Validity, regulatory registration and approval of ROTEM thromboelastometry

Ebinger, T.; Ruland, An; Lakner, Meret; Schwaiger, Manfred

doi:10.1097/mbc.0b013e3283306e28

Cited by 15 publications

(10 citation statements)

References 14 publications

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“…ROTEM technology has the advantage of quickly providing a global assessment of coagulopathy, compared with the routine coagulation tests 26,27,28,29. As our results indicate, no significant differences could be noted in the assessed ROTEM parameters among the groups despite sporadic deterioration of the coagulation system after CPB.…”

Section: Discussionmentioning

confidence: 58%

Effect of 6% Hydroxyethyl Starch 130/0.4 as a Priming Solution on Coagulation and Inflammation Following Complex Heart Surgery

et al. 2014

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PurposeProlonged duration of cardiopulmonary bypass aggravates the degree of inflammation and coagulopathy. We investigated the influence of 6% hydroxyethyl starch (HES) 130/0.4 on coagulation and inflammation compared with albumin when used for both cardiopulmonary bypass priming and perioperative fluid therapy in patients undergoing complex valvular heart surgery.Materials and MethodsFifty four patients were randomly allocated into albumin-HES, albumin-nonHES, and HES-HES groups. The cardiopulmonary bypass circuit was primed with 5% albumin in the albumin-HES and albumin-nonHES group, and with HES in the HES-HES group. As perioperative fluid, only plasmalyte was used in the albumin-nonHES group whereas HES was used up to 20 mL/kg in the albumin-HES and albumin-HES group. Serial assessments of coagulation profiles using the rotational thromboelastometry and inflammatory markers (tissue necrosis factor-α, interleukin-6, and interleukin-8) were performed.ResultsPatients' characteristics and the duration of cardiopulmonary bypass (albumin-HES; 137±34 min, HES-HES; 136±47 min, albumin-nonHES; 132±39 min) were all similar among the groups. Postoperative coagulation profiles demonstrated sporadic increases in clot formation time and coagulation time, without any differences in the actual amount of perioperative bleeding and transfusion requirements among the groups. Also, inflammatory markers showed significant activation after cardiopulmonary bypass without any differences among the groups.ConclusionEven in the presence of prolonged duration of cardiopulmonary bypass, HES seemed to yield similar influence on the ensuing coagulopathy and inflammatory response when used for priming and perioperative fluid therapy following complex valvular heart surgery compared with conventional fluid regimen including albumin and plasmalyte.

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Section: Discussionmentioning

confidence: 58%

Effect of 6% Hydroxyethyl Starch 130/0.4 as a Priming Solution on Coagulation and Inflammation Following Complex Heart Surgery

et al. 2014

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“…Thromboelastometry is a point-of-care method capable of determining the kinetics of clot formation and clot lysis in whole-blood samples, thereby assessing the viscoelastic properties of the clot [12]. The clotting variables obtained by thromboelastometry include the clotting time, representing the time to onset of coagulation, the clot-formation time and alpha angle, both of which describe the kinetics of clot formation, and the maximum clot firmness, describing the mechanical properties of the clot, which depends on both platelet count and fibrin polymerization.…”

Section: Discussionmentioning

confidence: 99%

Comparison of thromboelastometry with procalcitonin, interleukin 6, and C-reactive protein as diagnostic tests for severe sepsis in critically ill adults

et al. 2010

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IntroductionEstablished biomarkers for the diagnosis of sepsis are procalcitonin, interleukin 6, and C-reactive protein. Although sepsis evokes changes of coagulation and fibrinolysis, it is unknown whether thromboelastometry can detect these alterations. We investigated whether thromboelastometry variables are suitable as biomarkers for severe sepsis in critically ill adults.MethodsIn the observational cohort study, blood samples were obtained from patients on the day of diagnosis of severe sepsis (n = 56) and from postoperative patients (n = 52), and clotting time, clot formation time, maximum clot firmness, alpha angle, and lysis index were measured with thromboelastometry. In addition, procalcitonin, interleukin 6, and C-reactive protein levels were determined. For comparison of biomarkers, receiver operating characteristic (ROC) curves were used, and the optimal cut-offs and odds ratios were calculated.ResultsIn comparison with postoperative controls, patients with sepsis showed an increase in lysis index (97% ± 0.3 versus 92 ± 0.5; P < 0.001; mean and SEM) and procalcitonin (2.5 ng/ml ± 0.5 versus 30.6 ± 8.7; P < 0.001). Clot-formation time, alpha angle, maximum clot firmness, as well as interleukin 6 and C-reactive protein concentrations were not different between groups; clotting time was slightly prolonged. ROC analysis demonstrated an area under the curve (AUC) of 0.901 (CI 0.838 - 0.964) for the lysis index, and 0.756 (CI 0.666 - 0.846) for procalcitonin. The calculated cut-off for the lysis index was > 96.5%, resulting in a sensitivity of 84.2%, and a specificity of 94.2%, with an odds ratio of 85.3 (CI 21.7 - 334.5).ConclusionsThe thromboelastometry lysis index proved to be a more reliable biomarker of severe sepsis in critically ill adults than were procalcitonin, interleukin 6, and C-reactive protein. The results also demonstrate that early involvement of the hemostatic system is a common event in severe sepsis.

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“…TEM using the ROTEM device was performed (Tem International GmbH, Munich, Germany). The method measures the viscoelastic properties of the clot and provides information on the speed of coagulation initiation, kinetics of clot growth, clot strength and breakdown . After blood is collected in a citrated tube (BD Vacutainer 9NC 0.129M; BD Diagnostics Preanalytical Systems, New Jersey, USA), the analyses are performed by pipetting 300 μl citrated whole blood and 20 μl 0·2 m calcium chloride with specific activators into a plastic cup.…”

Section: Methodsmentioning

confidence: 99%

“…Two more parameters are displayed in ROTEM assay: clot formation time (CFT (seconds); subsequent period until an amplitude of 20 mm is reached), and alpha angle (grades) given by the angle between the centre line and a tangent to the curve through the 2‐mm amplitude point. To achieve a proof of concept, we chose CT and MCF because they are the less variability parameters . Moreover, CT and MCF reflect different parts of haemostatic process: time to clot initiation and clot firmness, respectively.…”

Section: Methodsmentioning

confidence: 99%

Coagulation profile after plasma exchange using albumin as a replacement solution measured by thromboelastometry

et al. 2015

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Validity, regulatory registration and approval of ROTEM thromboelastometry

Cited by 15 publications

References 14 publications

Effect of 6% Hydroxyethyl Starch 130/0.4 as a Priming Solution on Coagulation and Inflammation Following Complex Heart Surgery

Effect of 6% Hydroxyethyl Starch 130/0.4 as a Priming Solution on Coagulation and Inflammation Following Complex Heart Surgery

Comparison of thromboelastometry with procalcitonin, interleukin 6, and C-reactive protein as diagnostic tests for severe sepsis in critically ill adults

Coagulation profile after plasma exchange using albumin as a replacement solution measured by thromboelastometry

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