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

Authors :
Philip C. Spinella
Marie E. Steiner
Jun Teruya
M. Patricia Massicotte
Ravi R. Thiagarajan
Christopher S. Almond
Ryan R. Davies
Lisa Baumann-Kreuziger
Jean M. Connors
Larry J. Dumont
Melania M. Bembea
Jerrold H. Levy
Keyvan Karkouti
Massimo Griselli
David Faraoni
Heidi J. Dalton
Source :
The Annals of Thoracic Surgery. 113:1026-1035
Publication Year :
2022
Publisher :
Elsevier BV, 2022.

Abstract

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.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.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.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.

Details

ISSN :
00034975
Volume :
113
Database :
OpenAIRE
Journal :
The Annals of Thoracic Surgery
Accession number :
edsair.doi.dedup.....8fb946d9745bed9731df4c33caac61cb
Full Text :
https://doi.org/10.1016/j.athoracsur.2021.09.080