. 2021 Apr 16;10(8):1740. doi: 10.3390/jcm10081740

Table 6.

Main findings of studies reporting results from the HEPTEM assay (ROTEM).

First Author (Country)	Design	n	Ward	Device	Controls	INTEM						HEPTEM					Conclusions of the Study	Association with the Occurrence of Thrombotic Events	Definition of Hypercoagulability Assessed by VET According to the Authors
First Author (Country)	Design	n	Ward	Device	Controls	CT (s)	CFT (s)	α Angle (°)	A(x) (mm)	MCF (mm)	ML (%)	CT (s)	CFT (s)	α Angle (°)	MCF (mm)	ML (%)	Conclusions of the Study	Association with the Occurrence of Thrombotic Events
Iwasaki et al. (Japan) [26]	Case report	1	ICU (T1: D0)	NS	Reference range as assessed by the manufacturer	N	N	NP	↑	↑	NP	NP	NP	NP	NP	NP	Hypercoagulable state not detected by conventional coagulation tests	NA	Increased MCF and decreased CFT
			ICU (T2: D1)			N	N	NP	↑	↑	NP	N	N	NP	N	NP
			ICU (T3: D2)			N	N	NP	↑	↑	NP	N	N	NP	N	NP
Almskog et al. (Sweden) [41]	Prospective observational study	20	ICU	ROTEM sigma	Reference range previously established in healthy adults	↑	↓	NP	↑ ⁴	↑ ³	NP	↑	NP	NP	NP	NP	Association between MCF-FIBTEM and Clauss fibrinogen. Hypercoagulable state as assessed by ROTEM can be seen early after admission, with a more pronounced pattern in patients with increased disease severity: ROTEM useful to predict TE and care level?	NA	Increased MCF
Almskog et al. (Sweden) [41]	Prospective observational study	40	IMW	ROTEM sigma	Reference range previously established in healthy adults	↑	N	NP	↑	↑	NP	↑	NP	NP	NP	NP		NA	Increased MCF
Kruse et al. (Germany) [44]	Prospective observational study	40	ICU	ROTEM sigma	Reference range as assessed by the manufacturer	↑	↓	NP	NP	↑	↓	N	↓	NP	↑	NP	Hypercoagulable state with increased MCF related to high fibrinogen levels. Hypofibrinolysis with decreased ML%. Combination of ML% with D-dimers levels revealed high sensitivity and specificity of TE risk prediction	Yes	NP
		23/40	≥1 TE			↑	↓	NP	NP	↑	↓	N	↓	NP	↑	NP
		17/40	no TE			↑	↓	NP	NP	↑	N	N	↓	NP	↑	NP
Lazar et al. (USA) [50]	Case report	1	IMW	ROTEM sigma	Local reference range	N	N	N	↑	↑	N	N	N	N	↑	N	Hypercoagulable state present early in the clinical course of the disease	NA	Increased MCF
Lazar et al. (USA) [50]	Case report	1	IMW	ROTEM sigma	Local reference range	↑	N	N	N	N	N	N	N	N	N	N		NA	Increased MCF

Abbreviations: ICU: Intensive care unit (adults); IMW: Internal medicine ward; TE: Thrombotic events; N: Result within the reference range; ↑: Result above the reference range; ↓: Result below the reference range; NP: Not provided; NA: Not assessed; tPA: tissue plasminogen activator.