Risk Reduction by Direct Thrombin Antagonism during ECMO Therapy

Background: ECLS patients can develop heparin (Hep)-induced thrombocytopenia Type II (HIT II). Approval for direct thrombin antagonism in ECLS is lacking. Here we analyze if treatment of ECLS patients with direct thrombin antagonism is feasible and safe.

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 were controlled. Treatment with direct thrombin antagonism (DTA) was analyzed regarding non-inferiority and superiority compared with 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 HIT II. In case of HIT II, thrombin antagonism during ECLS/ECMO is safe. Regarding all complications, incidence of stroke, thromboembolism, and amputation, DTA is furthermore superior.

Publication History

Article published online:
11 February 2025