Point-of-care versus central laboratory coagulation testing during haemorrhagic surgery

Pierre Toulon; Yves Ozier; Annick Ankri; Marie-Hélène Fléron; Geneviève Leroux; Charles Marc Samama

doi:10.1160/TH08-06-0383

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2009; 101(02): 394-401
DOI: 10.1160/TH08-06-0383

New Technologies, Diagnostic Tools and Drugs

Schattauer GmbH

Point-of-care versus central laboratory coagulation testing during haemorrhagic surgery

A multicenter study

Authors

Pierre Toulon

¹Université de Nice-Sophia Antipolis, Faculté de Médecine, Service d’Hématologie Biologique, Nice, France

²Service d’Hématologie Biologique, Université Paris Descartes, Hôpital Cochin, Paris, France
Yves Ozier

³Département d’Anesthésie-Réanimation, Université Paris Descartes, Hôpital Cochin, Paris, France
Annick Ankri

⁴Service d’Hématologie Biologique, Hôpital La-Pitié-Salpétrière, Paris, France
Marie-Hélène Fléron

⁵Département d’AnesthésieRéanimation, Hôpital La-Pitié-Salpétrière, Paris, France
Geneviève Leroux

⁶Laboratoire d’Hématologie, Hôpital Avicenne, Bobigny, France
Charles Marc Samama

⁷Département d’Anesthésie-Réanimation, Hôpital Avicenne, Bobigny, France

Abstract

Summary

Delay in collecting coagulation test results from a central laboratory is one of the critical issues to efficiently control haemostasis during surgery. The aim of this multicenter study was to compare the performance of a point-of-care (POC) device (CoaguChek^™ Pro DM) with the central laboratory-based coagulation testing during haemorrhagic surgery. For this purpose, 93 patients undergoing major surgical procedure were prospectively included in three centers. Blood was drawn from all patients before surgical incision and from most patients during surgical procedure after a blood loss of 25% or more was observed. When expressed in activity percentage, POC-based prothrombin time (PT) was in good agreement with central laboratory test result with coefficient of correlation in the range from 0.711 to 0.960 in the three centers. Comparison was less conclusive when PT was expressed in seconds or as the patient-to-control ratio and for activated partial thromboplastin time, with significantly shorter clotting times and lower ratios obtained on the POC device. On-site PT (in activity percentage) monitoring would have induced no significant change in fresh frozen plasma (FFP) transfusion in patients when compared to central laboratory monitoring. Test results were obtained in less than 5 minutes when performed using the POC device versus a median turnaround time of 88 minutes (range: 29–235 minutes) when blood collection tubes were sent to the central laboratory. These results suggest that, in providing a rapid answer, POC-based monitoring of PT (in percentage) using the CoaguChek device could be validly used in patients undergoing haemorrhagic surgical procedures.

Keywords

Point of care - coagulation - testing - surgery - haemorrhage - transfusion - fresh frozen plasma

Full Text

References

References
1 O’Shaughnessy DF, Atterbury C, Bolton Maggs P. et al. British Committee for Standards in Haematology, Blood Transfusion Task Force.. Guidelines for the use of fresh frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol 2004; 126: 11-28.
2 American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies.. Practice guidelines for perioperative blood transfusion and adjuvant therapies. An updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Transfusion and Adjuvant Therapies. Anesthesiology 2006; 105: 198-208.
3 AFSSAPS.. Transfusion de plasma frais congelé: produits, indications. 2002 http://agmed.sante.gouv.fr/pdf/5/rbp/tpfarg.pdf
4 Kozek-Langenecker S. Management of massive operative blood loss. Minerva Anestesiol 2007; 73: 401-415.
5 Ketchum L, Hess JR, Hiippala S. Indications for early fresh frozen plasma, cryoprecipitate, and platelet transfusion in trauma. J Trauma 2006; 60 Suppl S51-S58.
6 Samama CM, Ozier Y. Near-patient testing of haemostasis in the operating theatre: an approach to appropriate use of blood in surgery. Vox Sang 2003; 84: 251-255.
7 Sie P, Steib A. Central laboratory and point of care assessment of perioperative hemostasis. Can J Anesth 2006; 53 (06) S12-S20.
8 Jahn UR, Van Aken H. Editorial I: Near-patient testing-point-of-care or point of costs and convenience?. Br J Anaesth 2003; 90: 425-427.
9 Stief TW, Fareed J. Point of care: diagnostics in hemostasis – the wrong direction?. J Clin Appl Thromb Hemost 2003; 9: 191-195.
10 Vacas M, Lafuente PJ, Cuesta S. et al. Comparative study of a portable monitor for prothrombin time determination, Coaguchek, with three systems for control of oral anticoagulant treatment. Haemostasis 1998; 28: 321-328.
11 van den Besselar AMHP. A comparison of INRs determined with a whole blood prothrombin time device and two international reference preparations for thromboplastin. Thromb Haemost 2000; 84: 410-412.
12 Attermann J, Andersen NT, Korsgaard H. et al. Precision of INR measured with a patient operated whole blood coagulometer. Thromb Res 2003; 110: 65-68.
13 Fitzmaurice DA, Murray ET, Gee KM. et al. A randomised controlled trial of patient self management of oral anticoagulation treatment compared with primary care management. J Clin Pathol 2002; 55: 845-849.
14 Hasenkam JM, Knudsen L, Kimose HH. et al. Practicability of patient self-testing of oral anticoagulant therapy by the international normalized ratio (INR) using a portable whole blood monitor. A pilot investigation. Thromb Res 1997; 85: 77-82.
15 Bauman ME, Black KL, Massicotte MP. et al. Accuracy of the CoaguChek XS for point-of-care international normalized ratio measurement in children requiring warfarin. Thromb Haemost 2008; 99: 1097-1103.
16 Samama CM, Quezada R, Riou B. et al. Intraoperative measurement of activated partial thromboplastin time and prothrombin time with a new compact monitor. Acta Anaesthesiol Scand 1994; 38: 232-237.
17 Boldt J, Walz G, Triem J, Suttner S, Kumle B. Point-of-care (POC) measurement of coagulation after cardiac surgery. Intensive Care Med 1998; 24: 1187-1193.
18 Jack J, Chavez JJ, Weatherall JS. et al. Evaluation of a point-of-care coagulation analyzer on patients undergoing cardiopulmonary bypass surgery. J Clin Anesth 2004; 16: 7-10.
19 Zalunardo MP, Zollinger A, Seifert B. et al. Peri-operative reliability of an on-site prothrombin time assay under different haemostatic conditions. Br J Anaesth 1998; 81: 533-536.
20 ISO 6710. 1995 Single-use containers for venous blood specimen collection. Version 1996–02. ISO Editions 1996.
21 Walker ID. Blood collection and sample preparation: pre-analytical variation. In: Jespersen J, Bertina RM, Haverkate F. (editors). Laboratory techniques in thrombosis – A manual. 2^nd revised edition of ECAT assay procedures. Dordrecht, The Netherlands: Kluwer Academic Publishers; 1999: 21-28.
22 Polack B, Schved J-F, Boneu B. on behalf of the ‘Groupe d’Etude sur l‘Hémostase et la Thrombose’ [GEHT]. Preanalytical recommendations of the ‘Groupe d’Etude sur l‘Hémostase et la Thrombose’ (GEHT) for venous blood testing in hemostasis laboratories. Haemostasis 2001; 31: 61-68.
23 Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; I: 307-310.
24 Ferring M, Reber G, de Moerloose P, Merlani P, Diby M, Ricou B. Point of care and central laboratory determinations of the aPTT are not interchangeable in surgical intensive care patients. Can J Anaesth 2001; 48: 1155-1160.
25 Johi RR, Cross MH, Hansbro SD. Near-patient testing for coagulopathy after cardiac surgery. Br J Anaesth 2003; 90: 499-501.
26 Murray D, Pennell B, Olson J. Variability of prothrombin time and activated partial thromboplastin time in the diagnosis of increased surgical bleeding. Transfusion 1999; 39: 56-62.
27 Despotis GJ, Alsoufiev A, Goodnough LT. et al. Aprotinin prolongs whole blood activated partial thromboplastin time but not whole blood prothrombin time in patients undergoing cardiac surgery. Anesth Analg 1995; 81: 919-924.
28 Guidelines for point-of-care testing: haematology. Br J Haematol 2008; 142: 904-915.