Testing the Hemocompatibility of a Novel Silicon-Coated Gas Exchanger: An In Vitro Study Using Human Blood

Background Gas exchangers are crucial devices that facilitate oxygen and carbon dioxide exchange, mimicking the lungs. They are vital components of Extracorporeal Membrane Oxygenation (ECMO) and cardiopulmonary bypass machines used in open-heart surgeries. Another application is the artificial lung (AL), aiming at endurable lung function replacement, e.g., as an alternative to lung transplantation. Despite over 50 years of use, gas exchanger modules remain expensive, limiting availability. This study presents a model to evaluate the hemocompatibility of a low-cost gas-exchanger using dialysis hollow fibers coated with silicone [1].

Methods & Materials Both the new gas exchanger as the native dialysator were integrated into identical in vitro test circuits, each filled with 75 mL heparinized (2IE/mL) human blood of the same donor. In each experiment, we kept an equal flow rate for six hours. Samples were taken and analyzed at regular intervals. The analytes measured included markers of hemolysis, coagulation activation, platelet count and activation, as well as markers of inflammation.

Results Bedside diagnostics showed non-inferiority of the new gas exchanger regarding hemolysis (K+-concentration at experiment end: 2.85 mmol/L in the silicon-coated module vs. 2.65 mmol/L in the native dialyzer). Coagulation parameters were also comparable (activated-clotting time (ACT) and platelet count at experiment end: 393 sec, 65.5 10³/µL in the silicon-coated module vs. 257 sec, 69.0 10³/µL in the native dialyzer). Further in-depth analyses of free hemoglobin (fHb), thrombin-antithrombin complexes (TAT), MPO, IL-6, C3, and C5a support these initial findings.

Conclusion In this in vitro, human-blood based study, we show that our new-designed gas exchanger module has a similar hemocompatibility then a commercial-available dialysator. This is an important step in creating a more biocompatible and more affordable and thus more available gas exchanger, which could help more patients benefit from this life-saving technology. Ultimately, long-term clinical applicability ought to be determined over in-vivo animal investigations.

Publikationsverlauf

Artikel online veröffentlicht:
25. August 2025

• Literatur

• 1 Mouzakis FL, Kashefi A, Spillner J, Rütten S, Mottaghy K, Hima F.. A new approach towards extracorporeal gas exchange and first in vitro results. Biomed Tech (Berl) 2023; 69: 257-263