SOLFA Study to Explore the Thrombogenicity of a Dialyzer

July 10, 2024 updated by: Fundación Senefro

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™.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Asymmetric cellulose triacetate (ATA™) membrane (Solacea™, Nipro, Osaka, Japan)
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
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.
Active Comparator: Synthetic haemodialysers membranes
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four weeks, carried out in two phases

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four weeks, carried out in two phases

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Senefro

Investigators

  • Principal Investigator: Marta Puerta, MD, University Hospital Infanta Leonor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

May 20, 2023

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENEFRO SOLFA study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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