TY - JOUR
T1 - Consensus Statement
T2 - Hemostasis Trial Outcomes in Cardiac Surgery and Mechanical Support
AU - Levy, Jerrold H.
AU - Faraoni, David
AU - Almond, Christopher S.
AU - Baumann-Kreuziger, Lisa
AU - Bembea, Melania M.
AU - Connors, Jean M.
AU - Dalton, Heidi J.
AU - Davies, Ryan
AU - Dumont, Larry J.
AU - Griselli, Massimo
AU - Karkouti, Keyvan
AU - Massicotte, M. Patricia
AU - Teruya, Jun
AU - Thiagarajan, Ravi R.
AU - Spinella, Philip C.
AU - Steiner, Marie E.
N1 - Funding Information:
The authors acknowledge the participation, mentorship, and support provided by the late Dr M. Patricia Massicotte to this consensus article and for all her leadership and wisdom over the decades. Funding for the consensus work was provided by the National Institutes of Health and Department of Defense. Jean M. Connors received institutional research funding from CSL Behring. Larry J. Dumont received research funding from Cerus Corporation, Terumo BCT, and Sinopia. M. Patricia Massicotte participated in the National Heart, Lung, and Blood Institute PumpKIN study: VADs in infants and children a feasibility study.
Publisher Copyright:
© 2022 The Society of Thoracic Surgeons
PY - 2022/3
Y1 - 2022/3
N2 - 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 ventricular 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 pediatric 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 Terminology 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 ≥ 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.
AB - 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 ventricular 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 pediatric 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 Terminology 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 ≥ 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.
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U2 - 10.1016/j.athoracsur.2021.09.080
DO - 10.1016/j.athoracsur.2021.09.080
M3 - Review article
C2 - 34826386
AN - SCOPUS:85122933455
SN - 0003-4975
VL - 113
SP - 1026
EP - 1035
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 3
ER -