to Dec 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
- patient on chronic hemodialysis
- age 18 years old or more
- being able to give an informed consent to participate in the survey
Who cannot join
- on therapeutic anticoagulation
- citrate or heparin contraindicated
- citrate or heparin intolerance
- acute renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With Medium Cut-off Polyarylethersulphone- Polyvinylpirrolidone (Theranova) Membrane
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).
Read the detailed description
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, β2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.
- Conditions
- End Stage Renal Disease, Haemodialysis, Anticoagulation
- Being tested
- unfractionated heparin, 8% trisodium citrate
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unfractionated heparinBiological
A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.
8% trisodium citrateBiological
8% trisodium citrate in the dose of 150 ml/h.
| Study group | Role | What they receive |
|---|---|---|
| unfractionated heparin and 8% trisodium citrate | Experimental | Unfractionated heparin and 8% trisodium citrate. Receives: Biological: unfractionated heparin; Biological: 8% trisodium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of beta-2 microglobulin
Overall and instantaneous clearance of beta-2 microglobulin.
Measured: At the end of each hemodialysis procedure.
Clearance of phosphate
Overall and instantaneous clearance of phosphate.
Measured: At the end of each hemodialysis procedure.
Serum concentration of C3a, C5a, myeloperoxidase and PF-4
Blood for the laboratory measurements will be taken from the arterial line.
Measured: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Secondary outcomes (5)
Clearance of urea
Overall and instantaneous clearance of urea.
Measured: At the end of each hemodialysis procedure.
Clearance of creatinine
Overall and instantaneous clearance of creatinine.
Measured: At the end of each hemodialysis procedure.
Clearance of p-cresol
Overall and instantaneous clearance of p-cresol.
Measured: At the end of each hemodialysis procedure.
White blood cell count
Blood for the laboratory measurements will be taken from the arterial line.
Measured: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Blood platelet count
Blood for the laboratory measurements will be taken from the arterial line.
Measured: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start15 Sep 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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 End Stage Renal DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The research will be performed as a prospective clinical trial. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marija Malgaj Vrečko
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marija Malgaj Vrečko, University Medical Centre Ljubljana
- Investigators
- Marija Malgaj Vrečko, MD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139525
- Sponsor's protocol ID
- 0120-11/2019/3
- Status last verified
- Jun 2022
- First submitted
- 12 Oct 2019
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vrecko MM, Pajek J, Buturovic-Ponikvar J. Use of regional citrate anticoagulation with medium cut-off membrane: pilot report. BMC Nephrol. 2022 Oct 27;23(1):346. doi: 10.1186/s12882-022-02960-y.
PubMed 36303108
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With Medium Cut-off Polyarylethersulphone- Polyvinylpirrolidone (Theranova) Membrane
- ClinicalTrials.gov ID
- NCT04139525
- Acronym / sponsor ID
- 0120-11/2019/3
- Conditions
- End Stage Renal Disease, Haemodialysis, Anticoagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Marija Malgaj VrečkoUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Oct 2019 (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.
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis with medium cut-off polyarylethersulphone-polyvinylpirrolidone membrane (Theranova®).
Detailed description
The purpose of the study is to compare the efficiency and biocompatibility of citrate and heparin anticoagulation during hemodialysis (HD) with PES-PVP membrane. The research will be performed as a prospective clinical trial and will include 35 patients. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate. We will compare the efficiency of both types of anticoagulation by measuring overall and instantaneous clearances of small, middle and protein-bound molecules (urea, creatinine, phosphate, β2-microglobulin, p-cresol). Biocompatibility will be evaluated by measuring activation of: complement (serum concentration of C3a and C5a), leukocytes (serum concentration of myeloperoxidase) and thrombocytes (serum concentration of PF4). We will also monitor complete blood count for occurrence of leukopenia and thrombocytopenia. After the HD electron microscopy of the membrane will be done in the proportion of included patients to evaluate adsorption of cells and formation of blood clots on the membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research will be performed as a prospective clinical trial. Every patient will have 2 HD procedures with PES-PVP membrane in a randomized order: 1 with unfractionated heparin (UFH) and 1 with 8% trisodium citrate.
| Arm | Type | Receives |
|---|---|---|
| unfractionated heparin and 8% trisodium citrate | Experimental | Biological: unfractionated heparin, Biological: 8% trisodium citrateUnfractionated heparin and 8% trisodium citrate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient on chronic hemodialysis
- age 18 years old or more
- being able to give an informed consent to participate in the survey
Key exclusion criteria (4 listed)
- on therapeutic anticoagulation
- citrate or heparin contraindicated
- citrate or heparin intolerance
- acute renal failure
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 |
|---|---|---|
| unfractionated heparinA bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis. | Biological | unfractionated heparin and 8% trisodium citrate |
| 8% trisodium citrate8% trisodium citrate in the dose of 150 ml/h. | Biological | unfractionated heparin and 8% trisodium citrate |
Primary outcome
Clearance of beta-2 microglobulin
Time frame: At the end of each hemodialysis procedure.
Overall and instantaneous clearance of beta-2 microglobulin.
Clearance of phosphate
Time frame: At the end of each hemodialysis procedure.
Overall and instantaneous clearance of phosphate.
Serum concentration of C3a, C5a, myeloperoxidase and PF-4
Time frame: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Blood for the laboratory measurements will be taken from the arterial line.
5 secondary outcomes
Clearance of urea
Time frame: At the end of each hemodialysis procedure.
Clearance of creatinine
Time frame: At the end of each hemodialysis procedure.
Clearance of p-cresol
Time frame: At the end of each hemodialysis procedure.
White blood cell count
Time frame: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Blood platelet count
Time frame: At the start, after 15 minutes and at the end of each hemodialysis procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 36303108Vrecko MM, Pajek J, Buturovic-Ponikvar J. Use of regional citrate anticoagulation with medium cut-off membrane: pilot report. BMC Nephrol. 2022 Oct 27;23(1):346. doi: 10.1186/s12882-022-02960-y.
- Individual participant dataSharing planned: No
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Marija Malgaj Vrečko, MD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unfractionated heparin and 8% trisodium citrate in people with End Stage Renal Disease and Haemodialysis, run by Marija Malgaj Vrečko at 1 site in Slovenia.
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: status not confirmed, as of the sponsor's last update on 7 Jun 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 Slovenia. 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?
Results are not available in the source record.
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?
Clearance of beta-2 microglobulin (time frame: At the end of each hemodialysis procedure.). The study lists 3 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 NCT04139525, 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 7 Jun 2022.