A Prospective Randomized Clinical Trial of Efficacy of Algorithm-Based Point of Care Guided Hemostatic Therapy in Cyanotic Congenital Heart Disease Surgical Patients
22 October 2019 (online)
Objective Point of care (POC) testing-based algorithm-guided hemostatic therapy has been used in adult as well as pediatric cardiac surgical patients to administer blood components. The authors hypothesized that implementation of POC-based algorithm in pediatric cyanotic congenital surgical patients would reduce the exposure to blood component therapy and improve the clinical outcome.
Design Prospective randomized control trial.
Setting Single-center academic institute.
Participants One hundred seventy pediatric congenital cyanotic surgical patients.
Intervention Implementation of POC and conventional tests-based algorithms.
Measurements and Main Results Algorithm-based blood component therapy was administered in each group. There were no group differences regarding the demographic, clinical, and laboratory characteristics. Amount of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, and cryoprecipitate (primary outcomes) administered was significantly lower in POC group than that in the conventional group (p < 0.001). Among the secondary outcomes, the chest drain output at 6, 12, and 24 hours and number of re-explorations was comparable among both the groups. The duration of mechanical ventilation, duration of intensive care unit (ICU) stay, and hospital stay was significantly short in POC group (p = 0.008, <0.001 and 0.019, respectively).
Conclusion Implementation of POC-based algorithm-guided hemostatic therapy reduced the exposure to blood and blood component therapy and was associated with reduced ICU and hospital stay in pediatric congenital cyanotic surgical patients.
- 1 Ghasemi A, Horri M, Salahshour Y. et al. Coagulation abnormalities in pediatric patients with congenital heart disease: A Literature Review. Int J Pediatr 2014; 2: 141-143
- 2 Horigome H, Hiramatsu Y, Shigeta O, Nagasawa T, Matsui A. Overproduction of platelet microparticles in cyanotic congenital heart disease with polycythemia. J Am Coll Cardiol 2002; 39 (06) 1072-1077
- 3 Despotis GJ, Gravlee G, Filos K, Levy J. Anticoagulation monitoring during cardiac surgery: a review of current and emerging techniques. Anesthesiology 1999; 91 (04) 1122-1151
- 4 Bolliger D, Szlam F, Levy JH, Molinaro RJ, Tanaka KA. Haemodilution-induced profibrinolytic state is mitigated by fresh-frozen plasma: implications for early haemostatic intervention in massive haemorrhage. Br J Anaesth 2010; 104 (03) 318-325
- 5 Kiefel V. Reactions induced by platelet transfusions. Transfus Med Hemother 2008; 35 (05) 354-358 10.1159/000151350
- 6 Pandey S, Vyas GN. Adverse effects of plasma transfusion. Transfusion 2012; 52 (Suppl. 01) 65S-79S
- 7 Nuttall GA, Oliver WC, Ereth MH, Santrach PJ. Coagulation tests predict bleeding after cardiopulmonary bypass. J Cardiothorac Vasc Anesth 1997; 11 (07) 815-823
- 8 Segal JB, Dzik WH. Transfusion Medicine/Hemostasis Clinical Trials Network. Paucity of studies to support that abnormal coagulation test results predict bleeding in the setting of invasive procedures: an evidence-based review. Transfusion 2005; 45 (09) 1413-1425
- 9 Spalding GJ, Hartrumpf M, Sierig T, Oesberg N, Kirschke CG, Albes JM. Cost reduction of perioperative coagulation management in cardiac surgery: value of “bedside” thromboelastography (ROTEM). Eur J Cardiothorac Surg 2007; 31 (06) 1052-1057
- 10 Coakley M, Reddy K, Mackie I, Mallett S. Transfusion triggers in orthotopic liver transplantation: a comparison of the thromboelastometry analyzer, the thromboelastogram, and conventional coagulation tests. J Cardiothorac Vasc Anesth 2006; 20 (04) 548-553
- 11 Spiess BD, Gillies BSA, Chandler W, Verrier E. Changes in transfusion therapy and re-exploration rate after institution of a blood management program in cardiac surgical patients. J Cardiothorac Vasc Anesth 1995; 9 (02) 168-173
- 12 Li C, Zhao Q, Yang K, Jiang L, Yu J. Thromboelastography or rotational thromboelastometry for bleeding management in adults undergoing cardiac surgery: a systematic review with meta-analysis and trial sequential analysis. J Thorac Dis 2019; 11 (04) 1170-1181
- 13 Ronald A, Dunning J. Can the use of thromboelastography predict and decrease bleeding and blood and blood product requirements in adult patients undergoing cardiac surgery?. Interact Cardiovasc Thorac Surg 2005; 4 (05) 456-463
- 14 Weber CF, Görlinger K, Meininger D. et al. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology 2012; 117 (03) 531-547
- 15 Deppe AC, Weber C, Zimmermann J. et al. Point-of-care thromboelastography/thromboelastometry-based coagulation management in cardiac surgery: a meta-analysis of 8332 patients. J Surg Res 2016; 203 (02) 424-433
- 16 Bhardwaj V, Malhotra P, Hasija S, Chowdury UK, Pangasa N. Coagulopathies in cyanotic cardiac patients: an analysis with three point-of-care testing devices (thromboelastography, rotational thromboelastometry, and sonoclot analyzer). Ann Card Anaesth 2017; 20 (02) 212-218
- 17 Ak K, Isbir CS, Tetik S. et al. Thromboelastography-based transfusion algorithm reduces blood product use after elective CABG: a prospective randomized study. J Card Surg 2009; 24 (04) 404-410
- 18 Faraoni D, Willems A, Romlin BS, Belisle S, Van der Linden P. Development of a specific algorithm to guide haemostatic therapy in children undergoing cardiac surgery: a single-centre retrospective study. Eur J Anaesthesiol 2015; 32 (05) 320-329
- 19 Görlinger K, Dirkmann D, Hanke AA. et al. First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: a retrospective, single-center cohort study. Anesthesiology 2011; 115 (06) 1179-1191
- 20 Nakayama Y, Nakajima Y, Tanaka KA. et al. Thromboelastometry-guided intraoperative haemostatic management reduces bleeding and red cell transfusion after paediatric cardiac surgery. Br J Anaesth 2015; 114 (01) 91-102
- 21 Kuiper GJAJM, van Egmond LT, Henskens YMC. et al. Shifts of transfusion demand in cardiac surgery after implementation of rotational thromboelastometry-guided transfusion protocols: analysis of the HEROES-CS (HEmostasis Registry of patiEntS in Cardiac Surgery) observational, prospective open cohort database. J Cardiothorac Vasc Anesth 2019; 33 (02) 307-317
- 22 Karkouti K, McCluskey SA, Callum J. et al. 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 (03) 560-570
- 23 Redlin M, Kukucka M, Boettcher W. et al. Blood transfusion determines postoperative morbidity in pediatric cardiac surgery applying a comprehensive blood-sparing approach. J Thorac Cardiovasc Surg 2013; 146 (03) 537-542
- 24 Iyengar A, Scipione CN, Sheth P. et al. Association of complications with blood transfusions in pediatric cardiac surgery patients. Ann Thorac Surg 2013; 96 (03) 910-916
- 25 Kestelli M, Tulukoglu E, Yurekli II, Gurbuz A. Think twice while inserting a transannular patch. Eur J Cardiothorac Surg 2009; 35 (06) 1112-1113 author reply 1113
- 26 Pearse BL, Smith I, Faulke D. et al. Protocol guided bleeding management improves cardiac surgery patient outcomes. Vox Sang 2015; 109 (03) 267-279