https://doi.org/10.1007/s00392-025-02625-4
1Universitätsklinikum Gießen und Marburg GmbH Klinik für Herz-, Kinderherz- und Gefäßchirurgie Gießen, Deutschland; 2Justus-Liebig-Universität Giessen Physiologisches Institut Gießen, Deutschland; 3Justus Liebig Universität Gießen Institut für Medizinische Statistik Gießen, Deutschland; 4UKGM Gießen Anaesthesiologie und operative Intensivmedizin Gießen, Deutschland
Background
ECLS-Patients can develop heparin (Hep)-induced-thrombocytopenia Type II (HITII). Approval for direct thrombin-antagonism in ECLS is lacking. Here we analyze if treatment of ECLS patients with direct thrombin antagoism is feasible and save.
Methods
“Urgent” or “emergency” ECLS patients (veno-arterial)/ECMO(veno-venous) were studied in a prospective all comers study . ICU morbidity, survival, therapeutic stability of anticoagulation, bleeding, thrombosis and technical integrity was controlled. Treatment with direct thrombin antagonism (DTA) was analyzed regarding non inferiority and superiority compared to anticoagulation with heparin by Poisson-Regression.
Results
We examined 254 ECMO patients from 2018 to 2020. 153 va-ECMO / 101 vv ECMO patients always received heparin (95/43), only DTA (8/6) or a switch (50/52) from heparin to DTA in cases of suspected heparin-induced thrombocytopenia and reduced platelet count (p =0.017). Hepatic function did not differ. Patients who underwent a change in anticoagulation showed increased infection levels before the change, but no reduction in GFR. Before switching from heparin to DTA, there was only a moderate increase in the INR, a decrease in the Quick and no therapeutic increase in the PTT with heparin in these patients. Patients after switching from heparin to DTA showed a clear superiority of DTA in terms of (A) overall complication rate (0.6479/0.7871/0.9546) (defined as bleeding from any cause, stroke, amputation, thrombosis and device-occlusion) and (B) the rate of bleeding (0.6432/0.7829/0.9513) and a NON inferiority in terms of preventing strokes. With regard to thrombosis and system occlusions, there is no difference
between heparin and DTA. DTA resulted in greater therapy stability and fewer running rate adjustments.
Conclusion
DTA is not inferior in ECLS/ECMO therapy in patients with proven or suspected HITII. In case of HIT II, thrombin-antagonism during ECLS/ECMO is save. Regarding all complications, incidence of stroke, thromboembolism and amputation DTA is furthermore superior.