Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial

Circulation

Volumn 134, Issue 16, 2016, Pages 1152-1162

  Karkouti, Keyvan ^a,f   Callum, Jeannie ^b   Wijeysundera, Duminda N ^a,f   Rao, Vivek ^a,f   Crowther, Mark ^c   Grocott, Hilary P ^d   Pinto, Ruxandra ^e   Scales, Damon C ^e   Achen, B ^g   Brar, S ^h   Morrison, D ^h   Wong, D ^h   Bussieres J S ⁱ   De Waal, T ^j   Harle, C ^k   De Medicis E ^l   McAdams, C ^m   Syed, S ^c   Tran, D ⁿ   Waters, T ^o  

^a TORONTO GENERAL HOSPITAL   (Canada)

^b SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^c MCMASTER UNIVERSITY   (Canada)

^d UNIVERSITY OF MANITOBA   (Canada)

^e UNIVERSITY OF TORONTO   (Canada)

^f UNIVERSITY HEALTH NETWORK   (Canada)

^g University Hospital   (Canada)

^h ROYAL COLUMBIAN HOSPITAL   (Canada)

ⁱ LAVAL UNIVERSITY   (Canada)

^j SOUTHLAKE REGIONAL HEALTH CENTRE   (Canada)

^k LONDON HEALTH SCIENCES CENTRE   (Canada)

^l CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE   (Canada)

^m Alberta Health Services   (Canada)

ⁿ UNIVERSITY OF OTTAWA HEART INSTITUTE   (Canada)

^o VANCOUVER COASTAL HEALTH   (Canada)

more..

Author keywords

cardiopulmonary bypass; clinical trial; coagulation; hemorrhage; hemostasis

Indexed keywords

CREATININE; FIBRINOGEN CONCENTRATE; HEMOGLOBIN; PROTHROMBIN COMPLEX;

ACUTE KIDNEY FAILURE; ADULT; AGED; ARTICLE; BLOOD CLOTTING DISORDER; BODY SURFACE; CARDIOPULMONARY BYPASS; CLINICAL OUTCOME; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CRYOPRECIPITATE; DEEP VEIN THROMBOSIS; ERYTHROCYTE TRANSFUSION; ESTIMATED GLOMERULAR FILTRATION RATE; FEMALE; HEART INFARCTION; HEART SURGERY; HEMOGLOBIN DETERMINATION; HEMOSTATIC TECHNIQUE; HUMAN; INTERNATIONAL NORMALIZED RATIO; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORTALITY RATE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PLASMA TRANSFUSION; POINT OF CARE TESTING; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RENAL REPLACEMENT THERAPY; SEPSIS; THROMBOCYTE COUNT; THROMBOCYTE TRANSFUSION; ADVERSE EFFECTS; ALGORITHM; BLOOD CLOTTING TEST; BLOOD COAGULATION DISORDERS; BLOOD TRANSFUSION; CLINICAL TRIAL; DISEASE MANAGEMENT; HEMORRHAGE; HEMOSTASIS; MIDDLE AGED; PERIOPERATIVE PERIOD; POINT OF CARE SYSTEM; PROCEDURES; TREATMENT OUTCOME;

AGED; ALGORITHMS; BLOOD COAGULATION DISORDERS; BLOOD COAGULATION TESTS; BLOOD TRANSFUSION; CARDIAC SURGICAL PROCEDURES; DISEASE MANAGEMENT; FEMALE; HEMORRHAGE; HEMOSTASIS; HUMANS; MALE; MIDDLE AGED; PERIOPERATIVE CARE; POINT-OF-CARE SYSTEMS; TREATMENT OUTCOME;

EID: 84988624825     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.116.023956     Document Type: Article

References (44)

1. Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, Saha SP, Song HK, Clough ER, Shore-Lesserson LJ, Goodnough LT, Mazer CD, Shander A, Stafford-Smith M, Waters J, Baker RA, Dickinson TA, FitzGerald DJ, Likosky DS, Shann KG. 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines. Ann Thorac Surg 2011;91:944-82
2. Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leão WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010;304:1559-1567. doi: 10.1001/ jama.2010.1446.
3. Despotis G, Eby C, Lublin DM. A review of transfusion risks and optimal management of perioperative bleeding with cardiac surgery. Transfusion. 2008;48(1 suppl):2S-30S. doi: 10.1111/j.1537-2995.2007.01573.x.
4. Spahn DR, Goodnough LT. Alternatives to blood transfusion. Lancet. 2013;381:1855-1865. doi: 10.1016/S0140-6736(13)60808-9.
5. Karkouti K, Wijeysundera DN, Yau TM, Beattie WS, Abdelnaem E, McCluskey SA, Ghannam M, Yeo E, Djaiani G, Karski J. The independent association of massive blood loss with mortality in cardiac surgery. Transfusion. 2004;44:1453-1462. doi: 10.1111/j.1537-2995.2004.04144.x.
6. Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007;116:2544-2552. doi: 10.1161/CIRCULA-TIONAHA.107.698977.
7. Ranucci M. Outcome measures and quality markers for periopera-tive blood loss and transfusion in cardiac surgery. Can J Anesth. 2016;63:169-175. doi: 10.1007/s12630-015-0515-8.
8. Rich MW, Chyun DA, Skolnick AH, Alexander KP, Forman DE, Kitzman DW, Maurer MS, McClurken JB, Resnick BM, Shen WK, Tirschwell DL; American Heart Association Older Populations Committee of the Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council; American College of Cardiology; and American Geriatrics Society. Knowledge gaps in cardiovascular care of the older adult population: a scientific statement from the American Heart Association, American College of Cardiology, and American Geriatrics Society. Circulation. 2016;133:2103- 2122. doi: 10.1161/CIR.0000000000000380.
9. Kozek-Langenecker SA, Afshari A, Albaladejo P, Santullano CA, De Robertis E, Filipescu DC, Fries D, Görlinger K, Haas T, Imberger G, Jacob M, Lancé M, Llau J, Mallett S, Meier J, Rahe-Meyer N, Samama CM, Smith A, Solomon C, Van der Linden P, Wikkelsø AJ, Wouters P, Wyffels P. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesi-ology. Eur J Anaesthesiol. 2013;30:270-382. doi: 10.1097/ EJA.0b013e32835f4d5b.
10. National Institute for Clinical Excellence. Detecting, managing and monitoring haemostasis: viscoelastometric point-of-care testing (ROTEM, TEG, and Sonoclot systems). Diagnostics Guidance 13. 2014. https://www.nice.org.uk/guidance/dg13 Accessed September 2, 2016.
11. Whiting D, DiNardo JA. TEG and ROTEM: technology and clinical applications. Am J Hematol. 2014;89:228-232. doi: 10.1002/ ajh.23599.
12. Weber CF, Klages M, Zacharowski K. Perioperative coagulation management during cardiac surgery. Curr Opin Anaesthesiol. 2013;26:60-64. doi: 10.1097/ACO.0b013e32835afd28.
13. Spahn DR. TEG®- or ROTEM®-based individualized goal-directed coagulation algorithms: don't wait-act now! Crit Care. 2014;18:637. doi: 10.1186/s13054-014-0637-3.
14. Sniecinski RM, Karkouti K, Levy JH. Managing clotting: a North American perspective. Curr Opin Anaesthesiol. 2012;25:74-79. doi: 10.1097/ACO.0b013e32834ebd59.
15. Afshari A, Wikkelso A, Brok J, Moller AM, Wetterslev J. Thromb-elastography (TEG) or thromboelastometry (ROTEM) to monitor haemotherapy versus usual care in patients with massive transfusion. Cochrane Database Syst Rev 2011;CD007871
16. Pape A, Weber CF, Stein P, Zacharowski K. ROTEM and multiplate - a suitable tool for POC? ISBT Science Series 2010;5:161-168.
17. Ogawa S, Szlam F, Chen EP, Nishimura T, Kim H, Roback JD, Levy JH, Tanaka KA. A comparative evaluation of rotation throm-boelastometry and standard coagulation tests in hemodilution-induced coagulation changes after cardiac surgery. Transfusion. 2012;52:14-22. doi: 10.1111/j.1537-2995.2011.03241.x.
18. Ponschab M, Voelckel W, Pavelka M, Schlimp CJ, Schöchl H. Effect of coagulation factor concentrate administration on ROTEM® parameters in major trauma. Scand J Trauma Resusc Emerg Med. 2015;23:84. doi: 10.1186/s13049-015-0165-4.
19. Theusinger OM, Schröder CM, Eismon J, Emmert MY, Seifert B, Spahn DR, Baulig W. The influence of laboratory coagulation tests and clotting factor levels on Rotation Thromboelastometry (ROTEM®) during major surgery with hemorrhage. Anesth Analg. 2013;117:314-321. doi: 10.1213/ANE.0b013e31829569ac.
20. Mace H, Lightfoot N, McCluskey S, Selby R, Roy D, Timoumi T, Karkouti K. Validity of thromboelastometry for rapid assessment of fibrinogen levels in heparinized samples during cardiac surgery: a retrospective, single-center, observational study. J Cardiothorac Vasc Anesth. 2016;30:90-95. doi: 10.1053/j.jvca.2015.04.030.
21. Ogawa S, Szlam F, Bolliger D, Nishimura T, Chen EP, Tanaka KA. The impact of hematocrit on fibrin clot formation assessed by rotational thromboelastometry. Anesth Analg. 2012;115:16-21. doi: 10.1213/ANE.0b013e31824d523b.
22. Campbell J, Ridgway H, Carville D. Plateletworks: a novel point of care platelet function screen. Mol Diagn Ther. 2008;12:253-258.
23. Orlov D, McCluskey SA, Selby R, Yip P, Pendergrast J, Kar-kouti K. Platelet dysfunction as measured by a point-of-care monitor is an independent predictor of high blood loss in cardiac surgery. Anesth Analg. 2014;118:257-263. doi: 10.1213/ ANE.0000000000000054.
24. Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sørensen B, Hagl C, Pichlmaier M. Effects of fibrin-ogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiol-ogy. 2013;118:40-50. doi: 10.1097/ALN.0b013e3182715d4d.
25. Ghadimi K, Levy JH, Welsby IJ. Prothrombin complex concentrates for bleeding in the perioperative setting. Anesth Analg. 2016;122:1287-1300. doi: 10.1213/ ANE.0000000000001188.
26. Tanaka KA, Key NS, Levy JH. Blood coagulation: hemostasis and thrombin regulation. Anesth Analg. 2009;108:1433-1446. doi: 10.1213/ane.0b013e31819bcc9c.
27. Karkouti K, McCluskey SA, Callum J, Freedman J, Selby R, Timoumi T, Roy D, Rao V. Evaluation of a novel transfusion algorithm employing point-of-care coagulation assays in cardiac surgery: a retrospective cohort study with interrupted time-series analysis. Anesthesiology. 2015;122:560-570. doi: 10.1097/ ALN.0000000000000556.
28. Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ra-nucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014;147:1458-1463. e1. doi: 10.1016/j.jtcvs.2013.10.070.
29. Kinnunen EM, Juvonen T, Airaksinen KE, Heikkinen J, Kettunen U, Mariscalco G, Biancari F. Clinical significance and determinants of the universal definition of perioperative bleeding classification in patients undergoing coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2014;148:1640-1646.e2. doi: 10.1016/j. jtcvs.2014.07.040.
30. Ricci Z, Cruz DN, Ronco C. Classification and staging of acute kidney injury: beyond the RIFLE and AKIN criteria. Nat Rev Nephrol. 2011;7:201-208. doi: 10.1038/nrneph.2011.14.
31. Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350:h391.
32. Webert KE, Alam AQ, Chargé SB, Sheffield WP. Platelet utilization: a Canadian Blood Services research and development symposium. Transfus Med Rev. 2014;28:84-97. doi: 10.1016/j. tmrv.2014.01.002.
33. Yelland LN, Salter AB, Ryan P. Performance of the modified Pois-son regression approach for estimating relative risks from clustered prospective data. Am J Epidemiol. 2011;174:984-992. doi: 10.1093/aje/kwr183.
34. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28:182- 191. doi: 10.1016/j.cct.2006.05.007.
35. Ferraris VA, Ferraris SP, Saha SP, Hessel EA, Haan CK, Royston BD, Bridges CR, Higgins RS, Despotis G, Brown JR, Spiess BD, Shore-Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S. Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline. Ann Thorac Surg 2007; 83: S27-S86
36. Karkouti K, O'Farrell R, Yau TM, Beattie WS; Reducing Bleeding in Cardiac Surgery Research Group. Prediction of massive blood transfusion in cardiac surgery. Can J Anaesth. 2006;53:781-794. doi: 10.1007/BF03022795.
37. Karkouti K, Wijeysundera DN, Beattie WS, Callum JL, Cheng D, Du-puis JY, Kent B, Mazer D, Rubens FD, Sawchuk C, Yau TM; Reducing Bleeding in Cardiac Surgery (RBC) Research Group. Variability and predictability of large-volume red blood cell transfusion in cardiac surgery: a multicenter study. Transfusion. 2007;47:2081- 2088. doi: 10.1111/j.1537-2995.2007.01432.x.
38. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
39. Karkouti K, Arellano R, Aye T, Dupuis JY, Kent B, Lee TW, Lin Y, Ral-ley F, MacAdams C, Mazer CD, Muirhead B, Rheault MR, Rochon A, Syed S, Waters T, Wong B. Off-label use of recombinant activated factor VII in surgical and non-surgical patients at 16 Canadian hospitals from 2007 to 2010 (Canadian Registry Report). Can J Anesth. 2014;61:727-735. doi: 10.1007/s12630-014-0184-z.
40. Weber CF, Görlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012;117:531-547. doi: 10.1097/ALN.0b013e318264c644.
41. Bolliger D, Tanaka KA. Roles of thrombelastography and throm-boelastometry for patient blood management in cardiac surgery. Transfus Med Rev. 2013;27:213-220. doi: 10.1016/j. tmrv.2013.08.004.
42. Bellomo R, Warrillow SJ, Reade MC. Why we should be wary of single-center trials. Crit Care Med. 2009;37:3114-3119. doi: 10.1097/CCM.0b013e3181bc7bd5.
43. Carless PA, Henry DA, Moxey AJ, O'Connell D, Brown T, Fergus-son DA: Cell salvage for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev 2010;CD001888
44. Djaiani G, Fedorko L, Borger MA, Green R, Carroll J, Mar-con M, Karski J. Continuous-flow cell saver reduces cognitive decline in elderly patients after coronary bypass surgery. Circulation. 2007;116:1888-1895. doi: 10.1161/CIRCULA-TIONAHA.107.698001.