Consensus Statement: Hemostasis Trial Outcomes in Cardiac Surgery and Mechanical Support

BACKGROUND Research evaluating hemostatic agents for the treatment of clinically significant bleeding has been hampered by inconsistency and lack of standardized primary clinical trial outcomes. Clinical trials of hemostatic agents in both cardiac surgery and mechanical circulatory support, such as extracorporeal membrane oxygenation and ven-tricular assist devices, are examples of studies that lack implementation of universally accepted outcomes. METHODS A subgroup of experts convened by the National Heart, Lung, and Blood Institute and the US Department of Defense developed consensus recommendations for primary outcomes in cardiac surgery and mechanical circulatory support. RESULTS For cardiac surgery the primary efficacy endpoint of total allogeneic blood products (units vs mL/kg for pe-diatric patients) administered intraoperatively and postoperatively through day 5 or hospital discharge is recommended. For mechanical circulatory support outside the perioperative period the recommended primary outcome for extracorporeal membrane oxygenation is a 5-point ordinal score of thrombosis and bleeding severity adapted from the Common Ter-minology Criteria for Adverse Events version 5.0. The recommended primary endpoint for ventricular assist device is freedom from disabling stroke (Common Terminology Criteria for Adverse Events AE double dagger grade 3) through day 180. CONCLUSIONS The proposed composite risk scores could impact the design of upcoming clinical trials and enable comparability of future investigations. Harmonizing and disseminating global consensus definitions and management guidelines can also reduce patient heterogeneity that would confound standardized primary outcomes in future research . (Ann Thorac Surg 2022;113:1026-35) 2022 by The Society of Thoracic Surgeons