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End Stage Renal Disease on DialysisNCT06505616

SOLFA Study to Explore the Thrombogenicity of a Dialyzer

A study testing Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it in people with End Stage Renal Disease on Dialysis, run by Fundación Senefro at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, multicenter, randomized, crossover, non-masked study to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea™. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Renal Disease on Dialysis
What is being tested?
Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSpain
Study dates
17 Jan 2022to 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

  • Patients over 18 years of age.
  • Patients in a chronic haemodialysis program who had been on dialysis for more than three months were included.
  • Patients provided informed consent.

Who cannot join

  • allergies to synthetic membranes
  • allergies to heparin
  • patients receiving anticoagulant treatment
  • women Pregnant
  • breastfeeding
  • patients with cognitive impairment

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

Other trials in Spain

About this study

Official title: SOLFA Study: A Multicenter, Open-label, Prospective, Randomized Study to Explore the Clotting Propensity of Solacea™ Dialyser Comparing With Synthetic Membranes

Prospective, multicenter, randomized, crossover, non-masked study to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea™.

Read the detailed description

This is a prospective, multicenter, randomized, crossover, non-masked study that included 32 patients from 4 Spanish hospitals.

The objective of the present work is to evaluate the impact on the thrombogenicity of the haemodialysis circuit by comparing synthetic haemodialysers against the ATA membrane of the Solacea™.

Study population. Patients over 18 years of age in a chronic haemodialysis program who had been on dialysis for more than three months were included. All patients provided informed consent. The study was approved by the local Ethics Committee and was conducted according to the principles of the Declaration of Helsinki. The exclusion criteria were allergies to synthetic membranes and allergies to heparin, patients receiving anticoagulant treatment, women Pregnant, breastfeeding or patients with cognitive impairment.

In each of the two phases of six consecutive two-week HD sessions, patients were dialyzed according to their usual schedule with the haemodialyser assigned after randomization (synthetic vs ATA membrane). During the six sessions of both phases, the dose of heparin was progressively reduced, 100% usual heparin dose in the first session until sixth session without heparin.

After each session, carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score previously published. Dialyser score from 0 (completly clean, 0% coagulated fibers) to 4 (100% coagulated fibers). Venous chamber score from 0 (clean, without clotting) to 3 (complete oclusión, dialysis is not possible).

Demographic data and dialysis parameters were also collected. The dialyzers from 8 patients were collected at the beginning and end of each study arm and scanned with a reference non-invasive micro-CT (Computed Tomography) scanning technique.

Being tested
Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it
Keywords
anticoagulation, heparin, biocompatibility, haemodialysis, haemodiafiltration, haemodialyser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing itDevice

    The duration of the study was four weeks, carried out in two phases. After screening, patients were randomized to be dialyzed with the Solacea™ hemodialyzer versus the usual hemodialyzer, which in all cases had to be a synthetic membrane. In both arms, heparin was progressively decreased until it was discontinued. Afterwards the patients were crossed over to the other arm.

Study groups in NCT06505616
Study groupRoleWhat they receive
Asymmetric cellulose triacetate (ATA™) membrane (Solacea™, Nipro, Osaka, Japan)Active comparatorPatients were dialyzed with an asymmetric cellulose triacetate (ATA™) membrane (Solacea™, Nipro, Osaka, Japan). Non synthetic membrane, cellulose membrane.
Receives: Device: Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it
Synthetic haemodialysers membranesActive comparatorSynthetic haemodialysis membranes habitual used in the hospitals included in the study: FXCorDiax 800™ (Fresenius MC),Polyflux 210H™ (Baxter),Revaclear 400™ (Baxter),Eliseo 19H™ (Nipro)
Receives: Device: Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact on the thrombogenicity of the haemodialysis circuit by comparing dialyzers

    The investigators measure the impact of Solacea membrane on the thrombogenicity of the haemodialysis circuit compared to other high-permeability synthetic dialysers commonly used in clinical practice.

    Heparin was progressively reduced until it was discontinued. After each session, investigators carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score. In 8 patients also a scanning technique was carried out.

    Measured: four weeks, carried out in two phases

Secondary outcomes (1)

  1. Effect of heparin reduction or discontinuation

    The investigators measure the effect of heparin reduction or discontinuation on vascular access haemostasis time, on dialysis efficacy by measuring KT, on percentage reduction of molecules such as myoglobin or β2-microglobulin, and in the amount of convective volume in patients in OL HDF. During the six sessions of both phases, the dose of heparin was progressively reduced until the last session without heparin. After each session, carried out a visual inspection of the venous chamber and the haemodialyser and assigned a coagulation score. In 8 patients also a scanning technique was carried out.

    Measured: four weeks, carried out in two phases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study start17 Jan 2022
  3. Primary completion10 Feb 2022
  4. Study completion20 May 2023

Resources

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
Model description
prospective, multicenter, randomized, crossover, non-masked study
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06505616
Sponsor's protocol ID
SENEFRO SOLFA study
Status last verified
Jul 2024
First submitted
5 Jun 2024
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Claudel SE, Miles LA, Murea M. Anticoagulation in hemodialysis: A narrative review. Semin Dial. 2021 Mar;34(2):103-115. doi: 10.1111/sdi.12932. Epub 2020 Nov 1.

    PubMed 33135208

  • Davenport A. What are the anticoagulation options for intermittent hemodialysis? Nat Rev Nephrol. 2011 Jul 5;7(9):499-508. doi: 10.1038/nrneph.2011.88.

    PubMed 21727925

  • Sahota S, Rodby R. Inpatient hemodialysis without anticoagulation in adults. Clin Kidney J. 2014 Dec;7(6):552-6. doi: 10.1093/ckj/sfu114. Epub 2014 Oct 30.

    PubMed 25859371

  • Guery B, Alberti C, Servais A, Harrami E, Bererhi L, Zins B, Touam M, Joly D. Hemodialysis without systemic anticoagulation: a prospective randomized trial to evaluate 3 strategies in patients at risk of bleeding. PLoS One. 2014 May 13;9(5):e97187. doi: 10.1371/journal.pone.0097187. eCollection 2014.

    PubMed 24825343

  • Nakornchai P, Jitraree A, Homjan MC, Laykhram T, Trakarnvanich T. Comparison of citrate dialysate in pre- and post-dilution online hemodiafiltration: effect on clot formation and adequacy of dialysis in hemodialysis patients. Ren Fail. 2024 Dec;46(1):2302109. doi: 10.1080/0886022X.2024.2302109. Epub 2024 Jan 8.

    PubMed 38189095

  • Laville M, Dorval M, Fort Ros J, Fay R, Cridlig J, Nortier JL, Juillard L, Debska-Slizien A, Fernandez Lorente L, Thibaudin D, Franssen C, Schulz M, Moureau F, Loughraieb N, Rossignol P. Results of the HepZero study comparing heparin-grafted membrane and standard care show that heparin-grafted dialyzer is safe and easy to use for heparin-free dialysis. Kidney Int. 2014 Dec;86(6):1260-7. doi: 10.1038/ki.2014.225. Epub 2014 Jul 9.

    PubMed 25007166

  • Bramham K, Varrier M, Asgari E, Makanjuola D. Comparison of Tinzaparin and unfractionated heparin as anticoagulation on haemodialysis: equal safety, efficacy and economical parity. Nephron Clin Pract. 2008;110(2):c107-13. doi: 10.1159/000158561. Epub 2008 Sep 30.

    PubMed 18824874

  • Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.

    PubMed 23411788

  • Blankestijn PJ, Vernooij RWM, Hockham C, Strippoli GFM, Canaud B, Hegbrant J, Barth C, Covic A, Cromm K, Cucui A, Davenport A, Rose M, Torok M, Woodward M, Bots ML; CONVINCE Scientific Committee Investigators. Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure. N Engl J Med. 2023 Aug 24;389(8):700-709. doi: 10.1056/NEJMoa2304820. Epub 2023 Jun 16.

    PubMed 37326323

  • Sombolos KI, Fragia TK, Gionanlis LC, Veneti PE, Bamichas GI, Fragidis SK, Georgoulis IE, Natse TA. The anticoagulant activity of enoxaparin sodium during on-line hemodiafiltration and conventional hemodialysis. Hemodial Int. 2009 Jan;13(1):43-7. doi: 10.1111/j.1542-4758.2009.00336.x.

    PubMed 19210277

  • Vanommeslaeghe F, Josipovic I, Boone M, Dhondt A, Van Biesen W, Eloot S. A randomized cross-over study with objective quantification of the performance of an asymmetric triacetate and a polysulfone dialysis membrane using different anticoagulation strategies. Clin Kidney J. 2019 Dec 22;14(1):398-407. doi: 10.1093/ckj/sfz163. eCollection 2021 Jan.

    PubMed 33564444

  • Puerta M, Jaldo MT, Munoz P, Martinez-Miguel P, Maduell F, Lancho C, Garcia-Herrera AL, Eloot S, de Sequera P. SOLFA study: a multicenter, open-label, prospective, randomized study to investigate the clotting propensity of asymmetric cellulose triacetate membrane compared to synthetic membranes in on line HDF. J Nephrol. 2025 Mar;38(2):697-705. doi: 10.1007/s40620-024-02197-y. Epub 2025 Jan 19.

    PubMed 39827429

Questions about this trial

What is this clinical trial studying?

A study testing Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it in people with End Stage Renal Disease on Dialysis, run by Fundación Senefro at 1 site in Spain.

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 6 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 17 Jul 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 Spain. 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?

Impact on the thrombogenicity of the haemodialysis circuit by comparing dialyzers (time frame: four weeks, carried out in two phases). 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 NCT06505616, which also lists 12 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 17 Jul 2024.

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