Evidence map›Paper›PMID 39827429›Full record

Trial reportJournal of nephrology2025

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.

Marta Puerta, María Teresa Jaldo, Patricia Muñoz, Patricia Martínez-Miguel, Francisco Maduell, Carolina Lancho, Antonio Luis García-Herrera, Sunny Eloot, Patricia de Sequera

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Journal of nephrology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06505616 (SOLFA Study), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06505616 nacompletednot on this map

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

TypeinterventionalSponsorFundación SenefroRan2022 to 2023Enrolled32ConditionsEnd Stage Renal Disease on DialysisArmsCompared the trombogenicity of the Solacea dialyzer with synthetic dialyzers after progressively decreasing heparin until discontinuing it
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Marta PuertaDepartment of Nephrology, University Hospital Infanta Leonor, Madrid, Spain.
María Teresa JaldoDepartment of Nephrology, University Hospital Infanta Leonor, Madrid, Spain.
Patricia MuñozDepartment of Nephrology, University Hospital Infanta Leonor, Madrid, Spain.
Patricia Martínez-MiguelDepartment of Nephrology, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
Francisco MaduellDepartment of Nephrology, Hospital Clinic, Barcelona, Spain.ORCID http://orcid.org/0000-0002-1673-0353
Carolina LanchoDepartment of Nephrology, Hospital Puerto Real, Cádiz, Spain.
Antonio Luis García-HerreraDepartment of Nephrology, Hospital Puerto Real, Cádiz, Spain.
Sunny ElootDepartment of Nephrology, Ghent University Hospital, Ghent, Belgium.ORCID http://orcid.org/0000-0002-6984-1743
Patricia de SequeraDepartment of Nephrology, University Hospital Infanta Leonor, Madrid, Spain. patricia.desequera@salud.madrid.org.ORCID http://orcid.org/0000-0001-7705-9228

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPerforming hemodialysis without heparin is still challenging. The objective of the present work was to evaluate the impact on thrombogenicity of the hemodialysis circuit using synthetic membranes compared to the asymmetric cellulose triacetate (ATA) membrane.

methodsProspective, multicenter, randomized, crossover, open-label study. In each of the two phases of the study, six consecutive hemodialysis sessions were performed over two weeks, in which the patients were dialyzed with the dialyzer randomly assigned (synthetic vs asymmetric cellulose triacetate membrane). During the six sessions of both phases, the heparin dose was progressively reduced from the full usual heparin dose in the first session to zero heparin in the sixth session. After each session, visual inspection of the venous chamber and dialyzer was performed, and a coagulation score was assigned. A micro- computed tomography (CT) scanning of some dialyzers was also executed at Ghent University.

resultsComparison of the last completed sessions shows that there were significant differences depending on the dialyzer used: 60% of dialysis sessions with asymmetric cellulose triacetate could be completed without heparin versus 24% with synthetic membranes (p = 0.01). We also found differences in the number of sessions completed: 46% with the asymmetric cellulose triacetate membrane and 7% with the synthetic membrane (p = 0.001). The results obtained with the micro-CT analysis were also better with the asymmetric cellulose triacetate.

conclusionsOur findings strongly suggest that asymmetric cellulose triacetate membranes may be useful in situations in which dialysis should be performed without heparin or with low-dose heparins. TRAIL REGISTRY: NCT06505616.

Indexed as

Blood CoagulationCelluloseMembranes, ArtificialRenal DialysisThrombosisAdultAgedAnticoagulantsCross-Over StudiesFemaleHeparinHumansMaleMiddle AgedProspective StudiesAnticoagulantsCellulosecellulose triacetateHeparinMembranes, ArtificialAnticoagulationBiocompatibilityHemodialysisHeparin

Identifiers

PMID39827429
PMCPMC11961484

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.