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Completed

NCT Number: NCT06505616

SOLFA Study to Explore the Thrombogenicity of a Dialyzer

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™.

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Key information

Conditions

End Stage Renal Disease on Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: four weeks, carried out in two phases

    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.

Secondary outcomes

  1. Effect of heparin reduction or discontinuation

    Time frame: four weeks, carried out in two phases

    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.

Sponsors and collaborators

Lead sponsor

Fundación Senefro

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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