TY - JOUR
T1 - Comparison of ROTEM® Delta and ROTEM® Sigma transfusion algorithm performance in thoracic aortic surgery
T2 - a single-centre prospective observational cohort study
AU - van Haeren, Maite M.T.
AU - Breel, Jenni S.
AU - Schenk, Jimmy
AU - Eberl, Susanne
AU - Hamer, Henrike M.
AU - Hollmann, Markus W.
AU - Vlaar, Alexander P.J.
AU - Müller, Marcella
AU - Hermanns, Henning
AU - Meesters, Michael
AU - Viersen, Victor
AU - Spanjersberg, Sander
AU - Horst, Maarten ter
AU - Fenger-Eriksen, Christian
AU - Hermanns, Henning
AU - Müller, Marcella
AU - Heymann, Christian von
AU - Schoechl, Herbert
N1 - © 2024 The Author(s)
PY - 2025/2
Y1 - 2025/2
N2 - BackgroundThromboelastometry plays a key role in many transfusion algorithms. ROTEM® Sigma is the fully automated successor of ROTEM® Delta. Compatibility with current ROTEM® Delta-based algorithms remains uncertain. This study compares ROTEM® Delta with ROTEM® Sigma in patients undergoing thoracic aortic surgery.MethodsThree ROTEM® measurements in duplicate (one Delta and one Sigma) per patient were performed during aortic surgery. The primary outcome was the percentage of patients who would have received a different haemostatic intervention after protamine reversal based on the institutional ROTEM®-guided transfusion algorithm (‘deviation’). A 10% deviation was deemed acceptable. Secondary outcomes were differences in numerical values assessed by Passing–Bablok regressions, Bland–Altman plots, and correlations with conventional coagulation tests.ResultsOf 111 patients, 102 had matched post-protamine ROTEM® measurements. There were 43 algorithm deviations. Most deviations (29) were attributable to conflicting advice on CT EXTEM-based plasma or prothrombin complex concentrate (PCC) administration; in 25 patients, Delta results advised the administration of plasma or PCC, whereas Sigma did not, and vice versa in four patients. Deviations on additional protamine, fibrinogen concentrate, or platelet administration were acceptable. All numerical ROTEM® variables examined passed the criteria for equivalence, except for A10 FIBTEM at baseline and A10 EXTEM in heparinised and post-protamine samples, which would not have led to clinical consequences. Correlations with conventional coagulation tests were similar or better for Sigma compared with Delta.ConclusionsROTEM® Sigma can be used with existing ROTEM-guided transfusion algorithms in cardiothoracic surgery except for the advice for administration of plasma or PCC.Clinical Trial RegistrationNetherlands trial register NL8273.
AB - BackgroundThromboelastometry plays a key role in many transfusion algorithms. ROTEM® Sigma is the fully automated successor of ROTEM® Delta. Compatibility with current ROTEM® Delta-based algorithms remains uncertain. This study compares ROTEM® Delta with ROTEM® Sigma in patients undergoing thoracic aortic surgery.MethodsThree ROTEM® measurements in duplicate (one Delta and one Sigma) per patient were performed during aortic surgery. The primary outcome was the percentage of patients who would have received a different haemostatic intervention after protamine reversal based on the institutional ROTEM®-guided transfusion algorithm (‘deviation’). A 10% deviation was deemed acceptable. Secondary outcomes were differences in numerical values assessed by Passing–Bablok regressions, Bland–Altman plots, and correlations with conventional coagulation tests.ResultsOf 111 patients, 102 had matched post-protamine ROTEM® measurements. There were 43 algorithm deviations. Most deviations (29) were attributable to conflicting advice on CT EXTEM-based plasma or prothrombin complex concentrate (PCC) administration; in 25 patients, Delta results advised the administration of plasma or PCC, whereas Sigma did not, and vice versa in four patients. Deviations on additional protamine, fibrinogen concentrate, or platelet administration were acceptable. All numerical ROTEM® variables examined passed the criteria for equivalence, except for A10 FIBTEM at baseline and A10 EXTEM in heparinised and post-protamine samples, which would not have led to clinical consequences. Correlations with conventional coagulation tests were similar or better for Sigma compared with Delta.ConclusionsROTEM® Sigma can be used with existing ROTEM-guided transfusion algorithms in cardiothoracic surgery except for the advice for administration of plasma or PCC.Clinical Trial RegistrationNetherlands trial register NL8273.
UR - https://www.scopus.com/pages/publications/85210918118
U2 - 10.1016/j.bja.2024.09.028
DO - 10.1016/j.bja.2024.09.028
M3 - Article
C2 - 39627120
AN - SCOPUS:85210918118
SN - 0007-0912
VL - 134
SP - 317
EP - 327
JO - British Journal of Anaesthesia
JF - British Journal of Anaesthesia
IS - 2
ER -