Clinical trial NCT06505616: SOLFA Study to Explore the Thrombogenicity of a Dialyzer
Official title: SOLFA Study: A Multicenter, Open-label, Prospective, Randomized Study to Explore the Clotting Propensity of Solacea™ Dialyser Comparing With Synthetic Membranes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: anticoagulation
heparin
biocompatibility
haemodialysis
haemodiafiltration
haemodialyser
Lead sponsor: Fundación Senefro
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective, multicenter, randomized, crossover, non-masked study
Primary purpose: TREATMENT

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™.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact on the thrombogenicity of the haemodialysis circuit by comparing dialyzers
timeFrame: four weeks, carried out in two phases
Secondary outcomes:
measure: Effect of heparin reduction or discontinuation
timeFrame: four weeks, carried out in two phases
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
affiliation: University Hospital Infanta Leonor
name: Marta Puerta, MD
role: PRINCIPAL_INVESTIGATOR
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