Document Type : Original Article(s)


1 Associate Professor, Department of Anesthesiology, Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran

2 Critical Care Nurse, Chamran Cardiovascular Medical & Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

3 Student of Medicine, Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran

4 Associate Professor, Department of Surgery, Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran


BACKGROUND: Hypofibrinogenemia is an independent factor of excessive bleeding after congenital cardiac surgeries. Fresh frozen plasma (FFP) and fibrinogen concentrate are examples of recommended products for management of hypofibrinogenemic bleedings. Unfortunately, there is no study to compare these treatments in pediatric cardiac surgeries. Therefore, this study aimed to compare the effect of fibrinogen concentrate with FFP on postoperative bleeding and clinical outcome after congenital cardiac surgeries in pediatric population.METHODS: Phis prospective clinical trial study was carried out on 90 consecutive pediatric patients who underwent congenital cardiac surgeries. The eligible pediatrics who met our study criteria, randomly received FFP (10 ml/kg) or fibrinogen concentrate (70 mg/kg) to assess postoperative bleeding and blood-products requirements.RESULTS: Each of FFP and fibrinogen concentrate significantly reduced total chest tube drainage (CTD) at 3, 6, 12, and 24 postoperative hours (P = 0.04). The analysis of time*intervention revealed that our intervention (fibrinogen group) significantly reduced CTD more (P = 0.01). Moreover, fibrinogen group had a significantly higher plasma fibrinogen level in first 24 hours (P = 0.02).CONCLUSION: Nowadays, both of fibrinogen concentrate and FFP product are widely used for management of hypofibrinogenic bleedings after cardiac surgeries. According to our results, we concluded that although the both product had a comparable effect on management of hypofibrinogenemic bleeding in pediatrics undergoing congenital cardiac surgeries, choosing better product depended on general condition of patients such as their body fluid status. 


  1. O'Shaughnessy DF, Atterbury C, Bolton MP, Murphy M, Thomas D, Yates S, et al. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol 2004; 126(1): 11-28.
  2. Yang L, Vuylsteke A, Gerrard C, Besser M, Baglin T. Postoperative fibrinogen level is associated with postoperative bleeding following cardiothoracic surgery and the effect of fibrinogen replacement therapy remains uncertain. J Thromb Haemost 2013; 11(8): 1519-26.
  3. Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, et al. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: A randomized, placebo-controlled trial. Anesthesiology 2013; 118(1): 40-50.
  4. Cui Y, Hei F, Long C, Feng Z, Zhao J, Yan F, et al. Perioperative monitoring of thromboelastograph on blood protection and recovery for severely cyanotic patients undergoing complex cardiac surgery. Artif Organs 2010; 34(11): 955-60.
  5. Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, 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(4): 1647-55.
  6. Salvin JW, Scheurer MA, Laussen PC, Wypij D, Polito A, Bacha EA, et al. Blood transfusion after pediatric cardiac surgery is associated with prolonged hospital stay. Ann Thorac Surg 2011; 91(1): 204-10.
  7. Bigdelian H, Mardani D, Sedighi M. Comparative effects of pulmonary valve replacement (PVR) surgery with bioprosthetic and mechanical valves on early and late outcome of patients after congenital heart surgeries: 10 years of experience. Indian J Thorac Cardiovasc Surg 2014; 30(4): 257-63.
  8. Bilecen S, Peelen LM, Kalkman CJ, Spanjersberg AJ, Moons KG, Nierich AP. Fibrinogen concentrate therapy in complex cardiac surgery. J Cardiothorac Vasc Anesth 2013; 27(1): 12-7.
  9. Faraoni D, Willems A, Savan V, Demanet H, De Ville A, Van der Linden P. Plasma fibrinogen concentration is correlated with postoperative blood loss in children undergoing cardiac surgery. A retrospective review. Eur J Anaesthesiol 2014; 31(6): 317-26.
  10. Parr KG, Patel MA, Dekker R, Levin R, Glynn R, Avorn J, et al. Multivariate predictors of blood product use in cardiac surgery. J Cardiothorac Vasc Anesth 2003; 17(2): 176-81.
  11. Kozek-Langenecker SA, Afshari A, Albaladejo P, Santullano CA, De Robertis E, Filipescu DC, et al. Management of severe perioperative bleeding: Guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol 2013; 30(6): 270-382.
  12. Solomon C, Pichlmaier U, Schoechl H, Hagl C, Raymondos K, Scheinichen D, et al. Recovery of fibrinogen after administration of fibrinogen concentrate to patients with severe bleeding after cardiopulmonary bypass surgery. Br J Anaesth 2010; 104(5): 555-62.
  13. Ranucci M, Solomon C. Supplementation of fibrinogen in acquired bleeding disorders: Experience, evidence, guidelines, and licences. Br J Anaesth 2012; 109(2): 135-7.
  14. Kozek-Langenecker S, Sorensen B, Hess JR, Spahn DR. Clinical effectiveness of fresh frozen plasma compared with fibrinogen concentrate: A systematic review. Crit Care 2011; 15(5): R239.
  15. Wikkelso A, Lunde J, Johansen M, Stensballe J, Wetterslev J, Moller AM, et al. Fibrinogen concentrate in bleeding patients. Cochrane Database Syst Rev 2013; (8): CD008864.
  16. Bolliger D, Szlam F, Molinaro RJ, Rahe-Meyer N, Levy JH, Tanaka KA. Finding the optimal concentration range for fibrinogen replacement after severe haemodilution: An in vitro model. Br J Anaesth 2009; 102(6): 793-9.
  17. Solomon C, Hagl C, Rahe-Meyer N. Time course of haemostatic effects of fibrinogen concentrate administration in aortic surgery. Br J Anaesth 2013; 110(6): 947-56.
  18. Kindo M, Hoang MT, Gerelli S, Perrier S, Meyer N, Schaeffer M, et al. Plasma fibrinogen level on admission to the intensive care unit is a powerful predictor of postoperative bleeding after cardiac surgery with cardiopulmonary bypass. Thromb Res 2014; 134(2): 360-8.
  19. Montan C, Johansson F, Hedin U, Wahlgren CM. Preoperative hypofibrinogenemia is associated with increased intraoperative bleeding in ruptured abdominal aortic aneurysms. Thromb Res 2015; 135(3): 443-8.
  20. Rahe-Meyer N, Pichlmaier M, Haverich A, Solomon C, Winterhalter M, Piepenbrock S, et al. Bleeding management with fibrinogen concentrate targeting a high-normal plasma fibrinogen level: A pilot study. Br J Anaesth 2009; 102(6): 785-92.
  21. Levy JH, Goodnough LT. How I use fibrinogen replacement therapy in acquired bleeding. Blood 2015; 125(9): 1387-93.
  22. Jensen NH, Stensballe J, Afshari A. Comparing efficacy and safety of fibrinogen concentrate to cryoprecipitate in bleeding patients: A systematic review. Acta Anaesthesiol Scand 2016; 60(8): 1033-42.