Validity, regulatory registration and approval of ROTEM thromboelastometry

Blood Coagulation and Fibrinolysis

Volumn 21, Issue 1, 2010, Pages 106-107

  Ebinger, Thomas ^a   Ruland, An ^a   Lakner, Meret ^a   Schwaiger, Martin ^a  

^a Pentapharm GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING DISORDER; LETTER; POLICY; PRIORITY JOURNAL; THROMBOELASTOGRAPHY; VALIDITY;

BLOOD COAGULATION DISORDERS; BLOOD COAGULATION TESTS; DEVICE APPROVAL; EQUIPMENT DESIGN; EUROPEAN UNION; GERMANY; HUMANS; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; THROMBELASTOGRAPHY; VALIDATION STUDIES AS TOPIC;

EID: 75649103625     PISSN: 09575235     EISSN: None     Source Type: Journal    
DOI: 10.1097/MBC.0b013e3283306e28     Document Type: Letter

References (15)

1. Calatzis AL, Haas S, Gö dje O, Calatzis AL, Hipp R, Walenga J. Thromboelastographic coagulation monitoring during cardiovascular surgery with the ROTEG coagulation analyzer. In: Roque Pifarré (ed.), Management of bleeding in cardiovascular surgery. Philadelph: Hanley & Belfus; 2000, pp. 215-226.
2. Hartert H. Blutgerinnungsstudien mit der Thrombelastographie, einem neuen Untersuchungs-verfahren. Klin Wochenschr 1948; 26:577-583.
3. Lang T, Bauters A, Braun SL, Potzsch B, von Pape KW, Kolde HJ, Lakner M. Multicentre investigation on reference ranges for ROTEM thromboelastometry. Blood Coagul Fibrinolysis 2005; 16:301-310.
4. Coakley M, Reddy K, Mackie I, Mallett S. Transfusion triggers in orthotopic liver transplantation: a comparison of ROTEM, thromboelastography and conventional coagulation tests. J Cardiothor Vasc Anesth 2006; 20:548-553.
5. Savry C, Quinio PH, Bouche O, Mouline J, Struillou L, Paysant Y, Schmitt F. Manageability and potential for haemostasis monitoring by near-patient modified thromboelastometer (Rotem) in intensive care unit. Ann Fr Anesth Reanim 2005; 24:607-616.
6. Levrat A, Gross A, Rugeri L, Inaba K, Floccard B, Negrier C, David J-S David. Evaluation of rotation thrombelastography for the diagnosis of hyperfibrinolysis in trauma patients. Br J Anaesth 2008; 100:792-797.
7. Lang T, Johanning K, Metzler H, Piepenbrock S, Solomon C, Rahe-Meyer N, Tanaka KA. The effects of fibrinogen levels on thrombo-elastometric variables in the presence of thrombocytopenia. Anesth Analg 2009; 108:751-758.
8. Schroeder V, Chatterjee T, Kohler H-P. Influence of blood coagulation Factor XIII and FXIII Val 34Leu on plasma clot formation measured by thromboelastography. Thromb Res 2001; 104:467-474.
9. Fries D, Krismer A, Klinger A, Streif W, Klima G, Wenzel V, et al. Effect of fibrinogen substitution on reversal of dilutional coagulopathy: an in vitro model. Anesth Analg 2006; 102:347-351.
10. Mittermayr M, Streif W, Haas T, Fries D, Velik-Salchner C, Klingler A, et al. Hemostatic changes after crystalloid or colloid fluid administration during major orthopedic surgery: the role of fibrinogen administration. Anesth Analg 2007; 105:905-917.
11. Kettner SC, Panzer OP, Kozek SA, Seibt FA, Stoiser B, Kofler J, et al. Use of abciximab-modified thrombo-elastography in patients undergoing cardiac surgery. Anesth Analg 1999; 89:580-584.
12. Mittermayer M, Margreiter J, Velik-Salchner C, Klingler A, Streif W, Fries D, Innerhofer P. Effects of protamine and heparin can be detected and easily differentiated by modified thromboelastography (ROTEM1): an in vitro study. Br J Anaesth 2005; 95:310-316.
13. Cammerer U, Dietrich T, Rampf SL, Braun W, Richter JA. The predictive value of modified computerized thromboelastography and platelet function analysis for postoperative blood loss in routine cardiac surgery. Anesth Analg 2003; 96:51-57.
14. Anderson L, Quasim I, Soutar R, Steven M, Macfie A, Korte W. An audit of red cell and blood product use after the institution of thromboelastometry in a cardiac intensive care unit. Transfus Med 2006; 16:31-39.
15. Spalding GJ, Hartrumpf M, Sierig T, Oesberg N, Kirschke CG, Albes JM. Cost reduction of perioperative coagulation management in cardiac surgery: value of 'bedside' thrombelastography (ROTEM). Eur J Cardiothorac Surg 2007; 31:1052-1057.