SOLFA study: a multicenter, open-label, prospective, randomized study to investigate the clotting propensity of asymmetric cellulose triacetate membrane compared to synthetic membranes in on line HDF.

Abstract

Background: Performing hemodialysis without heparin is still challenging. The objective of the present work was to evaluate the impact on thrombogenicity of the hemodialysis circuit using synthetic membranes compared to the asymmetric cellulose triacetate (ATA) membrane.

Methods: Prospective, multicenter, randomized, crossover, open-label study. In each of the two phases of the study, six consecutive hemodialysis sessions were performed over two weeks, in which the patients were dialyzed with the dialyzer randomly assigned (synthetic vs asymmetric cellulose triacetate membrane). During the six sessions of both phases, the heparin dose was progressively reduced from the full usual heparin dose in the first session to zero heparin in the sixth session. After each session, visual inspection of the venous chamber and dialyzer was performed, and a coagulation score was assigned. A micro- computed tomography (CT) scanning of some dialyzers was also executed at Ghent University.

Results: Comparison of the last completed sessions shows that there were significant differences depending on the dialyzer used: 60% of dialysis sessions with asymmetric cellulose triacetate could be completed without heparin versus 24% with synthetic membranes (p = 0.01). We also found differences in the number of sessions completed: 46% with the asymmetric cellulose triacetate membrane and 7% with the synthetic membrane (p = 0.001). The results obtained with the micro-CT analysis were also better with the asymmetric cellulose triacetate.

Conclusions: Our findings strongly suggest that asymmetric cellulose triacetate membranes may be useful in situations in which dialysis should be performed without heparin or with low-dose heparins.

Trail registry: NCT06505616.