HemodiafiltrationNCT05280106
Citrate Dialysate in Online Hemodialfiltration
A study testing Pre-dilution online hemodiafiltration with citrate dialysate and Post-dilution hemodiafiltration with citrate dialysate in people with Hemodiafiltration and Heparin, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 2 sites in Thailand.
Trial summary
Online hemodiafiltration (Ol-HDF) is increasingly being used for patients on chronic dialysis due to in its superiority compared with standard hemodialysis HDF. In addition to an excellent clearance of small molecules, oL-HDF has more advantages by providing both diffusion and convection modalities for an additional… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodiafiltration, Heparin, Haemodialysis
- What is being tested?
- Pre-dilution online hemodiafiltration with citrate dialysate and Post-dilution hemodiafiltration with citrate dialysate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Feb 2022to 30 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable condition
- Having been under HD for at least three months
- he vascular access should have blood flow ≥ 300 mL/min.
Who cannot join
- no heparin use during HD
- refusal to participate,
- intolerance or allergy to citrate
- concurrent infection
- poor life expectancy due to metastatic cancer, severe cirrhosis and AIDS.
- patients vascular access modification,
- patients affected by chronic liver disease, active neoplastic or inflammatory disease were excluded as well as patients receiving immunosuppressive or anti-inflammatory drugs.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of Medicine ,Vajira hospital,Navamindradhiraj University
Bangkok, 10300
Faculty of Medicine ,Vajira Hospital
Bangkok, 10300
About this study
Official title: Comparison of Citrate Dialysate in Predilution and Postdilution Online Hemodiafiltration : Effect on Clot Formation and Adequacy of Dialysis in Hemodialysis Patients
Online hemodiafiltration (Ol-HDF) is increasingly being used for patients on chronic dialysis due to in its superiority compared with standard hemodialysis HDF. In addition to an excellent clearance of small molecules, oL-HDF has more advantages by providing both diffusion and convection modalities for an additional clearance of medium-size molecules. Furthermore, OL-HDF has been associated with not only better hemodynamic tolerance and biocompatibility , but may even include better survival.with reduction of proinflammatory cytokines and proinflammatory circulating cells , as well as with better control of B2MG levels .Ol-HDF is classified into 2 types according to the mode of addition of the substitution fluid: pre-dilution OL-HDF (pre-HDF) and post-dilution OL-HDF (post-HDF); Post-HDF was associated with significantly higher removal rates of β2-MG than HD. Postdilution HDF is the most effective way to maximize molecule clearance .Post-HDF was associated with significantly higher removal rate of α1-MG, and also significantly higher albumin leakage, than HD and pre-HDF. However, blood concentrations can be elevated using HDF, which can cause thrombosis. On the other hand, predilution HDF can resolve this problem but requires about three times more purified water than postdilution HDF and may not elicit maximal clearance.
Read the detailed description
Heparin is the most routinely used anticoagulant in hemodialysis. However, it exposes the patient to the risk of bleeding complications and can induce thrombocytopenia. Furthermore, long-term use of heparin induces biological and clinical complications (osteoporosis, dyslipidemia, hyperkalemia) . Regional citrate anticoagulation is a good alternative to heparin use in hemodialysis for patients with increased bleeding risk , but its implementation in bicarbonate hemodialysis (BHD) is laborious and cumbersome: severe side effects can occur due to citrate metabolism and difficulties in adaptation of calcium infusion into the venous line .Therefore, the use of citrate as a dialysis buffer instead of acetate has proven a safe alternative to acetate-containing bicarbonate dialysis and on-line hemodiafiltration without significant hypocalcemia or clinically important coagulation issues.The aim of the present study is the comparison of the patency of the dialyzer ,the quality of life and blood parameters between pre and potdiltuiotn Ol-HDF with citrate dialysate (CD). No study to date has previously compared the use of citrate dialysate between these two modalities in oL-HDF.
- Conditions
- Hemodiafiltration, Heparin, Haemodialysis, Citrate Reaction
- Being tested
- Pre-dilution online hemodiafiltration with citrate dialysate, Post-dilution hemodiafiltration with citrate dialysate
- Keywords
- online hemodialfiltration, hemodialysis, citrate, adequacy of dialysis, heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-dilution online hemodiafiltration with citrate dialysateProcedure or surgery
After enrollment, all patients began a 2-week run-in period with conventional dialysis fluid containing acetate and the lowest dose of unfractionated heparin. The investigator titrated the heparin dose by reducing the dose step by step, 25% in each step, until the final minimal dose was achieved. The experimental study consisted of 3 phases, 4 weeks in each phase, and the phases were separated by 1-week washout periods. Phase 1 used CD with 50% of the heparin dose of the baseline. Phases 2 and 3 used 25% heparin and no heparin, respectively. New dialyzers were introduced at the beginning of each phase and the heparin dose was resumed during the washout phase. The calcium concentration in the dialysis fluid was kept constant (1.5 mmol/L) to allow evaluation of the effect of CD on calcium balance
Post-dilution hemodiafiltration with citrate dialysateProcedure or surgery
same protocol with post-dilution Ol-HDF in these same patients for the later 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pre-dilution online hemodiafiltration | Experimental | The study was conducted for a 28-week period in two phases: For the first 12 weeks, all of the patients were subjected to CD with pre-dilution oL-HDF.After enrollment, all patients began a 2-week run-in period with conventional dialysis fluid containing acetate and the lowest dose of unfractionated heparin. The investigator titrated the heparin dose by reducing the dose step by step, 25% in each step, until the final minimal dose was achieved. The experimental study consisted of 3 phases, 4 weeks in each phase, and the phases were separated by 1-week washout periods. The second phase will run after finishing the first phase with the same protocol but with post-dilution online HDF.There will be 2 weeks washout period before starting this phase Receives: Procedure: Pre-dilution online hemodiafiltration with citrate dialysate; Procedure: Post-dilution hemodiafiltration with citrate dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
clotting score between pre and post dilution online-hemodiafiltration
5 grades of clotting score, Grade 1;No or very little residual blood in the filters.Grade 1;Residual blood in less than 10% of the fibers. Grade 2; Residual blood 10-25%. Grade 3; Residual blood 25-50%.Grade 4 ,Residual blood > 50%
Measured: 28 weeks
Secondary outcomes (5)
quality of life between pre and post dilution online-hemodiafiltration
KDQOL-sf score;0-100.Higher scores reflect better quality of life
Measured: 28 weeks
adequacy of dialysis between pre and post dilution online-hemodiafiltration
Kt/V
Measured: 28 weeks
calcium level between pre and post dilution online-hemodiafiltration
serum calcium predialysis in midweek of each phase
Measured: 28 weeks
phosphorus level between pre and post dilution online-hemodiafiltration
serum calcium predialysis in midweek of each phase
Measured: 28 weeks
intact parathyroid level between pre and post dilution online-hemodiafiltration
serum parathyroid level in midweek of each phase
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Feb 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HemodiafiltrationStudies 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
- One group interrupted times-series design (ITS)
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280106
- Sponsor's protocol ID
- 080/64
- Status last verified
- Feb 2023
- First submitted
- 6 Mar 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thaweethamcharoen T, Srimongkol W, Noparatayaporn P, Jariyayothin P, Sukthinthai N, Aiyasanon N, Kitisriworapan P, Jantarakana K, Vasuvattakul S. Validity and Reliability of KDQOL-36 in Thai Kidney Disease Patient. Value Health Reg Issues. 2013 May;2(1):98-102. doi: 10.1016/j.vhri.2013.02.011. Epub 2013 Mar 26.
PubMed 29702860Canaud B, Bosc JY, Leray H, Stec F, Argiles A, Leblanc M, Mion C. On-line haemodiafiltration: state of the art. Nephrol Dial Transplant. 1998;13 Suppl 5:3-11. doi: 10.1093/ndt/13.suppl_5.3.
PubMed 9623523Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int. 2006 Jun;69(11):2087-93. doi: 10.1038/sj.ki.5000447.
PubMed 16641921Guth HJ, Gruska S, Kraatz G. On-line production of ultrapure substitution fluid reduces TNF-alpha- and IL-6 release in patients on hemodiafiltration therapy. Int J Artif Organs. 2003 Mar;26(3):181-7. doi: 10.1177/039139880302600301.
PubMed 12703882Canaud B, Wizemann V, Pizzarelli F, Greenwood R, Schultze G, Weber C, Falkenhagen D. Cellular interleukin-1 receptor antagonist production in patients receiving on-line haemodiafiltration therapy. Nephrol Dial Transplant. 2001 Nov;16(11):2181-7. doi: 10.1093/ndt/16.11.2181.
PubMed 11682665Carracedo J, Merino A, Nogueras S, Carretero D, Berdud I, Ramirez R, Tetta C, Rodriguez M, Martin-Malo A, Aljama P. On-line hemodiafiltration reduces the proinflammatory CD14+CD16+ monocyte-derived dendritic cells: A prospective, crossover study. J Am Soc Nephrol. 2006 Aug;17(8):2315-21. doi: 10.1681/ASN.2006020105. Epub 2006 Jul 6.
PubMed 16825330Lin CL, Yang CW, Chiang CC, Chang CT, Huang CC. Long-term on-line hemodiafiltration reduces predialysis beta-2-microglobulin levels in chronic hemodialysis patients. Blood Purif. 2001;19(3):301-7. doi: 10.1159/000046958.
PubMed 11244190Kurihara Y, Hosoya H, Kishihara R, Yoshinaga M, Iwadate Y, Yamauchi F, Saito T, Sakurai K. Comparison of the effects of pre-dilution and post-dilution online hemodiafiltration on the levels of inflammatory markers, lymphocytes, and platelets. J Artif Organs. 2022 Mar;25(1):59-65. doi: 10.1007/s10047-021-01281-5. Epub 2021 Jun 14.
PubMed 34128110Tsuchida K, Minakuchi J. Clinical benefits of predilution on-line hemodiafiltration. Blood Purif. 2013;35 Suppl 1:18-22. doi: 10.1159/000346221. Epub 2013 Feb 25.
PubMed 23466373Hottelart C, Achard JM, Moriniere P, Zoghbi F, Dieval J, Fournier A. Heparin-induced hyperkalemia in chronic hemodialysis patients: comparison of low molecular weight and unfractionated heparin. Artif Organs. 1998 Jul;22(7):614-7. doi: 10.1046/j.1525-1594.1998.06204.x.
PubMed 9684701Aniort J, Petitclerc T, Creput C. Safe use of citric acid-based dialysate and heparin removal in postdilution online hemodiafiltration. Blood Purif. 2012;34(3-4):336-43. doi: 10.1159/000345342. Epub 2013 Jan 9.
PubMed 23306782
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Citrate Dialysate in Predilution and Postdilution Online Hemodiafiltration : Effect on Clot Formation and Adequacy of Dialysis in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05280106
- Acronym / sponsor ID
- 080/64
- Conditions
- Hemodiafiltration, Heparin, Haemodialysis, Citrate Reaction
- Keywords
- online hemodialfiltration, hemodialysis, citrate, adequacy of dialysis, heparin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Mar 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.
Online hemodiafiltration (Ol-HDF) is increasingly being used for patients on chronic dialysis due to in its superiority compared with standard hemodialysis HDF. In addition to an excellent clearance of small molecules, oL-HDF has more advantages by providing both diffusion and convection modalities for an additional clearance of medium-size molecules. Furthermore, OL-HDF has been associated with not only better hemodynamic tolerance and biocompatibility , but may even include better survival.with reduction of proinflammatory cytokines and proinflammatory circulating cells , as well as with better control of B2MG levels .Ol-HDF is classified into 2 types according to the mode of addition of the substitution fluid: pre-dilution OL-HDF (pre-HDF) and post-dilution OL-HDF (post-HDF); Post-HDF was associated with significantly higher removal rates of β2-MG than HD. Postdilution HDF is the most effective way to maximize molecule clearance .Post-HDF was associated with significantly higher removal rate of α1-MG, and also significantly higher albumin leakage, than HD and pre-HDF. However, blood concentrations can be elevated using HDF, which can cause thrombosis. On the other hand, predilution HDF can resolve this problem but requires about three times more purified water than postdilution HDF and may not elicit maximal clearance.
Detailed description
Heparin is the most routinely used anticoagulant in hemodialysis. However, it exposes the patient to the risk of bleeding complications and can induce thrombocytopenia. Furthermore, long-term use of heparin induces biological and clinical complications (osteoporosis, dyslipidemia, hyperkalemia) . Regional citrate anticoagulation is a good alternative to heparin use in hemodialysis for patients with increased bleeding risk , but its implementation in bicarbonate hemodialysis (BHD) is laborious and cumbersome: severe side effects can occur due to citrate metabolism and difficulties in adaptation of calcium infusion into the venous line .Therefore, the use of citrate as a dialysis buffer instead of acetate has proven a safe alternative to acetate-containing bicarbonate dialysis and on-line hemodiafiltration without significant hypocalcemia or clinically important coagulation issues.The aim of the present study is the comparison of the patency of the dialyzer ,the quality of life and blood parameters between pre and potdiltuiotn Ol-HDF with citrate dialysate (CD). No study to date has previously compared the use of citrate dialysate between these two modalities in oL-HDF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group interrupted times-series design (ITS)
| Arm | Type | Receives |
|---|---|---|
| Pre-dilution online hemodiafiltration | Experimental | Procedure: Pre-dilution online hemodiafiltration with citrate dialysate, Procedure: Post-dilution hemodiafiltration with citrate dialysateThe study was conducted for a 28-week period in two phases: For the first 12 weeks, all of the patients were subjected to CD with pre-dilution oL-HDF.After enrollment, all patients began a 2-week run-in period with conventional dialysis fluid containing acetate and the lowest dose of unfractionated heparin. The investigator titrated the heparin dose by reducing the dose step by step, 25% in each step, until the final minimal dose was achieved. The experimental study consisted of 3 phases, 4 weeks in each phase, and the phases were separated by 1-week washout periods. The second phase will run after finishing the first phase with the same protocol but with post-dilution online HDF.There will be 2 weeks washout period before starting this phase |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable condition
- Having been under HD for at least three months
- he vascular access should have blood flow ≥ 300 mL/min.
Key exclusion criteria (7 listed)
- no heparin use during HD
- refusal to participate,
- intolerance or allergy to citrate
- concurrent infection
- poor life expectancy due to metastatic cancer, severe cirrhosis and AIDS.
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 |
|---|---|---|
| Pre-dilution online hemodiafiltration with citrate dialysateAfter enrollment, all patients began a 2-week run-in period with conventional dialysis fluid containing acetate and the lowest dose of unfractionated heparin. The investigator titrated the heparin dose by reducing the dose step by step, 25% in each step, until the final minimal dose was achieved. The experimental study consisted of 3 phases, 4 weeks in each phase, and the phases were separated by 1-week washout periods. Phase 1 used CD with 50% of the heparin dose of the baseline. Phases 2 and 3 used 25% heparin and no heparin, respectively. New dialyzers were introduced at the beginning of each phase and the heparin dose was resumed during the washout phase. The calcium concentration in the dialysis fluid was kept constant (1.5 mmol/L) to allow evaluation of the effect of CD on calcium balance | Procedure or surgery | Pre-dilution online hemodiafiltration |
| Post-dilution hemodiafiltration with citrate dialysatesame protocol with post-dilution Ol-HDF in these same patients for the later 12 weeks. | Procedure or surgery | Pre-dilution online hemodiafiltration |
Primary outcome
clotting score between pre and post dilution online-hemodiafiltration
Time frame: 28 weeks
5 grades of clotting score, Grade 1;No or very little residual blood in the filters.Grade 1;Residual blood in less than 10% of the fibers. Grade 2; Residual blood 10-25%. Grade 3; Residual blood 25-50%.Grade 4 ,Residual blood > 50%
5 secondary outcomes
quality of life between pre and post dilution online-hemodiafiltration
Time frame: 28 weeks
adequacy of dialysis between pre and post dilution online-hemodiafiltration
Time frame: 28 weeks
calcium level between pre and post dilution online-hemodiafiltration
Time frame: 28 weeks
phosphorus level between pre and post dilution online-hemodiafiltration
Time frame: 28 weeks
intact parathyroid level between pre and post dilution online-hemodiafiltration
Time frame: 28 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 8 Feb 2023.
- Results publication: PubMed 29702860Thaweethamcharoen T, Srimongkol W, Noparatayaporn P, Jariyayothin P, Sukthinthai N, Aiyasanon N, Kitisriworapan P, Jantarakana K, Vasuvattakul S. Validity and Reliability of KDQOL-36 in Thai Kidney Disease Patient. Value Health Reg Issues. 2013 May;2(1):98-102. doi: 10.1016/j.vhri.2013.02.011. Epub 2013 Mar 26.
- Results publication: PubMed 9623523Canaud B, Bosc JY, Leray H, Stec F, Argiles A, Leblanc M, Mion C. On-line haemodiafiltration: state of the art. Nephrol Dial Transplant. 1998;13 Suppl 5:3-11. doi: 10.1093/ndt/13.suppl_5.3.
- Results publication: PubMed 16641921Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int. 2006 Jun;69(11):2087-93. doi: 10.1038/sj.ki.5000447.
- Results publication: PubMed 12703882Guth HJ, Gruska S, Kraatz G. On-line production of ultrapure substitution fluid reduces TNF-alpha- and IL-6 release in patients on hemodiafiltration therapy. Int J Artif Organs. 2003 Mar;26(3):181-7. doi: 10.1177/039139880302600301.
- Results publication: PubMed 11682665Canaud B, Wizemann V, Pizzarelli F, Greenwood R, Schultze G, Weber C, Falkenhagen D. Cellular interleukin-1 receptor antagonist production in patients receiving on-line haemodiafiltration therapy. Nephrol Dial Transplant. 2001 Nov;16(11):2181-7. doi: 10.1093/ndt/16.11.2181.
- Results publication: PubMed 16825330Carracedo J, Merino A, Nogueras S, Carretero D, Berdud I, Ramirez R, Tetta C, Rodriguez M, Martin-Malo A, Aljama P. On-line hemodiafiltration reduces the proinflammatory CD14+CD16+ monocyte-derived dendritic cells: A prospective, crossover study. J Am Soc Nephrol. 2006 Aug;17(8):2315-21. doi: 10.1681/ASN.2006020105. Epub 2006 Jul 6.
- Results publication: PubMed 11244190Lin CL, Yang CW, Chiang CC, Chang CT, Huang CC. Long-term on-line hemodiafiltration reduces predialysis beta-2-microglobulin levels in chronic hemodialysis patients. Blood Purif. 2001;19(3):301-7. doi: 10.1159/000046958.
- Results publication: PubMed 34128110Kurihara Y, Hosoya H, Kishihara R, Yoshinaga M, Iwadate Y, Yamauchi F, Saito T, Sakurai K. Comparison of the effects of pre-dilution and post-dilution online hemodiafiltration on the levels of inflammatory markers, lymphocytes, and platelets. J Artif Organs. 2022 Mar;25(1):59-65. doi: 10.1007/s10047-021-01281-5. Epub 2021 Jun 14.
- Results publication: PubMed 23466373Tsuchida K, Minakuchi J. Clinical benefits of predilution on-line hemodiafiltration. Blood Purif. 2013;35 Suppl 1:18-22. doi: 10.1159/000346221. Epub 2013 Feb 25.
- Results publication: PubMed 9684701Hottelart C, Achard JM, Moriniere P, Zoghbi F, Dieval J, Fournier A. Heparin-induced hyperkalemia in chronic hemodialysis patients: comparison of low molecular weight and unfractionated heparin. Artif Organs. 1998 Jul;22(7):614-7. doi: 10.1046/j.1525-1594.1998.06204.x.
- Results publication: PubMed 23306782Aniort J, Petitclerc T, Creput C. Safe use of citric acid-based dialysate and heparin removal in postdilution online hemodiafiltration. Blood Purif. 2012;34(3-4):336-43. doi: 10.1159/000345342. Epub 2013 Jan 9.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-dilution online hemodiafiltration with citrate dialysate and Post-dilution hemodiafiltration with citrate dialysate in people with Hemodiafiltration and Heparin, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital at 2 sites in Thailand.
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 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
clotting score between pre and post dilution online-hemodiafiltration (time frame: 28 weeks). 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 NCT05280106, which also lists 11 linked publications.
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 8 Feb 2023.