Is perioperative point-of-care prothrombin time testing accurate compared to the standard laboratory test?

Summary

There is no accepted way of measuring prothrombin time without time loss for patients undergoing major surgery who are at risk of intraoperative dilution and consumption coagulopathy due to bleeding and volume replacement with crystalloids or colloids. Decisions to transfuse fresh frozen plasma and procoagulatory drugs have to rely on clinical judgment in these situations. Point-of-care devices are considerably faster than the standard laboratory methods. In this study we assessed the accuracy of a Point-of-care (PoC) device measuring prothrombin time compared to the standard laboratory method. Patients undergoing major surgery and intensive care unit patients were included. PoC prothrombin time was measured by CoaguChek^® XS Plus (Roche Diagnostics, Switzerland). PoC and reference tests were performed independently and interpreted under blinded conditions. Using a cut-off prothrombin time of 50%, we calculated diagnostic accuracy measures, plotted a receiver operating characteristic (ROC) curve and tested for equivalence between the two methods. PoC sensitivity and specificity were 95% (95% CI 77%, 100%) and 95% (95% CI 91%, 98%) respectively. The negative likelihood ratio was 0.05 (95% CI 0.01, 0.32). The positive likelihood ratio was 19.57 (95% CI 10.62, 36.06). The area under the ROC curve was 0.988. Equivalence between the two methods was confirmed. CoaguChek^® XS Plus is a rapid and highly accurate test compared with the reference test. These findings suggest that PoC testing will be useful for monitoring intraoperative prothrombin time when coagulopathy is suspected. It could lead to a more rational use of expensive and limited blood bank resources.

Keywords

Point-of-care - prothrombin time - coagulation - anaesthesiology - blood loss

Footnote: Received from the University Department of Anesthesiology and Pain Therapy, University Hospital of Bern, Switzerland.

• References

• 1 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.
• 2 Shaz BH, Dente CJ, Harris RS. et al. Transfusion management of trauma patients. Anesth Analg 2009; 108: 1760-1768.
• 3 O’Shaughnessy DF, Atterbury C, Bolton PMaggs. et al. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol 2004; 126: 11-28.
• 4 Bundesaerztekammer. Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives [document on the internet]. Available at: www.bundesaerztekammer.de/downloads/LeitCrossBloodComponents4ed.pdf Accessed: May 5 2009.
• 5 Ruhl H, Bein G, Sachs UJ. Transfusion-associated graft-versus-host disease. Transfus Med Rev 2009; 23: 62-71.
• 6 Marik PE, Corwin HL. Acute lung injury following blood transfusion: expanding the definition. Crit Care Med 2008; 36: 3080-3084.
• 7 Edgren G, Hjalgrim H, Reilly M. et al. Risk of cancer after blood transfusion from donors with subclinical cancer: a retrospective cohort study. Lancet 2007; 369: 1724-1730.
• 8 Stroncek DF, Rebulla P. Platelet transfusions. Lancet 2007; 370: 427-438.
• 9 Brander L, Reil A, Bux J. et al. Severe transfusionrelated acute lung injury. Anesth Analg 2005; 101: 499-501.
• 10 Norda R, Tynell E, Akerblom O. Cumulative risks of early fresh frozen plasma, cryoprecipitate and platelet transfusion in Europe. J Trauma 2006; 60 (Suppl. 06) S41-S45.
• 11 MacLennan S, Williamson LM. Risks of fresh frozen plasma and platelets. J Trauma 2006; 60 (Suppl. 06) S46-S50.
• 12 Jones J. Abuse of fresh frozen plasma. Br Med J (Clin Res Ed) 1987; 295: 287.
• 13 Spence RK. Surgical red blood cell transfusion practice policies. Blood Management Practice Guidelines Conference. Am J Surg 1995; 170 (6A Suppl): 3S-15S.
• 14 Practice Guidelines for blood component therapy: A report by the American Society of Anesthesiologists Task Force on Blood Component Therapy. Anesthesiology 1996; 84: 732-747.
• 15 Spahn DR, Moch H, Hofmann A. et al. Patient blood management: the pragmatic solution for the problems with blood transfusions. Anesthesiology 2008; 109: 951-953.
• 16 Kawai A, Kadota H, Yamaguchi U. et al. Blood loss and transfusion associated with musculoskeletal tumor surgery. J Surg Oncol 2005; 92: 52-58.
• 17 Gottfried ON, Schmidt MH, Stevens EA. Embolization of sacral tumors. Neurosurg Focus 2003; 15: E4
• 18 Owen RJ. Embolization of musculoskeletal tumors. Radiol Clin North Am 2008; 46: 535-543 vi.
• 19 Lier H, Krep H, Schroeder S. et al. Preconditions of hemostasis in trauma: a review. The influence of acidosis, hypocalcemia, anemia, and hypothermia on functional hemostasis in trauma. J Trauma 2008; 65: 951-960.
• 20 Duke University Regional Referral Laboratory Services. Clinical Coagulation laboratory. Available at: www.pathology.mc.duke.edu/coag/TAT.htm Accessed July 4 2009.
• 21 Ketchum L, Hess JR, Hiippala S. Indications for early fresh frozen plasma, cryoprecipitate, and platelet transfusion in trauma. J Trauma 2006; 60 (Suppl. 06) S51-S58.
• 22 Toulon P, Ozier Y, Ankri A. et al. Point-of-care versus central laboratory coagulation testing during haemorrhagic surgery. A multicenter study. Thromb Haemost 2009; 101: 394-401.
• 23 Kozek-Langenecker S. Management of massive operative blood loss. Minerva Anestesiol 2007; 73: 401-415.
• 24 Poller L, Keown M, Ibrahim SA. et al. Quality assessment of CoaguChek point-of-care prothrombin time monitors: comparison of the European community-approved procedure and conventional external quality assessment. Clin Chem 2006; 52: 1843-1847.
• 25 Wong J, El Beheiry H, Rampersaud YR. et al. Tranexamic Acid reduces perioperative blood loss in adult patients having spinal fusion surgery. Anesth Analg 2008; 107: 1479-1486.
• 26 Moore FA, Nelson T, McKinley BA. et al. Is there a role for aggressive use of fresh frozen plasma in massive transfusion of civilian trauma patients?. Am J Surg 2008; 196: 948-960.
• 27 Stravitz RT. Critical management decisions in patients with acute liver failure. Chest 2008; 134: 1092-1102.
• 28 Plesch W, Wolf T, Breitenbeck N. et al. Results of the performance verification of the CoaguChek XS system. Thromb Res 2008; 123: 381-389.
• 29 Gibbs NM. The effect of anaesthetic agents on platelet function. Anaesth Intensive Care 1991; 19: 495-505.
• 30 Niccolai I, Barontini L, Paolini P. et al. Long-term sedation with propofol in ICU: hemocoagulation problems. Minerva Anestesiol 1992; 58: 375-379.
• 31 Fleisher LA, Beckman JA, Brown KA. et al. ACC/ AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. Circulation 2007; 116: e418-499.
• 32 Taborski U, Braun SL, Voller H. Analytical performance of the new coagulation monitoring system INRatio for the determination of INR compared with the coagulation monitor Coaguchek S and an established laboratory method. J Thromb Thrombolysis 2004; 18: 103-107.
• 33 Bauman ME, Black KL, Massicotte MP. et al. Accuracy of the CoaguChek XS for point-of-care international normalized ratio (INR) measurement in children requiring warfarin. Thromb Haemost 2008; 99: 1097-1103.
• 34 University Hospital of Bern, Laboratory of Haematology. Available at: www.hzl.insel.ch/1145.html Accessed July 4 2009.
• 35 Leichsenring I, Plesch W, Unkrig V. et al. Multicentre ISI assignment and calibration of the INR measuring range of a new point-of-care system designed for home monitoring of oral anticoagulation therapy. Thromb Haemost 2007; 97: 856-861.
• 36 Plesch W, van den Besselaar AM. Validation of the international normalized ratio (INR) in a new point-ofcare system designed for home monitoring of oral anticoagulation therapy. Int J Lab Hematol 2009; 31: 20-25.
• 37 Thuerlemann C, Haeberli A, Alberio L. Monitoring thrombin generation by electrochemistry: development of an amperometric biosensor screening test for plasma and whole blood. Clin Chem 2009; 55: 505-512.
• 38 Deom A, Reber G, Tsakiris DA. et al. Evaluation of the CoaguChek XS Plus system in a Swiss community setting. Thromb Haemost 2009; 101: 988-990.
• 39 Poller L. International Normalized Ratios (INR): the first 20 years. J Thromb Haemost 2004; 02: 849-860.
• 40 Favaloro EJ, Hamdam S, McDonald J. et al. Time to think outside the box? Prothrombin time, international normalised ratio, international sensitivity index, mean normal prothrombin time and measurement of uncertainty: a novel approach to standardisation. Pathology 2008; 40: 277-287.
• 41 Preston FE. Quality control and oral anticoagulation. Thromb Haemost 1995; 74: 515-520.
• 42 Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet 1995; 346: 1085-1087.
• 43 Jaeschke R, Guyatt GH, Sackett DL. Users’ guides to the medical literature. III. How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients? The Evidence-Based Medicine Working Group. J Am Med Assoc 1994; 271: 703-707.
• 44 Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987; 15: 657-680.
• 45 Plesch W, Klimpel P. Performance evaluation of the CoaguChek S system. Haematologica 2002; 87: 557-559.
• 46 Horlocker TT, Nuttall GA, Dekutoski MB. et al. The accuracy of coagulation tests during spinal fusion and instrumentation. Anesth Analg 2001; 93: 33-38.
• 47 Inaba K, Teixeira PG, Shulman I. et al. The impact of uncross-matched blood transfusion on the need for massive transfusion and mortality: analysis of 5,166 uncross-matched units. J Trauma 2008; 65: 1222-1226.