Variations and obstacles in the use of coagulation factor concentrates for major trauma bleeding across Europe: outcomes from a European expert meeting

. 2022 Apr ; 48 (2) : 763-774. [epub] 20210105

Jazyk angličtina Země Německo Médium print-electronic

Typ dokumentu časopisecké články, přehledy

Perzistentní odkaz   https://www.medvik.cz/link/pmid33399876
Odkazy

PubMed 33399876
PubMed Central PMC7782571
DOI 10.1007/s00068-020-01563-2
PII: 10.1007/s00068-020-01563-2
Knihovny.cz E-zdroje

PURPOSE: Trauma is a leading cause of mortality, with major bleeding and trauma-induced coagulopathy (TIC) contributing to negative patient outcomes. Treatments for TIC include tranexamic acid (TXA), fresh frozen plasma (FFP), and coagulation factor concentrates (CFCs, e.g. prothrombin complex concentrates [PCCs] and fibrinogen concentrate [FCH]). Guidelines for TIC management vary across Europe and a clear definition of TIC is still lacking. METHODS: An advisory board involving European trauma experts was held on 02 February 2019, to discuss clinical experience in the management of trauma-related bleeding and recommendations from European guidelines, focusing on CFC use (mainly FCH). This review summarises the discussions, including TIC definitions, gaps in the guidelines that affect their implementation, and barriers to use of CFCs, with suggested solutions. RESULTS: A definition of TIC, which incorporates clinical (e.g. severe bleeding) and laboratory parameters (e.g. low fibrinogen) is suggested. TIC should be treated immediately with TXA and FCH/red blood cells; subsequently, if fibrinogen ≤ 1.5 g/L (or equivalent by viscoelastic testing), treatment with FCH, then PCC (if bleeding continues) is suggested. Fibrinogen concentrate, and not FFP, should be administered as first-line therapy for TIC. Several initiatives may improve TIC management, with improved medical education of major importance; generation of new and stronger data, simplified clinical practice guidance, and improved access to viscoelastic testing are also critical factors. CONCLUSIONS: Management of TIC is challenging. A standard definition of TIC, together with initiatives to facilitate effective CFC administration, may contribute to improved patient care and outcomes.

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World Health Organization. Violence and Injury Prevention. 2010. https://www.who.int/violence_injury_prevention/en/. Accessed 9 Mar 2020.

Haagsma JA, Graetz N, Bolliger I, Naghavi M, Higashi H, Mullany EC, et al. The global burden of injury: incidence, mortality, disability-adjusted life years and time trends from the Global Burden of Disease study 2013. Inj Prev. 2016;22:3–18. doi: 10.1136/injuryprev-2015-041616. PubMed DOI PMC

Cannon JW. Hemorrhagic Shock. N Engl J Med. 2018;378:370–379. doi: 10.1056/NEJMra1705649. PubMed DOI

Oyeniyi BT, Fox EE, Scerbo M, Tomasek JS, Wade CE, Holcomb JB. Trends in 1029 trauma deaths at a level 1 trauma center: Impact of a bleeding control bundle of care. Injury. 2017;48:5–12. doi: 10.1016/j.injury.2016.10.037. PubMed DOI PMC

Schoeneberg C, Schilling M, Hussmann B, Schmitz D, Lendemans S, Ruchholtz S. Preventable and potentially preventable deaths in severely injured patients: a retrospective analysis including patterns of errors. Eur J Trauma Emerg Surg. 2017;43:481–489. doi: 10.1007/s00068-016-0670-9. PubMed DOI

Maegele M, Lefering R, Yucel N, Tjardes T, Rixen D, Paffrath T, et al. Early coagulopathy in multiple injury: an analysis from the German Trauma Registry on 8724 patients. Injury. 2007;38:298–304. doi: 10.1016/j.injury.2006.10.003. PubMed DOI

Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003;54:1127–1130. doi: 10.1097/01.TA.0000069184.82147.06. PubMed DOI

Chang R, Cardenas JC, Wade CE, Holcomb JB. Advances in the understanding of trauma-induced coagulopathy. Blood. 2016;128:1043–1049. doi: 10.1182/blood-2016-01-636423. PubMed DOI PMC

Frith D, Goslings JC, Gaarder C, Maegele M, Cohen MJ, Allard S, et al. Definition and drivers of acute traumatic coagulopathy: clinical and experimental investigations. J Thromb Haemost. 2010;8:1919–1925. doi: 10.1111/j.1538-7836.2010.03945.x. PubMed DOI

Spahn DR, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt BJ, et al. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. Crit Care. 2019;23:98. doi:10.1186/s13054-019-2347-3. PubMed PMC

White NJ, Ward KR, Pati S, Strandenes G, Cap AP. Hemorrhagic blood failure: Oxygen debt, coagulopathy, and endothelial damage. J Trauma Acute Care Surg. 2017;82:S41–S49. doi: 10.1097/TA.0000000000001436. PubMed DOI PMC

Duque P, Mora L, Levy JH, Schochl H. Pathophysiological response to trauma-induced coagulopathy: a comprehensive review. Anesth Analg. 2020;130:654–664. doi: 10.1213/ANE.0000000000004478. PubMed DOI

MacLeod JB, Lynn M, McKenney MG, Cohn SM, Murtha M. Early coagulopathy predicts mortality in trauma. J Trauma. 2003;55:39–44. doi: 10.1097/01.ta.0000075338.21177.ef. PubMed DOI

Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, et al. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017;34:332–395. doi: 10.1097/EJA.0000000000000630. PubMed DOI

Schochl H, Voelckel W, Schlimp CJ. Management of traumatic haemorrhage--the European perspective. Anaesthesia. 2015;70 Suppl 1:102–7, e35–7. doi:10.1111/anae.12901. PubMed

Inaba K, Branco BC, Rhee P, Blackbourne LH, Holcomb JB, Teixeira PG, et al. Impact of plasma transfusion in trauma patients who do not require massive transfusion. J Am Coll Surg. 2010;210:957–965. doi: 10.1016/j.jamcollsurg.2010.01.031. PubMed DOI

Schochl H, Maegele M, Solomon C, Gorlinger K, Voelckel W. Early and individualized goal-directed therapy for trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2012;20:15. doi: 10.1186/1757-7241-20-15. PubMed DOI PMC

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. doi: 10.1016/j.ajem.2018.02.018. PubMed DOI

Innerhofer P, Fries D, Mittermayr M, Innerhofer N, von Langen D, Hell T, et al. 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. doi: 10.1016/S2352-3026(17)30077-7. PubMed DOI

Yamamoto K, Yamaguchi A, Sawano M, Matsuda M, Anan M, Inokuchi K, et al. Pre-emptive administration of fibrinogen concentrate contributes to improved prognosis in patients with severe trauma. Trauma Surg Acute Care Open. 2016;1:e000037. doi: 10.1136/tsaco-2016-000037. PubMed DOI PMC

Mengoli C, Franchini M, Marano G, Pupella S, Vaglio S, Marietta M, 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. doi: 10.2450/2017.0094-17. PubMed DOI PMC

Schafer N, Driessen A, Frohlich M, Sturmer EK, Maegele M, partners T. Diversity in clinical management and protocols for the treatment of major bleeding trauma patients across European level I Trauma Centres. Scand J Trauma Resusc Emerg Med. 2015;23:74. doi:10.1186/s13049-015-0147-6. PubMed PMC

CSL Behring. Beriplex® EU Summary of product characteristics. 2016. https://www.medicines.org.uk/emc/medicine/20797. Accessed 9 Mar 2020.

CSL Behring. Haemocomplettan® P Regional data sheet. 2019.

Octapharma AG. Fibryga® Summary of product characteristics (EU). 2019. https://www.medicines.org.uk/emc/product/10315/smpc. Accessed 9 Mar 2020.

Polytrauma Guideline Update G. Level 3 guideline on the treatment of patients with severe/multiple injuries : AWMF Register-Nr. 012/019. Eur J Trauma Emerg Surg. 2018;44:3–271. doi:10.1007/s00068-018-0922-y. PubMed PMC

Leal-Noval SR, Munoz M, Asuero M, Contreras E, Garcia-Erce JA, Llau JV, et al. Spanish Consensus Statement on alternatives to allogeneic blood transfusion: the 2013 update of the "Seville Document". Blood Transfus. 2013;11:585–610. doi: 10.2450/2013.0029-13. PubMed DOI PMC

Llau JV, Acosta FJ, Escolar G, Fernandez-Mondejar E, Guasch E, Marco P, et al. Multidisciplinary consensus document on the management of massive haemorrhage (HEMOMAS document) Med Intensiva. 2015;39:483–504. doi: 10.1016/j.medin.2015.05.002. PubMed DOI

Association of Anaesthetists of Great Britain and Ireland, Thomas D, Wee M, Clyburn P, Walker I, Brohi K, et al. Blood transfusion and the anaesthetist: management of massive haemorrhage. Anaesthesia. 2010;65:1153–61. doi:10.1111/j.1365-2044.2010.06538.x. PubMed PMC

Hunt BJ, Allard S, Keeling D, Norfolk D, Stanworth SJ, Pendry K, et al. A practical guideline for the haematological management of major haemorrhage. Br J Haematol. 2015;170:788–803. doi: 10.1111/bjh.13580. PubMed DOI

Blatný BJ, Cvachovec K, Černý V, Firment J, Kubisz P, Kvasnička J, et al. Diagnostika a léčba život ohrožujícího krvácení u dospělých pacientů v intenzivní a perioperační péči. Anesteziologie a intenzivní medicína. 2017;28:263–269.

Swedish Society on Thrombosis and Haemostasis. Hemostas vid allvarlig blödning. 2014. https://www.ssth.se/lankar. Accessed 2 March 2020.

Novak A, Stanworth SJ, Curry N. Do we still need cryoprecipitate? Cryoprecipitate and fibrinogen concentrate as treatments for major hemorrhage - how do they compare? Expert Rev Hematol. 2018;11:351–360. doi: 10.1080/17474086.2018.1458610. PubMed DOI

Chang R, Fox EE, Greene TJ, Swartz MD, DeSantis SM, Stein DM, et al. Abnormalities of laboratory coagulation tests versus clinically evident coagulopathic bleeding: results from the prehospital resuscitation on helicopters study (PROHS) Surgery. 2018;163:819–826. doi: 10.1016/j.surg.2017.10.050. PubMed DOI PMC

Peltan ID, Vande Vusse LK, Maier RV, Watkins TR. An international normalized ratio-based definition of acute traumatic coagulopathy is associated with mortality, venous thromboembolism, and multiple organ failure after injury. Critical Care Med. 2015;43:1429–1438. doi: 10.1097/CCM.0000000000000981. PubMed DOI PMC

Davenport R, Manson J, De'Ath H, Platton S, Coates A, Allard S, et al. Functional definition and characterization of acute traumatic coagulopathy. Crit Care Med. 2011;39:2652–2658. doi: 10.1097/CCM.0b013e3182281af5. PubMed DOI PMC

Hagemo JS, Christiaans SC, Stanworth SJ, Brohi K, Johansson PI, Goslings JC, 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. doi: 10.1186/s13054-015-0823-y. PubMed DOI PMC

Giordano S, Spiezia L, Campello E, Simioni P. The current understanding of trauma-induced coagulopathy (TIC): a focused review on pathophysiology. Intern Emerg Med. 2017;12:981–991. doi: 10.1007/s11739-017-1674-0. PubMed DOI

Shen L, Tabaie S, Ivascu N. Viscoelastic testing inside and beyond the operating room. J Thorac Dis. 2017;9:S299–s308. doi: 10.21037/jtd.2017.03.85. PubMed DOI PMC

Casado-Mendez M, Arellano-Orden V, Munoz-Gomez M, Rodriguez-Martorell FJ, Cayuela A, Pastor de Las Heras A, 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;29:644–50. doi:10.1097/MBC.0000000000000770. PubMed

Schochl H, Cotton B, Inaba K, Nienaber U, Fischer H, Voelckel W, et al. FIBTEM provides early prediction of massive transfusion in trauma. Crit Care. 2011;15:R265. doi: 10.1186/cc10539. PubMed DOI PMC

Nardi G, Agostini V, Rondinelli B, Russo E, Bastianini B, Bini G, et al. Trauma-induced coagulopathy: impact of the early coagulation support protocol on blood product consumption, mortality and costs. Crit Care. 2015;19:83. doi: 10.1186/s13054-015-0817-9. PubMed DOI PMC

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. doi:10.1016/S0140-6736(10)60835-5. PubMed

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;394:1713–23. doi:10.1016/S0140-6736(19)32233-0. PubMed PMC

Gayet-Ageron A, Prieto-Merino D, Ker K, Shakur H, Ageron F-X, Roberts I, et al. Effect of treatment delay on the effectiveness and safety of antifibrinolytics in acute severe haemorrhage: a meta-analysis of individual patient-level data from 40 138 bleeding patients. Lancet. 2018;391:125–132. doi: 10.1016/S0140-6736(17)32455-8. PubMed DOI PMC

Rourke C, Curry N, Khan S, Taylor R, Raza I, Davenport R, et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. J Thromb Haemost. 2012;10:1342–1351. doi: 10.1111/j.1538-7836.2012.04752.x. PubMed DOI

McQuilten ZK, Wood EM, Bailey M, Cameron PA, Cooper DJ. Fibrinogen is an independent predictor of mortality in major trauma patients: A five-year statewide cohort study. Injury. 2017;48:1074–1081. doi: 10.1016/j.injury.2016.11.021. PubMed DOI

Hagemo JS, Stanworth S, Juffermans NP, Brohi K, Cohen M, Johansson PI, et al. Prevalence, predictors and outcome of hypofibrinogenaemia in trauma: a multicentre observational study. Crit Care. 2014;18:R52. doi: 10.1186/cc13798. PubMed DOI PMC

Schlimp CJ, Voelckel W, Inaba K, Maegele M, Ponschab M, Schochl H. Estimation of plasma fibrinogen levels based on hemoglobin, base excess and Injury Severity Score upon emergency room admission. Crit Care. 2013;17:R137. doi: 10.1186/cc12816. PubMed DOI PMC

NCT01475344. Fibrinogen concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC). Manuscript under review.

Curry NS, Davenport R, Pavord S, Mallett SV, Kitchen D, Klein AA, et al. The use of viscoelastic haemostatic assays in the management of major bleeding: A British Society for Haematology Guideline. Br J Haematol. 2018;182:789–806. doi: 10.1111/bjh.15524. PubMed DOI

Caspers M, Maegele M, Frohlich M. Current strategies for hemostatic control in acute trauma hemorrhage and trauma-induced coagulopathy. Expert Rev Hematol. 2018;11:987–995. doi: 10.1080/17474086.2018.1548929. PubMed DOI

Inaba K, Rizoli S, Veigas PV, Callum J, Davenport R, Hess J, et al. 2014 Consensus conference on viscoelastic test-based transfusion guidelines for early trauma resuscitation: Report of the panel. J Trauma Acute Care Surg. 2015;78:1220–1229. doi: 10.1097/ta.0000000000000657. PubMed DOI

Gonzalez E, Moore EE, Moore HB. Management of trauma-induced coagulopathy with thrombelastography. Crit Care Clin. 2017;33:119–134. doi: 10.1016/j.ccc.2016.09.002. PubMed DOI PMC

Juffermans NP, Wirtz MR, Balvers K, Baksaas-Aasen K, van Dieren S, Gaarder C, et al. Towards patient-specific management of trauma hemorrhage: the effect of resuscitation therapy on parameters of thromboelastometry. J Thromb Haemost. 2019;17:441–448. doi: 10.1111/jth.14378. PubMed DOI PMC

Winearls J, Wullschleger M, Wake E, Hurn C, Furyk J, Ryan G, et al. Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial. Trials. 2017;18:241. doi: 10.1186/s13063-017-1980-x. PubMed DOI PMC

Ziegler B, Voelckel W, Zipperle J, Grottke O, Schöchl H. Comparison between the new fully automated viscoelastic coagulation analysers TEG 6s and ROTEM Sigma in trauma patients: A prospective observational study. Eur J Anaesthesiol. 2019;36:834–842. doi: 10.1097/eja.0000000000001032. PubMed DOI

Cardenas JC, Rahbar E, Pommerening MJ, Baer LA, Matijevic N, Cotton BA, et al. Measuring thrombin generation as a tool for predicting hemostatic potential and transfusion requirements following trauma. J Trauma Acute Care Surg. 2014;77:839–845. doi: 10.1097/TA.0000000000000348. PubMed DOI

Schochl H, Voelckel W, Maegele M, Kirchmair L, Schlimp CJ. Endogenous thrombin potential following hemostatic therapy with 4-factor prothrombin complex concentrate: a 7-day observational study of trauma patients. Crit Care. 2014;18:R147. doi: 10.1186/cc13982. PubMed DOI PMC

Zeeshan M, Hamidi M, Feinstein AJ, Gries L, Jehan F, Sakran J, et al. Four-factor prothrombin complex concentrate is associated with improved survival in trauma-related hemorrhage: A nationwide propensity-matched analysis. J Trauma Acute Care Surg. 2019;87:274–281. doi: 10.1097/TA.0000000000002262. PubMed DOI

Peralta MR, Chowdary P. The use of new procoagulants in blunt and penetrating trauma. Curr Opin Anaesthesiol. 2019;32:200–205. doi: 10.1097/ACO.0000000000000696. PubMed DOI

Dunbar NM, Chandler WL. Thrombin generation in trauma patients. Transfusion. 2009;49:2652–2660. doi: 10.1111/j.1537-2995.2009.02335.x. PubMed DOI

Hamada SR, Gauss T, Pann J, Dünser M, Leone M, Duranteau J. European trauma guideline compliance assessment: the ETRAUSS study. Critical care (London, England) 2015;19:423. doi: 10.1186/s13054-015-1092-5. PubMed DOI PMC

Royal College of Surgeons. Advanced Trauma Life Support® (ATLS®). 2019. https://www.rcseng.ac.uk/education-and-exams/courses/search/advanced-trauma-life-support-atls-provider-programme/. Accessed 28 June 2019.

HEMACRIT. Coagulopatía del paciente con HEmorragia MAsiva y CRITíca. https://hemacrit.proyectosseguros.com/. Accessed 7 January 2020.

Callum J, Farkouh ME, Scales DC, Heddle NM, Crowther M, Rao V, et al. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery: The FIBRES randomized clinical trial. JAMA. 2019:1–11. doi:10.1001/jama.2019.17312. PubMed PMC

Karkouti K, Callum J, Rao V, Heddle N, Farkouh ME, Crowther MA, et al. Protocol for a phase III, non-inferiority, randomised comparison of a new fibrinogen concentrate versus cryoprecipitate for treating acquired hypofibrinogenaemia in bleeding cardiac surgical patients: the FIBRES trial. BMJ Open. 2018;8:e020741. doi: 10.1136/bmjopen-2017-020741. PubMed DOI PMC

Okerberg CK, Williams LA, 3rd, Kilgore ML, Kim CH, Marques MB, Schwartz J, et al. Cryoprecipitate AHF vs. fibrinogen concentrates for fibrinogen replacement in acquired bleeding patients - an economic evaluation. Vox Sang. 2016;111:292–8. doi:10.1111/vox.12417. PubMed

Haas T, Spielmann N, Restin T, Schmidt AR, Schmugge M, Cushing MM. Economic aspects of intraoperative coagulation management targeting higher fibrinogen concentrations during major craniosynostosis surgery. Paediatr Anaesth. 2016;26:77–83. doi: 10.1111/pan.12784. PubMed DOI

Di Minno G, Navarro D, Perno CF, Canaro M, Gurtler L, Ironside JW, et al. Pathogen reduction/inactivation of products for the treatment of bleeding disorders: what are the processes and what should we say to patients? Ann Hematol. 2017;96:1253–1270. doi: 10.1007/s00277-017-3028-4. PubMed DOI PMC

Schlimp CJ, Ponschab M, Voelckel W, Treichl B, Maegele M, Schochl H. Fibrinogen levels in trauma patients during the first seven days after fibrinogen concentrate therapy: a retrospective study. Scand J Trauma Resusc Emerg Med. 2016;24:29. doi: 10.1186/s13049-016-0221-8. PubMed DOI PMC

Fominskiy E, Nepomniashchikh VA, Lomivorotov VV, Monaco F, Vitiello C, Zangrillo A, 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. doi: 10.1053/j.jvca.2016.04.015. PubMed DOI

Cushing MM, Haas T. Fibrinogen concentrate for perioperative bleeding: what can we learn from the clinical trials? Transfusion. 2019;59:3295–3297. doi: 10.1111/trf.15437. PubMed DOI

Solomon C, Groner A, Ye J, Pendrak I. Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data. Thromb Haemost. 2015;113:759–771. doi: 10.1160/th14-06-0514. PubMed DOI

Gratz J, Guting H, Thorn S, Brazinova A, Gorlinger K, Schafer N, et al. Protocolised thromboelastometric-guided haemostatic management in patients with traumatic brain injury: a pilot study. Anaesthesia. 2019;74:883–890. doi: 10.1111/anae.14670. PubMed DOI

LFB Biopharmaceuticals Ltd. FibCLOT® Summary of Characteristics. 2015. https://www.medicines.org.uk/emc/product/2429/smpc. Accessed 9 Mar 2020.

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