SOLFA Study to Explore the Thrombogenicity of a Dialyzer

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.