HPE CSL Managing Perioperative Bleeding handbook - Page 21

Paediatrics However, clinical efficacy of FXIII administration to treat acquired FXIII deficiency in paediatric surgery is currently based on clinical observation rather than on evidence-based data. a significantly less volume than plasma transfusion. Although more clinical data in children are needed, this approach seems very likely to permit rapid and effective targeted management. Recombinant activated FVII Management of intractable bleeding has led to a call for a defined rescue therapy. Although it is well known that some prerequisites including normothermia, undisturbed acid–base status, and normal calcium levels, as well as sufficient platelet count and plasma fibrinogen levels are the mainstay for adequate clot building, many authors have declared a special role in improving thrombin potential to enable cessation of bleeding. Therefore, administration of recombinant activated FVII (rFVIIa) has been advocated, whereby clinical evidence to support its use are lacking. Activated rFVII is licensed for the treatment of patients with haemophilia A or B with inhibitors, and patients with congenital FVII deficiency. In Europe, additional approval was granted for treatment of Glanzmann’s thrombasthenia. There are published data for the off-label treatment using rFVIIa to stop severe bleeding in children with bleeding during neurosurgical procedures 39,40 and cardiac surgery. 41 It has been hypothesised that administration of rFVIIa for treatment of severe bleeding in adults may only be efficacious if critical amounts of fibrinogen and platelets have been established. 3 As no clear dose has been established, sound evidence-based data are lacking, and the treatment using rFVIIa increases thromboembolic risk considerably, a recent Cochrane analysis has advocated against the use of rFVIIa outside its licensed indications. 42 References 1 Haas T et al. Management of dilutional coagulopathy during pediatric major surgery. Transfus Med Hemother 2012;39:114–19. 2 American Society of Anesthesiologists Task Force on Perioperative Blood M. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management. Anesthesiology 2015;122:241–75. 3 Kozek-Langenecker SA et al. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol 2017;34:332–95. 4 El Kady N et al. Perioperative assessment of coagulation in paediatric neurosurgical patients using thromboelastography. Eur J Anaesthesiol 2009;26:293–7. 5 Romlin BS et al. Earlier detection of coagulopathy with thromboelastometry during pediatric cardiac surgery: a prospective observational study. Paediatr Anaesth 2013;23:222–7. 6 Faraoni D et al. Developm ent of a specific algorithm to guide haemostatic therapy in children undergoing cardiac surgery: a single-centre retrospective study. Eur J Anaesthesiol 2015;32:320–9. 7 Faraoni D et al. Plasma fibrinogen concentration is correlated with postoperative blood loss in children undergoing cardiac surgery. A retrospective review. Eur J Anaesthesiol 2014;31:317–26. 8 Nakayama Y et al. Thromboelastometry-guided intraoperative haemostatic management reduces bleeding and red cell transfusion after paediatric cardiac surgery. Br J Anaesth 2015;114:91–102. 9 Weber CF et al. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology 2012;117:531–47. 10 Haas T et al. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial. Br J Anaesth 2015;115:234–43. 11 Levy JH, Welsby I, Goodnough LT. Fibrinogen as a therapeutic target for bleeding: a review of critical levels and replacement therapy. Transfusion 2014;54:1389–1405; quiz 1388. 12 Levy JH et al. Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesth Analg 2012;114:261–74. 13 Sorensen B et al. Fibrinogen as a hemostatic agent. Semin Thromb Haemost 2012;38:268–73. 14 Fenger-Eriksen C et al. Mechanisms of hydroxyethyl starch-induced dilutional coagulopathy. J Thromb Haemost 2009;7:1099–105. 15 Levy JH. Massive transfusion coagulopathy. Semin Hematol 2006;43:S59–S63. 16 Fries D. [Dilutional coagulopathy: development, diagnostic options and management]. Haemostaseologie 2006;26:S15–S19. 17 Kozek-Langenecker S. Management of massive operative blood loss. Minerva Anestesiol 2007;73:401–15. 18 Innerhofer P, Kienast J. Principles of perioperative coagulopathy. Best practice and research. Clin Anaesthesiol 2010;24:1–14. 19 Rossaint R et al. Management of bleeding following major trauma: an updated European guideline. Crit Care 2010;14:R52. 20 Haas T et al. Fibrinogen in craniosynostosis surgery. Anesth Analg 2008;106:725–31. 21 Rahe-Meyer N et al. Thromboelastometry-guided administration of fibrinogen concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery. J Thorac Cardiovasc Surg 2009;138:694–702. 22 Fenger-Eriksen C et al. Fibrinogen substitution Conclusions Prompt and timely identification of the underlying coagulopathy and, consequently, individualised treatment of depleted factors are the mainstay of a modern and advanced coagulation management. The use of coagulation factors as part of an algorithm offers great advantages for effective bleeding management, as it does not require cross-matching or thawing, is almost immediately available, it does not alter serum ionised calcium level, it is less immunogeneic, the increase in desired coagulation factor levels can be reliably calculated, and it can be administered in improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial. J Thromb Haemost 2009;7:795–802. 23 Fenger-Eriksen C et al. Fibrinogen concentrate substitution therapy in patients with massive haemorrhage and low plasma fibrinogen concentrations. Br J Anaesth 2008;101:769–73. 24 Danes AF et al. Efficacy and tolerability of human fibrinogen concentrate administration to patients with acquired fibrinogen deficiency and active or in high-risk severe bleeding. Vox Sang 2008;94:221–6. 25 Weinkove R, Rangarajan S. Fibrinogen concentrate for acquired hypofibrinogenaemic states. Transfus Med 2008;18:151–7. 26 Dickneite G et al. Animal model and clinical evidence indicating low thrombogenic potential of fibrinogen concentrate (Haemocomplettan P). Blood Coagul Fibrinolysis 2009;20:535–40. 27 Manco-Johnson MJ et al. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost 2009;7:2064–9. 28 Haas T et al. Economic aspects of intraoperative coagulation management targeting higher fibrinogen concentrations during major craniosynostosis surgery. Paediatr Anaesth 2016;26:77–83. 29 Galas FR et al. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg 2014;148:1647–55. 30 Tirotta C et al. Use of human fibrinogen concentrate in pediatric cardiac surgery. Int J Anesthetic Anesthesiol 2015;2:1–6. 31 Fominskiy E et al. Efficacy and safety of fibrinogen concentrate in surgical patients: A meta-analysis of randomized controlled trials. J Cardiothorac Vasc Anesth 2016;30:1196–1204. 32 Despotis G, Eby C, Lublin DM. A review of transfusion risks and optimal management of perioperative bleeding with cardiac surgery. Transfusion 2008;48:2S–30S. 33 Butchart EG et al. Exercise Physiology ESoC. Recommendations for the management of patients after heart valve surgery. Eur Heart J 2005;26: 2463–71. 34 Noga T et al. Four-factor prothrombin complex concentrates in paediatric patients – a retrospective case series. Vox Sang 2016;110:253–7. 35 Franklin SW et al. Optimizing thrombin generation with 4-Factor prothrombin complex concentrates in neonatal plasma after cardiopulmonary bypass. Anesth Analg 2016;122:935–42. 36 Rech MA et al. Prothrombin complex concentrate for intracerebral hemorrhage secondary to vitamin K deficiency bleeding in a 6-week-old child. J Pediatr 2015;167:1443–4. 37 Korte W. [Fibrin monomer and factor XIII: a new concept for unexplained intraoperative coagulopathy]. Hamostaseologie 2006;26:S30–35. 38 Haas T et al. Perioperative course of FXIII in children undergoing major surgery. Paediatr Anaesth 2012;22(7):641–6. 39 Uhrig L et al. Use of recombinant activated factor VII in intractable bleeding during pediatric neurosurgical procedures. Pediatr Crit Care Med 2007;8:576–9. 40 Heisel M et al. Use of recombinant factor VIIa (rFVIIa) to control intraoperative bleeding in pediatric brain tumor patients. Pediatr Blood Cancer 2004;43:703–05. 41 Ekert H et al. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis 2006;17:389–95. 42 Simpson E et al. Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia. Cochrane Database Sys Rev 2012;3:CD005011. hospitalpharmacyeurope.com 21