SOLFA Study to Explore the Thrombogenicity of a Dialyzer

NCT06505616 | Completed DMC

• 1 other identifier: SENEFRO SOLFA study
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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™.

Conditions

End Stage Renal Disease on Dialysis

Keywords

anticoagulation; heparin; biocompatibility; haemodialysis; haemodiafiltration; haemodialyser

Outcome Measures

Primary Outcomes (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.

  four weeks, carried out in two phases

Secondary Outcomes (1)

• Effect of heparin reduction or discontinuation

  four weeks, carried out in two phases

Study Arms (2)

Asymmetric cellulose triacetate (ATA™) membrane (Solacea™, Nipro, Osaka, Japan)

ACTIVE COMPARATOR

Patients were dialyzed with an asymmetric cellulose triacetate (ATA™) membrane (Solacea™, Nipro, Osaka, Japan). Non synthetic membrane, cellulose membrane.

Device: Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it

Synthetic haemodialysers membranes

ACTIVE COMPARATOR

Synthetic haemodialysis membranes habitual used in the hospitals included in the study: FXCorDiax 800™ (Fresenius MC),Polyflux 210H™ (Baxter),Revaclear 400™ (Baxter),Eliseo 19H™ (Nipro)

Device: Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it

Interventions

Compared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it DEVICE

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.

Asymmetric cellulose triacetate (ATA™) membrane (Solacea™, Nipro, Osaka, Japan); Synthetic haemodialysers membranes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Senefro: lead

Study Sites (1)

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Related Publications (12)

• 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.

  PMID: 33135208 RESULT

• 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.

  PMID: 21727925 RESULT

• 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.

  PMID: 25859371 RESULT

• 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.

  PMID: 24825343 RESULT

• 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.

  PMID: 38189095 RESULT

• 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.

  PMID: 25007166 RESULT

• 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.

  PMID: 18824874 RESULT

• 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.

  PMID: 23411788 RESULT

• 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.

  PMID: 37326323 RESULT

• 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.

  PMID: 19210277 RESULT

• 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.

  PMID: 33564444 RESULT

• 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.

  PMID: 39827429 DERIVED

Study Officials

• Marta Puerta, MD

  University Hospital Infanta Leonor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, multicenter, randomized, crossover, non-masked study

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: July 17, 2024
• Study Start: January 17, 2022
• Primary Completion: February 10, 2022
• Study Completion: May 20, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)