NCT06505616

SOLFA Study to Explore the Thrombogenicity of a Dialyzer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Fundación Senefro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease on Dialysis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-02-10
• Completion: 2023-05-20
• First posted: 2024-07-17
• Last updated: 2024-07-17

Locations

1 site across 1 country: Spain