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Review

Current perspective on fibrinogen concentrate in critical bleeding

, , , &
Pages 761-778 | Received 01 Jul 2019, Accepted 28 May 2020, Published online: 17 Jul 2020

References

  • Spahn DR, Bouillon B, Cerny V, et al. The European guideline on management of major bleeding and coagulopathy following trauma. Crit Care. 2019 fifth edition;23:98.
  • Kozek-Langenecker SA, Ahmed AB, Afshari A, et al. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: first update 2016. Eur J Anaesthesiol. 2017;34:332–395.
  • Raphael J, Mazer CD, Subramani S, et al. Society of cardiovascular anesthesiologists clinical practice improvement advisory for management of perioperative bleeding and hemostasis in cardiac surgery Patients. Anesth Analg. 2019;129:1209–1221.
  • Pagano D, Milojevic M, Meesters MI, et al. EACTS/EACTA guidelines on patients blood management for adult cardiac surgery. Eur J Cardiothorac Surg. 2017;2018(53):79–111.
  • Muñoz M, Stensballe J, Duclois-Bouthors AS, et al. Patient blood management in obstetrics—prevention and treatment of postpartum haemorrhage: NATA Consensus Statement. Blood Transfus. 2019;17:112–136.
  • Curry NS, Davenport R, Pavord S, et al. The use of viscoelastic haemostatic assay in the management of major bleeding. A British society for haematology guideline. Br J Haematol. 2018;182:789–806.
  • SCGH massive transfusion protocol. Government of Western of Australia. North metropolitan health service. https://scghed.com/wp-content/uploads/2017/05/Massive-Transfusion-Protocol-2017.pdf. Accessed on December 15, 2019.
  • Leal-Noval SR, Muñoz M, Asuero M, et al. Spanish consensus statement on alternatives to allogeneic blood transfusion: the 2013 update of the “seville document”. Blood Transfus. 2013;11:585–610.
  • Sentilhes L, Vayssiere C, Deneux-Tharaux C, et al. Postpartum hemorrhage: guidelines for clinical practice from the French college of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French society of Anesthesiology and Intensive Care (SFAR). Eur J Obstet Gynecol Reprod Biol. 2016;198:12–21.
  • O´Leary JG, Grenberg CS, HEMATÍES P, et al. AGA clinical practice update: coagulation in Cirrhosis. Gastroenterology. 2019;157:34–43.
  • Collins P, Abdul-Kadir R, Thachil J. Subcommittees on women’s health issues in thrombosis and haemostatic and disseminated intravascular coagulation. Management of coagulopathy associated with postpartum hemorrhage: guidance from the SSC of the ISTH. J Thromb Haemost. 2016;14:205–210.
  • Ranucci M, Baryshnikova E, Castelvecchio S, et al. Surgical and clinical outcome research (SCORE) group. major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013;96:478–485.
  • González-Pérez A, Al-Sibai JZ, Álvarez-Fernández P, et al. Liberal red blood cell transfusion impair quality of life after cardiac surgery. Med Intensiva. 2019;43:156–164.
  • Fröhlich M, Mutschler M, Caspers M, et al. Trauma-induced coagulopathy upon emergency room arrival: still a significant problem despite increased awareness and management? Eur J Trauma Emerg Surg. 2019;45:115–124.
  • McNamara H, Kenyon C, Smith R, et al. Four years’ experience of a ROTEM®-guided algorithm for treatment of coagulopathy in obstetric haemorrhage. Anaesthesia. 2019;74:984–991.
  • Nardi G, Agostini V, Rondinelli B, et al. Trauma-induced coagulopathy: impact of the early coagulation support protocol on blood product consumption, mortality and cost. Crit Care. 2015;19:83.
  • Hunt BJ. Bleeding and coagulopathies in critical care. N Engl J Med. 2014;370:847–859.
  • Chang R, Cardenas JC, Wade CE, et al. Advances in the understanding of trauma-induced coagulopathy. Blood. 2016;128:1043–1049.
  • Kornblith LZ, Moore HB, Cohen MJ. Trauma-induced coagulopathy: the past, present, and future. J Thromb Haemost. 2019;17:852–862.
  • Gillissen A, van den Akker T, Caram-Deelder C, et al. Coagulation parameters during the course of severe postpartum hemorrhage: a nationwide retrospective cohort study. Blood Adv. 2018;2:2433–2442.
  • Charbit B, Mandelbrot L, Samain E, et al. The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost. 2007;5:266–273.
  • Gielen C, Dekkers O, Stinjnen T, et al. The effects of pre- and postoperative fibrinogen levels on blood loss after cardiac surgery: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2014;18:292–298.
  • Bouzat P, Ageron FX, Charbit J, et al. Modeling the association between fibrinogen concentration on admission and mortality in patients with massive transfusion afte severe trauma: an analysis of a large regional database. Scand J Trauma Resusc Emerg Med. 2018;26:55.
  • Mitra B, Cameron PA, Mori A, et al. Acute coagulopathy and early deaths post major trauma. Injury. 2012;43:22–25.
  • Rourke C, Curry N, Khan S, et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost. 2012;10:1342–1351.
  • Meyer DE, Vincent LE, Fox EE, et al. Every minute counts: time to delivery of initial massive transfusion cooler and its impact on mortality. J Trauma Acute Care Surg. 2017;83:19–24.
  • Dempfle CE, Kälsch T, Elmas E, et al. Impact of fibrinogen concentration in severely ill patients on mechanical properties of whole blood clots. Blood Coagul Fibrinolysis. 2008;19:565–570.
  • Borlinger D, Tanaka KA. Transfusion makeovers by Thromboelastometry—Does it work for everyone? J Cardiothorac Vasc Anesth. 2019;33:318–320.
  • Cannon JW, Longo DL. Hemorrhagic shock. N Engl J Med. 2018;378:370–379.
  • Görlinger K, Pérez-Ferrer A, Dirkmann D, et al. The role of evidence-based algorithms for rotational thromboelastometry-guided bleeding management. Korean J Anesthesiol. 2019;72:297–322.
  • Mengoli C, Franchini M, Marano G, et al. The use of fibrinogen concentrate for the management of trauma-related bleeding: a systematic review and meta-analysis. Blood Transfus. 2017;15:318–324.
  • Levy JH, Goodnough LT. How I use fibrinogen replacement therapy in acquired bleeding. Blood. 2015;125:1387–1393.
  • Ranucci M, Solomon C. Supplementation of fibrinogen in acquired bleeding disorders: experience, evidence, guidelines, and licenses. Brit J Anaesth. 2012;109:135–137.
  • Levy JH, Szlam F, Tanaka KA, et al. Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesth Analg. 2012;114:261–274.
  • Görlinger K, Dirkmann D, Hanke AA, et al. First-line therapy with coagulation factor concentrate combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery. Anesthesiology. 2011;115:1179–1191.
  • Leal-Noval SR, Casado M, Arellano-Orden V, et al. Administration of fibrinogen concentrate for refractory bleeding in massively transfused, non-trauma patients with coagulopathy: a retrospective study with comparator group. BMC Anesthesiol. 2014;14:109.
  • Veigas PV, Callum J, Rizoli S, et al. A systematic review on the rotational thrombelastometry (ROTEM®) values for the diagnosis of coagulopathy, prediction and guidance of blood transfusion and prediction of mortality in trauma patients. Scand J Trauma Resusc Emerg Med. 2016;24:114.
  • Caspers M, Maegele M, Fröhlich M. Current strategies for hemostatic control in acute trauma hemorrhage and trauma-induced coagulopathy. Expert Rev Hematol. 2018;11:987–995.
  • Sumislawski JJ, Christie SA, Kornblith LZ, et al. Discrepancies between conventional and viscoelastic assays in identifying trauma-induced coagulopathy. Am J Surg. 2019;217:1037–1041.
  • Peltan ID, Vande Vusse LK, Maier RV, et al. An International normalized ratio-based definition of acute traumatic Coagulopathy is associated with mortality, venous thromboembolism, and multiple organ failure after injury. Crit Care Med. 2015;43:1429–1438.
  • Hagemo JS, Christiaans SC, Stanworth SJ, et al. Detection of acute traumatic coagulopathy and massive transfusion requirements by means of rotational thromboelastometry: an international prospective validation study. Crit Care. 2015;19:97.
  • Davenpot R, Manson J, De’Ath H, et al. Functional definition and characterization of acute traumatic coagulopathy. Crit Care Med. 2011;39:2652–2658.
  • Fabes J, Brunskill SJ, Curry N, et al. Pro-coagulant haemostatic factors for the prevention and treatment of bleeding in people without haemophilia. Cochrane Database Syst Rev. 2018 Dec;24(12):CD010649.
  • Hiippala ST, Myllylä GJ, Vahtera EM. Hemostatic factors and replacement of major blood loss with plasma-poor red cell concentrates. Anesth Analg. 1995;81:360–365.
  • Erdoes G, Koster A, Meesters MI, et al. The role of fibrinogen and fibrinogen concentrate in cardiac surgery: an international consensus statement from the haemostatic and transfusion scientific subcommittee of the European association of cardiothoracic anaesthesiology. Anaesthesia. 2019;74:1589–1600.
  • Cortet M, Deneux-Tharaux C, Dupont C, et al. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth. 2012;108:984–989.
  • Higgins N, Patel SK, Toledo P. Postpartum hemorrhage: new challenges and solutions. Curr Opin Anaesthesiol. 2019;32:278–284.
  • Gillisen A, van den Akker T, Caram-Deelder C, et al. Comparison of thromboelastometry by ROTEM® Delta and ROTEM® Sigma in women with postpartum haemorrhage. Scand J Clin Lab Invest. 2019;79:32–38.
  • Toffaleti JG, Buckner KA. Use of earlier-reported rotational thromboelastometry parameters to evaluate clotting status, fibrinogen and platelet activities in postpartum hemorrhage compared to surgery and intensive care patients. Anesth Analg. 2019;128:414–423.
  • Agarwal S, Johnson RI, Shaw M. A comparison of fibrinogen measurement using TEG® functional fibrinogen and Clauss in cardiac surgery patients. Int J Lab Hematol. 2015;37:459–465.
  • Leal-Noval SR, Fernández-Pacheco J, Casado- Méndez M, et al. A prospective study on the correlation between thromboelastometry and conventional laboratory clotting parameters in surgical patients: influence of type of surgery and perioperative sampling times. Scand J Clin Lab Invest. 2019. DOI:10.1080/00365513.2019.1704051.
  • Pérez-Ferrer A, Vicente -Sánchez J, Carceles-Baron MD, et al. Early thromboelastometry variables predict maximum clot firmness in children undergoing cardiac and non-cardiac surgery. Br J Anaesth. 2015;115:896–902.
  • Seebold JA, Campbell D, Wake E, et al. Targeted fibrinogen concentrate use in severe traumatic haemorrhage. Crit Care Resusc. 2019;21:171–178.
  • Stanworth SJ, Walsh TS, Prescot RJ, et al. Intensive Care study of coagulopathy (ISOC) investigators. A national survey of plasma use in critical care: clinical indications, dose and effect on prothrombin time. Crit Care. 2011;15:R108.
  • Khan S, Davenport R, Raza I, et al. Damage control resuscitation using blood components therapy in standard doses has a limited effect on coagulopathy during trauma hemorrhage. Intensive Care Med. 2015;41:239–247.
  • Nascimento B, Goodnough LT, Levy JH. Cryoprecipitate therapy. Br J Anaesth. 2014;113:922–934.
  • Sugiyama K, Fujita H, Nishimura S. Effects of in-house cryoprecipitate on transfusion usage and mortality in patients with multiple trauma with severe traumatic brain injury: a retrospective cohort study. Blood Transfus. 2020;18:6–12.
  • Wong N, Curry N. Do we need cryoprecipitate in the era of fibrinogen concentrate and other specific factor replacement options? ISBT Sci Ser. 2018;13:23–28.
  • Holcomb JB, Fox EE, Zhang X, et al. Cryoprecipitate use in the PROMMTT study. J Trauma Acute Care Surg. 2013;75(1 Suppl):S31–S39. .
  • Riastap. CSL Behring website. https://labeling.cslbehring.com/PI/US/Riastap/EN/RiaSTAP-Prescribing-Information.pdf. Published April 2019. Accesed Dec 2019.
  • Ashok R, Sargant N, Rangarajan S, et al. Fibrinogen concentrate vs cryoprecipitate in pseudomyxoma peritonei surgery: interim results from a prospective, randomized, controlled phase 2 Study. Blood. 2018;132:2549.
  • Callum J, Farkouh ME, Scales DC, et al. Effect of Fibrinogen Concentrate vs Cryoprecipitate on blood component transfusion after cardiac surgery. The fibres randomized clinical trial. JAMA. 2019;322:1966–1976.
  • Hess AS, Hess JR, Coursin DB. Should fibrinogen concentrate replace cryoprecipitate in cardiac surgery? JAMA. 2019;322:1958–1960.
  • Gorlinger K, Fries D, Dirkmann D, et al. Reduction of fresh frozen plasma requirements by perioperative point-of-care coagulation management with early calculated goal-directed therapy. Transfus Med Hemother. 2012;39:104–113.
  • American College of Surgeons. Trauma quality improvement program. Massive transfusion in trauma 2018; https://www.facs.org/~/media/files/quality%20programs/trauma/tqip/transfusion_guildelines.ashx. Accessed on 2019 Dec 20.
  • Curry N, Foley C, Wong H, et al. Early fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multi-centre, randomised, double blind, placebo-controlled pilot trial. Crit Care. 2018;22:164.
  • Winearls J, Wullschleger M, Wake E, et al. Fibrinogen early in severe trauma studY (FEISTY): study protocol for a randomised controlled trial. Trials. 2017;18(1):241.. d. .
  • Shakur H, Roberts I, Bautista R, et al. CRASH-2. trial collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010;376:23–32.
  • WOMAN Trial collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with postpartum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017;389:2105–2116.
  • CRASH-3 trial collaborators. Effects of tranexamic acid on death, disability, vascular occlusive events and other morbidities in patients with acute traumatic brain injury (CRASH-3): a randomised, placebo-controlled trial. Lancet. 2019;394:1713–1723.
  • Abuelkasem E, Lu S, Tanaka K, et al. Comparison between thromboelastography and thromboelastometry in hyperfibrinolysis detection during adult liver transplantation. Br J Anaesth. 2016;116:507–512.
  • Harr JN, Moore EE, Chin TL, et al. Viscoelastic hemostatic fibrinogen assays detect fibrinolysis early. Eur J Trauma Emerg Surg. 2015;41:49–56.
  • Morrison GA, Koch J, Royds M, et al. Fibrinogen concentrate vs. Fresh frozen plasma for the management of coagulopathy during thoraco-abdominal aortic aneurysm surgery: a pilot randomised controlled trial. Anaesthesia. 2019;74:180–189.
  • Fahrendorff M, Oliveri RS, Johansson PI. The use of viscoelastic haemostatic assays in goal-directing treatment with allogeneic blood products. A systematic review and meta-analysis. Scand J Trauma Resusc Emerg Med. 2017;25:39.
  • Gonzalez E, Moore EE, Moore HB, et al. Goal-directed hemostatic resuscitation of trauma-induced coagulopathy a pragmatic randomized clinical trial comparing a viscoelastic assay to conventional coagulation assays. Ann Surg. 2016;263:1051–1059.
  • Wikkelso A, Wetterslev J, Moller AM, et al. Thromboelastography (TEG) or thromboelastometry (ROTEM®) to monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database Syst Rev. 2016;22:CD007871.
  • Drumheller BC, Stein DM, Moore LJ, et al. Thromboelastography and rotational thromboelastometry for the surgical intensivist: A narrative review. J Trauma Acute Care Surg. 2019;86:710–721.
  • Dias JD, Sauaia A, Achneck HE, et al. Thromboelastography-guided therapy improves patient blood management and certain clinical outcomes in elective cardiac and liver surgery and emergency resuscitation: a systematic review and analysis. J Thromb Haemost. 2019;17:984–994.
  • Lodewyks C, Heinrichs J, Grocott HP, et al. Point-of-care viscoelastic hemostatic testing in cardiac surgery patients: a systematic review and meta-analysis. Can J Anaesthe. 2018;65:1333.1347.
  • Zamper RPC, Amorim TC, Queiroz VNF, et al. Association between viscoelastic tests-guided therapy with synthetic factor concentrates and allogenic blood transfusion in liver transplantation: a before-after study. BMC Anesthesiol. 2018;18:198.
  • Redfern RE, Fleming K, March RL, et al. Thrombelastography directed transfusion in cardiac surgery: impact on postoperative outcomes. Ann Thorac Surg. 2019;107:1313–1318.
  • Holcomb JB, Del Junco DJ, Fox EE, et al. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013;148:127–136.
  • Holcomb JB, Tilley BC, Baraniuk S, et al. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015;313:471–482.
  • Schlimp CJ, Voelckel W, Inaba K, et al. Estimation of plasma fibrinogen levels based on hemoglobin, base excess and Injury Severity Score upon emergency room admission. Crit Care. 2013;17:R137.
  • Hagemo JS, Stanworth S, Juffermans NP, et al. Prevalence, predictors and outcome of hypofibrinogenaemia in trauma: a multicentre observational study. Crit Care. 2014;18:R52.
  • Gratz J, Güting H, Thorn S, et al. Protocolised thromboelastometric-guided haemostatic management in patients with traumatic brain injury: a pilot study. Anaesthesia. 2019;74:883–890.
  • Chico Fernández M, Mudarra Reche C. Traumatic coagulopathies. Med Intensiva. 2019;43:497–499.
  • Davenport RA, Guerreiro M, Frith D, et al. Activated protein c drives the hyperfibrinolysis of acute traumatic coagulopathy. Anesthesiology. 2017;126:115–127.
  • Niles SE, McLaughlin DF, Perkins JG, et al. Increased mortality associated with the early coagulopathy of trauma in combat casualties. J Trauma. 2008;64:1459–1465.
  • Schöchl H, Cotton B, Inaba K, et al. FIBTEM provides early prediction of massive transfusion in trauma. Crit Care. 2011;15:R265.
  • Baksaas-Aasen K, Van Dieren S, Balvers K, et al. TACTIC/INTRN collaborators. Data-driven development of ROTEM and TEG algorithms for the management of trauma hemorrhage: a prospective observational multicenter study. Ann Surg. 2019;270:1178–1185.
  • Chang R, Kerby JD, Kalkwarf KJ, et al. Earlier time to hemostasis is associated with decreased mortality and rate of complications: results from the pragmatic randomized optimal platelet and plasma ratio trial. J Trauma Acute Care Surg. 2019;87:342–349.
  • Inaba K, Branco BC, Rhee P, et al. Impact of plasma transfusion in trauma patients who do not require massive transfusion. J Am Coll Surg. 2010;210:957–965.
  • Peng HT, Nascimento B, Tien H, et al. A comparative study of viscoelastic hemostatic assays and conventional coagulation tests in trauma patients receiving fibrinogen concentrate. Clin Chim Acta. 2019;495:253–262.
  • Innerhofer P, Fries D, Mittermayr M. Reversal of trauma-induced coagulopathy using first-line coagulation factor concentrates or fresh frozen plasma (RETIC): a single-centre, parallel-group, open-label, randomised trial. Lancet Haematol. 2017;4:e258–e271.
  • Gonzalez EA, Moore FA, Holcomb JB, et al. Fresh frozen plasma should be given earlier to patients requiring massive transfusion. J Trauma. 2007;62:112–119.
  • Inokuchi K, Sawano M, Yamamoto K, et al. Early administration of fibrinogen concentrates improves the short-term outcomes of severe pelvic fracture patients. Acute Med Surg. 2017;4:271–277.
  • Curry N, Rourke C, Davenport R, et al. Early cryoprecipitate for major haemorrhage in trauma: a randomised controlled feasibility trial. Br J Anaesth. 2015;115:76–83.
  • Marsden M, Benger J, Brohi K, et al. CRYOSTAT-2 investigators. Coagulopathy, cryoprecipitate and CRYOSTAT-2: realising the potential of a nation wide trauma system for a national clinical trial. Br J Anaesth. 2019;122:164–169.
  • Rahouma M, Kamel M, Jodeh D, et al. Does a balanced transfusion ratio of plasma to packed red blood cells improve outcomes in both trauma and surgical patients? A meta-analysis of randomized controlled trials and observational studies. Am J Surg. 2018;216:342–350.
  • Sihler KC, Napolitano LM. Complications of massive transfusion. Chest. 2010;137:209–220.
  • Terceros-Almanza LJ, García-Fuentes C, Bermejo-Aznárez S, et al. Prediction of massive bleeding in a prehospital setting: validation of six scoring systems. Med Intensiva. 2019;43:131–138.
  • Nardi G, Agostini V, Rondinelli BM, et al. Prevention and treatment of trauma induced coagulopathy (TIC). An intended protocol from the Italian trauma update research group. J Anesthesiol Clini Sci. 2013;2:22.
  • Akbari E, Safari S, Hatamabadi H. The effect of fibrinogen concentrate and fresh frozen plasma on the outcome of patients with acute traumatic coagulopathy: a quasi-experimental study. Am J Emerg Med. 2018;36:1947–1950.
  • Hanke AA, Horstmann H, Wilhelmi M. Point-of-care monitoring for the management of trauma-induced bleeding. Curr Opin Anesthesiol. 2017;30:250–256.
  • Mesar T, Larentzakis A, Dzik Y, et al. Association between ratio of fresh frozen plasma to red blood cells during massive transfusion and survival among patients without traumatic injury. JAMA Surg. 2017;152:574–580.
  • Thomasson RR, Yazer MH, Gorham JD, et al. On behalf of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative International assessment of massive transfusion protocol contents and indications for activation. Transfusion. 2019;59:1637–1643.
  • 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;117:531–547.
  • 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 Cardiothoracic Vas Anesth. 2019;33:307–317.
  • Haensig M, Kempfert J, Kempfert PM, et al. Thrombelastometry guided blood-component therapy after cardiac surgery: a randomized study. BMC Anesthesiol. 2019;19:201.
  • Scolletta S, Simioni P, Campagnolo V, et al. Patient blood management in cardiac surgery: the “Granducato algorithm”. Int J Cardiol. 2019;289:37–42.
  • 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;203:424–433.
  • Serraino GF, Murphy GJ. Routine use of viscoelastic blood tests for diagnosis and treatment of coagulopathic bleeding in cardiac surgery: updated systematic review and meta-analysis. Br J Anaesth. 2017;118:823–833.
  • Wikkelso A, Lunde J, Johansen M, et al. Fibrinogen concentrate in bleeding Patients. Cochrane Database Rev. 2013;8:CD008864. DOI:10.1002/14651858.CD008864.pub2.
  • Li JY, Gong J, Zhu F, et al. Fibrinogen concentrate in cardiovascular surgery: a meta-analysis of randomized controlled trials. Anesth Analg. 2018;127:612–621.
  • Lancé MD, Ninivaggi M, Schols SE, et al. Perioperative dilutional coagulopathy treated with fresh frozen plasma and fibrinogen concentrate: a prospective randomized intervention trial. Vox Sang. 2012;103:25–34.
  • Rahe-Meyer N, Solomon C, Henke A. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery. Anesthesiology. 2013;118:40–50.
  • Sadeghi M, Atefyekta R, Azimaraghi O. A randomized, double blind trial of prophylactic fibrinogen to reduce bleeding in cardiac surgery. Rev Bras Anestesiol. 2014;64:253–257.
  • Ranucci M, Baryshnikova E, Crapelli GB, et al. Randomized, double blinded, placebo controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery. J Am Heart Assoc. 2015;4:e002066.
  • Rahe-Meyer N, Levy JH, Mazer CD. Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy. Br J Anesth. 2016;117:41–51.
  • Jeppsson A, Waldén K, Roman-Emanuel C. Preoperative supplementation with fibrinogen concentrate in cardiac surgery: a randomized controlled study. Br J Anesth. 2016;116:208–214.
  • Bilecen S, Groot JAH, Kalkman CR. Effect of fibrinogen concentrate on intraoperative blood loss among patients with intraoperative bleeding during high-risk cardiac surgery. JAMA. 2017;317:738–747.
  • Kwapisz MM, Kent B, DiQuinzio C, et al. The prophylactic use of fibrinogen concentrate in high-risk cardiac surgery. Acta Anesthesiol Scand. 2020;64:602–612.
  • Rahe-Meyer N, Levy JH, Mazer CD, et al. Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery: post hoc analysis and interpretation of phase III results. Interact Cardiovasc Thorac Surg. 2019;28:566–574.
  • Szecsi PB, Jorgensen M, Klajnbard A, et al. Haemostatic reference intervals in pregnancy. Thromb Haemost. 2010;103:718–727.
  • Lee J, Eley VA, Wyssusek KH, et al. Baseline parameters for rotational thromboelastometry (ROTEM® ®) in healthy women undergoing elective caesarean delivery: a prospective observational study in Australia. Int J Obstet Anesth. 2019;38:10–18.
  • Armstrong S, Fernando R, Ashpole K, et al. Assessment of coagulation in the obstetric population using ROTEM® thromboelastometry. Int J Obstet Anesth. 2011;20:293–298.
  • de Lange NM, van Rheenen-flach LE, Lancé MD, et al. Peri-partum reference ranges for ROTEM thromboelastometry. Br J Anaesth. 2014;112:852–859.
  • Lee J, Eley VA, Wyssusek KH, et al. Baseline parameters for rotational thromboelastometry in healthy laboring women: a prospective observational study. BJOG. 2020;127:820–827.
  • Huissoud C, Carrabin N, Auidebert F, et al. Bedside assessment of fibrinogen level in postpartum haemorrhage by thromboelastometry. BJOG. 2009;116:1097–1102.
  • Collins PW, Lilley G, Bruynseels D, et al. Fibrin-based clot formation as an early and rapid biomarker for progression of postpartum hemorrhage: a prospective study. Blood. 2014;124:1727–1736.
  • Collins PW, Bell SF, de Lloyd L, et al. Management of postpartum haemorrhage: from research into practice, a narrative review of the literature and the cardiff experience. Int J Obstet Anesth. 2019;37:106–117.
  • Snegovskikh D, Sousa D, Walton Z, et al. Point-of-care viscoelastic testing improves the outcome of pregnancies complicated by severe postpartum hemorrhage. J Clin Anesth. 2018;44:50–56.
  • Wikkelso AJ, Edwards HM, Afshari A, et al. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial. Br J Anaesth. 2015;114:623–633.
  • Collins PW, Cannings-John R, Bruynseels D, et al. Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial. Br J Anaesth. 2017;119:411–421.
  • Lisman T, Porte RJ. Rebalanced hemostasis in patients with liver disease: evidence and clinical consequences. Blood. 2010;116:878–885.
  • Döstch TM, Dirkmann D, Bezinover D, et al. Assessment of standard laboratory tests and rotational thromboelastometry for the prediction of postoperative bleeding in liver transplantation. Br J Anaesth. 2017;119:402–410.
  • Blaine KP, Sakai T. Viscoelastic monitoring to guide hemostatic resuscitation in liver transplantation surgery. Semin Cardiothor Vasc Anesth. 2018;22:150–163.
  • Schumacher C, Eismann H, Sieg L, et al. Use of rotational thromboelastometry in liver transplantation is associated with reduced transfusion requirement. Exp Clin Transplant. 2019;17:222–230.
  • Bonnet A, Gilquin N, Steer N, et al. The use of a thromboelastometry based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation. A randomised controlled study. Eur J Anaesthesiol. 2019;36:825–833.
  • Sabate A, Gutiérrez R, Beltran J. Impact of preemptive fibrinogen concentrate on transfusion requirement in liver transplantation: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Transplant. 2016;16:2421–2429.
  • Fenger-Eriksen C, Jensen TM, Kristesen TM, et al. Fibrinogen substitution 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.
  • Soleimani M, Masoumi N, Nooraei N. The effect of fibrinogen concentrate on perioperative bleeding in transurethral resection of the prostate: a double-blind placebo-controlled and randomized study. J Thromb Haemost. 2016;15:255–262.
  • Fominsky E, Nepomniashchikh VA, Lomivorotov VV. Efficacy and Safety of fibrinogen concentrate in surgical patients: A meta-analysis of randomized controlled trials. J Cardioth Vasc Anest. 2016;30:1196–1204.
  • Stein AL, Rössler J, Braun J, et al. Impact of a goal-directed factor-based coagulation management on thromboembolic events following major trauma. Scand J Trauma Resusc Emerg Med. 2019;30:117.
  • Silva Aycaguer LC. Frequent methodological errors in clinical research. Med Intensiva. 2018;42:541–546.
  • García Garmendia JL. Evaluation and closure of the series on methodology in Intensive Care Medicine. Med Intensiva. 2019;43:121–123.
  • García Garmendia JL, Moroto Monserrat F. Interpretation of statistical results. Med Intensiva. 2018;42:370–379.
  • Cushing MM, Haas T. Fibrinogen concentrate for perioperative bleeding: what can we learn from the clinical trials? Transfusion. 2019;59:3295–3297.
  • Fries DA. Multicenter Double-blind, Placebo Controlled, Randomized, Pilot Trial to Assess the Efficacy of Pre-hospital Administration of Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC). https://clinicaltrials.gov/ct2/show/record/NCT01475344
  • Casado-Méndez M, Arellano-Orden V, Rodríguez-Martorell FJ, et al. Reliability of the portable coagulometer qLabs to accurately measure the activated thromboplastin time and international normalized ratio: a prospective study in critically ill patients. Blood Coagul Fibrinolysis. 2018;29:644–650.

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