SOLFA Study to Explore the Thrombogenicity of a Dialyzer

Fundación Senefro

Status: Completed

Conditions: End Stage Renal Disease on Dialysis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06505616

SENEFRO SOLFA study

Details and patient eligibility

About

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™.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

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

Synthetic haemodialysers membranes

Active Comparator group

Description:

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)

Treatment:

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