Key result
In an ex vivo ECMO model, IMB-F12 resulted in higher activated clotting time (P=0.008) and better preserved collagen- and TRAP-induced platelet aggregation (P=0.004 and 0.005) compared to heparin.
Why the study?
Heparin is standard anticoagulation during ECMO, but thrombosis and bleeding remain prevalent complications, making selective FXIIa inhibitors a potential alternative.
Does IMB-F12 improve preservation of hemostasis compared to heparin in an ex vivo ECMO model using human blood?
RCT (n=10)
randomly allocated
Does IMB-F12 improve preservation of hemostasis compared to heparin in an ex vivo ECMO model using human blood?
p-value: p=0.008
In an ex vivo ECMO model, the FXIIa inhibitor IMB-F12 provided effective anticoagulation with better preservation of platelet aggregation compared to standard heparin.
FXIIa inhibition preserves platelet function better than heparin ex vivo; leaves open clinical translation in ECMO patients.
High Resolution Image Download MS PowerPoint Slide Extracorporeal membrane oxygenation (ECMO) is a form of life support for critically ill patients with severe respiratory or cardiac failure. Interactions between patient blood and ECMO biomaterials increase the risk of thrombosis, necessitating concurrent anticoagulation treatment, with the standard of care being heparin. However, hemostatic complications such as thrombosis and bleeding remain prevalent. Activated factor XII (FXIIa) inhibitors are selective anticoagulants and offer a potential alternative to heparin. We aimed to evaluate the efficacy of IMB-F12, a cyclotide-based FXIIa inhibitor, in human blood using an ex vivo ECMO model. Ten circuits were randomly allocated to heparin or IMB-F12 and ran for 6 h. Primary hemostasis was assessed by full blood cell count, aggregometry, flow cytometry, and von Willebrand factor multimer analysis; secondary hemostasis by activated clotting time (ACT), rotational thromboelastometry (ROTEM), prothrombin time, and activated partial thromboplastin time. All circuits ran successfully for 6 h with stable oxygenator resistance (pressure drop, flow). ACT was higher in the IMB-F12 group than in the heparin group ( p = 0.008). Significant differences were observed between ROTEM INTEM and HEPTEM in both IMB-F12 (clotting time (CT) p = 0.001, clot formation time (CFT) = 0.0004, maximum clot firmness (MCF) p = 0.03) and heparin (CT p = 0.01, CFT = 0.004, MCF p = 0.02) groups. Collagen- and thrombin receptor activating peptide (TRAP)-induced platelet aggregation were better preserved in the IMB-F12 group ( p = 0.004 and 0.005, respectively). In conclusion, IMB-F12 provides an effective alternative to heparin anticoagulation with an improved preservation of collagen- and TRAP-induced platelet aggregation in an ex vivo model.
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Gandini et al. (2025) conducted an RCT in Extracorporeal membrane oxygenation (ECMO) (n=10). IMB-F12 vs. Heparin was evaluated on Primary and secondary hemostasis (including activated clotting time, ROTEM, and platelet aggregation) (p=0.008). In an ex vivo ECMO model, IMB-F12 resulted in higher activated clotting time (P=0.008) and better preserved collagen- and TRAP-induced platelet aggregation (P=0.004 and 0.005) compared to heparin.
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