Target for Anticoagulation in the Management of Venoarterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock: Rationale and Design for a Pilot Randomized Controlled Trial

Background: Bleeding and thromboembolic complications are significant challenges in the treatment of patients with cardiogenic shock (CS) who require venoarterial extracorporeal membrane oxygenation (VA-ECMO). Anticoagulation strategies that target higher activated partial thromboplastin time (aPTT) may exacerbate bleeding and lead to poor outcomes. However, there is a lack of sufficient randomized trials to determine the optimal aPTT target for this patient population. Research Question: Does anticoagulation management with a lower aPTT target range improve outcomes compared with a higher aPTT target range in patients with CS who are treated with VA-ECMO? Study Design and Methods: The Target for Anticoagulation in the Management of Venoarterial Extracorporeal Membrane Oxygenation for Cardiogenic Shock (TARGET-ECMO) trial is a multicenter, randomized controlled trial designed to evaluate the impact of different aPTT target ranges on outcomes in patients with CS who are treated with VA-ECMO. Patients are randomized into 1 of 2 groups: a lower aPTT target group (aPTT, 1.5 to1.8 times) or a higher aPTT target group (aPTT, 2.2 to 2.5 times). Results: The primary end point is a hierarchic composite outcome assessed at 7 days that consists of (1) death from any cause, (2) major bleeding, (3) thromboembolic events, and (4) total transfusion of RBC concentrates, which are evaluated with the use of a win ratio. Interpretation: Anticoagulation targets in VA-ECMO management typically are determined at the discretion of individual centers and clinicians. The Target for Anticoagulation in the Management of Venoarterial Extracorporeal Membrane Oxygenation for CS trial aims to improve the prognosis of patients with CS who are treated with VA-ECMO by exploring optimal aPTT target range for anticoagulation management. Clinical Trial Registration: Certified Review Board of Nagoya University Hospital (approval number: 2024-0166) and the Japan Registry of Clinical Trials (jRCT1041240069).