Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Critical Care
Published in: Critical Care 2/2010

Open Access 01-04-2010 | Research

Goal-directed coagulation management of major trauma patients using thromboelastometry (ROTEM®)-guided administration of fibrinogen concentrate and prothrombin complex concentrate

Authors: Herbert Schöchl, Ulrike Nienaber, Georg Hofer, Wolfgang Voelckel, Csilla Jambor, Gisela Scharbert, Sibylle Kozek-Langenecker, Cristina Solomon

Published in: Critical Care | Issue 2/2010

Login to get access

Abstract

Introduction

The appropriate strategy for trauma-induced coagulopathy management is under debate. We report the treatment of major trauma using mainly coagulation factor concentrates.

Methods

This retrospective analysis included trauma patients who received ≥ 5 units of red blood cell concentrate within 24 hours. Coagulation management was guided by thromboelastometry (ROTEM®). Fibrinogen concentrate was given as first-line haemostatic therapy when maximum clot firmness (MCF) measured by FibTEM (fibrin-based test) was <10 mm. Prothrombin complex concentrate (PCC) was given in case of recent coumarin intake or clotting time measured by extrinsic activation test (EXTEM) >1.5 times normal. Lack of improvement in EXTEM MCF after fibrinogen concentrate administration was an indication for platelet concentrate. The observed mortality was compared with the mortality predicted by the trauma injury severity score (TRISS) and by the revised injury severity classification (RISC) score.

Results

Of 131 patients included, 128 received fibrinogen concentrate as first-line therapy, 98 additionally received PCC, while 3 patients with recent coumarin intake received only PCC. Twelve patients received FFP and 29 received platelet concentrate. The observed mortality was 24.4%, lower than the TRISS mortality of 33.7% (P = 0.032) and the RISC mortality of 28.7% (P > 0.05). After excluding 17 patients with traumatic brain injury, the difference in mortality was 14% observed versus 27.8% predicted by TRISS (P = 0.0018) and 24.3% predicted by RISC (P = 0.014).

Conclusions

ROTEM®-guided haemostatic therapy, with fibrinogen concentrate as first-line haemostatic therapy and additional PCC, was goal-directed and fast. A favourable survival rate was observed. Prospective, randomized trials to investigate this therapeutic alternative further appear warranted.
Appendix
Available only for authorised users
Literature
1.
Brohi K, Singh J, Heron M, Coats T: Acute traumatic coagulopathy. J Trauma 2003, 54: 1127-1130. 10.1097/01.TA.0000069184.82147.06CrossRefPubMed
2.
Maegele M, Lefering R, Yucel N, Tjardes T, Rixen D, Paffrath T, Simanski C, Neugebauer E, Bouillon B: Early coagulopathy in multiple injury: an analysis from the German Trauma Registry on 8724 patients. Injury 2007, 38: 298-304. 10.1016/j.injury.2006.10.003CrossRefPubMed
3.
Spahn DR, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, Gordini G, Stahel PF, Hunt BJ, Komadina R, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R: Management of bleeding following major trauma: a European guideline. Crit Care 2007, 11: R17. 10.1186/cc5686PubMedCentralCrossRefPubMed
4.
Stainsby D, MacLennan S, Thomas D, Isaac J, Hamilton PJ: Guidelines on the management of massive blood loss. Br J Haematol 2006, 135: 634-641. 10.1111/j.1365-2141.2006.06355.xCrossRefPubMed
5.
Stanworth SJ, Hyde CJ, Murphy MF: Evidence for indications of fresh frozen plasma. Transfus Clin Biol 2007, 14: 551-556. 10.1016/j.tracli.2008.03.008CrossRefPubMed
6.
Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB: The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma 2007, 63: 805-813. 10.1097/TA.0b013e3181271ba3CrossRefPubMed
7.
Gunter OL Jr, Au BK, Isbell JM, Mowery NT, Young PP, Cotton BA: Optimizing outcomes in damage control resuscitation: identifying blood product ratios associated with improved survival. J Trauma 2008, 65: 527-534. 10.1097/TA.0b013e3181826ddfCrossRefPubMed
8.
Hess JR, Dutton RB, Holcomb JB, Scalea TM: Giving plasma at a 1:1 ratio with red cells in resuscitation: who might benefit? Transfusion 2008, 48: 1763-1765. 10.1111/j.1537-2995.2008.01743.xCrossRefPubMed
9.
Kashuk JL, Moore EE, Johnson JL, Haenel J, Wilson M, Moore JB, Cothren CC, Biffl WL, Banerjee A, Sauaia A: Postinjury life threatening coagulopathy: is 1:1 fresh frozen plasma:packed red blood cells the answer? J Trauma 2008, 65: 261-270. 10.1097/TA.0b013e31817de3e1CrossRefPubMed
10.
Maegele M, Lefering R, Paffrath T, Tjardes T, Simanski C, Bouillon B: Red-blood-cell to plasma ratios transfused during massive transfusion are associated with mortality in severe multiple injury: a retrospective analysis from the Trauma Registry of the Deutsche Gesellschaft fur Unfallchirurgie. Vox Sang 2008, 95: 112-119. 10.1111/j.1423-0410.2008.01074.xCrossRefPubMed
11.
Scalea TM, Bochicchio KM, Lumpkins K, Hess JR, Dutton R, Pyle A, Bochicchio GV: Early aggressive use of fresh frozen plasma does not improve outcome in critically injured trauma patients. Ann Surg 2008, 248: 578-584.PubMed
12.
Sperry JL, Ochoa JB, Gunn SR, Alarcon LH, Minei JP, Cuschieri J, Rosengart MR, Maier RV, Billiar TR, Peitzman AB, Moore EE: An FFP:PRBC transfusion ratio >/= 1:1.5 is associated with a lower risk of mortality after massive transfusion. J Trauma 2008, 65: 986-993. 10.1097/TA.0b013e3181878028CrossRefPubMed
13.
Spinella PC, Perkins JG, Grathwohl KW, Beekley AC, Niles SE, McLaughlin DF, Wade CE, Holcomb JB: Effect of plasma and red blood cell transfusions on survival in patients with combat related traumatic injuries. J Trauma 2008, 64: S69-77. 10.1097/TA.0b013e318160ba2fCrossRefPubMed
14.
Teixeira PG, Inaba K, Shulman I, Salim A, Demetriades D, Brown C, Browder T, Green D, Rhee P: Impact of plasma transfusion in massively transfused trauma patients. J Trauma 2009, 66: 693-697. 10.1097/TA.0b013e31817e5c77CrossRefPubMed
15.
Chaiwat O, Lang JD, Vavilala MS, Wang J, MacKenzie EJ, Jurkovich GJ, Rivara FP: Early packed red blood cell transfusion and acute respiratory distress syndrome after trauma. Anesthesiology 2009, 110: 351-360. 10.1097/ALN.0b013e3181948a97CrossRefPubMed
16.
Sarani B, Dunkman WJ, Dean L, Sonnad S, Rohrbach JI, Gracias VH: Transfusion of fresh frozen plasma in critically ill surgical patients is associated with an increased risk of infection. Crit Care Med 2008, 36: 1114-1118. 10.1097/CCM.0b013e318168f89dCrossRefPubMed
17.
18.
Stainsby D, Jones H, Asher D, Atterbury C, Boncinelli A, Brant L, Chapman CE, Davison K, Gerrard R, Gray A, Knowles S, Love EM, Milkins C, McClelland DB, Norfolk DR, Soldan K, Taylor C, Revill J, Williamson LM, Cohen H: Serious hazards of transfusion: a decade of hemovigilance in the UK. Transfus Med Rev 2006, 20: 273-282. 10.1016/j.tmrv.2006.05.002CrossRefPubMed
19.
Stinger HK, Spinella PC, Perkins JG, Grathwohl KW, Salinas J, Martini WZ, Hess JR, Dubick MA, Simon CD, Beekley AC, Wolf SE, Wade CE, Holcomb JB: The ratio of fibrinogen to red cells transfused affects survival in casualties receiving massive transfusions at an army combat support hospital. J Trauma 2008, 64: S79-85. 10.1097/TA.0b013e318160a57bCrossRefPubMed
20.
Danes AF, Cuenca LG, Bueno SR, Mendarte Barrenechea L, Ronsano JB: 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: 221-226. 10.1111/j.1423-0410.2007.01024.xCrossRefPubMed
21.
Fenger-Eriksen C, Lindberg-Larsen M, Christensen AQ, Ingerslev J, Sorensen B: Fibrinogen concentrate substitution therapy in patients with massive haemorrhage and low plasma fibrinogen concentrations. Br J Anaesth 2008, 101: 769-773. 10.1093/bja/aen270CrossRefPubMed
22.
Bruce D, Nokes TJ: Prothrombin complex concentrate (Beriplex P/N) in severe bleeding: experience in a large tertiary hospital. Crit Care 2008, 12: R105. 10.1186/cc6987PubMedCentralCrossRefPubMed
23.
Schick KS, Fertmann JM, Jauch KW, Hoffmann JN: Prothrombin complex concentrate in surgical patients: retrospective evaluation of vitamin K antagonist reversal and treatment of severe bleeding. Crit Care 2009, 13: R191. 10.1186/cc8186PubMedCentralCrossRefPubMed
24.
Ganter MT, Hofer CK: Coagulation monitoring: current techniques and clinical use of viscoelastic point-of-care coagulation devices. Anesth Analg 2008, 106: 1366-1375. 10.1213/ane.0b013e318168b367CrossRefPubMed
25.
Kaufmann CR, Dwyer KM, Crews JD, Dols SJ, Trask AL: Usefulness of thrombelastography in assessment of trauma patient coagulation. J Trauma 1997, 42: 716-720. 10.1097/00005373-199704000-00023CrossRefPubMed
26.
Rugeri L, Levrat A, David JS, Delecroix E, Floccard B, Gros A, Allaouchiche B, Negrier C: Diagnosis of early coagulation abnormalities in trauma patients by rotation thrombelastography. J Thromb Haemost 2007, 5: 289-295. 10.1111/j.1538-7836.2007.02319.xCrossRefPubMed
27.
Lang T, Bauters A, Braun SL, Potzsch B, von Pape KW, Kolde HJ, Lakner M: Multi-centre investigation on reference ranges for ROTEM thromboelastometry. Blood Coagul Fibrinolysis 2005, 16: 301-310. 10.1097/01.mbc.0000169225.31173.19CrossRefPubMed
28.
Davis EG, MacKenzie EJ, Sacco WJ, Bain LW Jr, Buckman RF Jr, Champion HR, Lees PS: A new "TRISS-like" probability of survival model for intubated trauma patients. J Trauma 2003, 55: 53-61. 10.1097/01.TA.0000075340.22097.B5CrossRefPubMed
29.
Lefering R: Development and validation of the revised injury severity classification score for severely injured patients. Eur J Trauma Emerg Surg 2009, 35: 437-447. 10.1007/s00068-009-9122-0CrossRef
30.
Fries D, Haas T, Klingler A, Streif W, Klima G, Martini J, Wagner-Berger H, Innerhofer P: Efficacy of fibrinogen and prothrombin complex concentrate used to reverse dilutional coagulopathy--a porcine model. Br J Anaesth 2006, 97: 460-467. 10.1093/bja/ael191CrossRefPubMed
31.
Haas T, Fries D, Velik-Salchner C, Oswald E, Innerhofer P: Fibrinogen in craniosynostosis surgery. Anesth Analg 2008, 106: 725-731. 10.1213/ane.0b013e318163fb26CrossRefPubMed
32.
Nielsen VG, Levy JH: Fibrinogen and bleeding: old molecule--new ideas. Anesth Analg 2007, 105: 902-903. 10.1213/01.ane.0000286775.33975.6eCrossRefPubMed
33.
Rahe-Meyer N, Pichlmaier M, Haverich A, Solomon C, Winterhalter M, Piepenbrock S, Tanaka KA: Bleeding management with fibrinogen concentrate targeting a high-normal plasma fibrinogen level: a pilot study. Br J Anaesth 2009, 102: 785-792. 10.1093/bja/aep089PubMedCentralCrossRefPubMed
34.
Hiippala ST, Myllyla GJ, Vahtera EM: Hemostatic factors and replacement of major blood loss with plasma-poor red cell concentrates. Anesth Analg 1995, 81: 360-365. 10.1097/00000539-199508000-00026PubMed
35.
Lampl L, Seifried E, Tisch M, Helm M, Maier B, Bock KH: [Hemostatic disorders following polytrauma--the role of physiologic coagulation inhibitors during the preclinical phase]. Anasthesiol Intensivmed Notfallmed Schmerzther 1992, 27: 31-36. 10.1055/s-2007-1000248CrossRefPubMed
36.
Plotkin AJ, Wade CE, Jenkins DH, Smith KA, Noe JC, Park MS, Perkins JG, Holcomb JB: A reduction in clot formation rate and strength assessed by thrombelastography is indicative of transfusion requirements in patients with penetrating injuries. J Trauma 2008, 64: S64-68. 10.1097/TA.0b013e318160772dCrossRefPubMed
37.
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: 793-799. 10.1093/bja/aep098CrossRefPubMed
38.
Mosesson MW: Antithrombin I. Inhibition of thrombin generation in plasma by fibrin formation. Thromb Haemost 2003, 89: 9-12.PubMed
39.
Sniecinski RM, Chen EP, Tanaka KA: Reduced levels of fibrin (antithrombin I) and antithrombin III underlie coagulopathy following complex cardiac surgery. Blood Coagul Fibrinolysis 2008, 19: 178-179. 10.1097/MBC.0b013e3282f40d4aCrossRefPubMed
40.
Dickneite G, Pragst I, Joch C, Bergman GE: Animal model and clinical evidence indicating low thrombogenic potential of fibrinogen concentrate (Haemocomplettan P). Blood Coagul Fibrinolysis 2009, in press. 10.1097/MBC.0b013e32832da1c5
41.
Lang T, Johanning K, Metzler H, Piepenbrock S, Solomon C, Rahe-Meyer N, Tanaka KA: The effects of fibrinogen levels on thromboelastometric variables in the presence of thrombocytopenia. Anesth Analg 2009, 108: 751-758. 10.1213/ane.0b013e3181966675CrossRefPubMed
42.
Velik-Salchner C, Haas T, Innerhofer P, Streif W, Nussbaumer W, Klingler A, Klima G, Martinowitz U, Fries D: The effect of fibrinogen concentrate on thrombocytopenia. J Thromb Haemost 2007, 5: 1019-1025. 10.1111/j.1538-7836.2007.02481.xCrossRefPubMed
43.
Fenger-Eriksen C, Tonnesen E, Ingerslev J, Sorensen B: Mechanisms of hydroxyethyl starch-induced dilutional coagulopathy. J Thromb Haemost 2009, 7: 1099-1105. 10.1111/j.1538-7836.2009.03460.xCrossRefPubMed
44.
Schöchl H: Coagulation management in major trauma. Hamostaseologie 2006, 26: S52-55.PubMed
45.
Chowdhury P, Saayman AG, Paulus U, Findlay GP, Collins PW: Efficacy of standard dose and 30 ml/kg fresh frozen plasma in correcting laboratory parameters of haemostasis in critically ill patients. Br J Haematol 2004, 125: 69-73. 10.1111/j.1365-2141.2004.04868.xCrossRefPubMed
46.
Dara SI, Rana R, Afessa B, Moore SB, Gajic O: Fresh frozen plasma transfusion in critically ill medical patients with coagulopathy. Crit Care Med 2005, 33: 2667-2671. 10.1097/01.CCM.0000186745.53059.F0CrossRefPubMed
47.
Etemadrezaie H, Baharvahdat H, Shariati Z, Lari SM, Shakeri MT, Ganjeifar B: The effect of fresh frozen plasma in severe closed head injury. Clin Neurol Neurosurg 2007, 109: 166-171. 10.1016/j.clineuro.2006.09.001CrossRefPubMed
48.
Khan H, Belsher J, Yilmaz M, Afessa B, Winters JL, Moore SB, Hubmayr RD, Gajic O: Fresh-frozen plasma and platelet transfusions are associated with development of acute lung injury in critically ill medical patients. Chest 2007, 131: 1308-1314. 10.1378/chest.06-3048CrossRefPubMed
49.
Snyder CW, Weinberg JA, McGwin G Jr, Melton SM, George RL, Reiff DA, Cross JM, Hubbard-Brown J, Rue LW, Kerby JD: The relationship of blood product ratio to mortality: survival benefit or survival bias? J Trauma 2009, 66: 358-362. 10.1097/TA.0b013e318196c3acCrossRefPubMed
50.
Geeraedts LM Jr, Demiral H, Schaap NP, Kamphuisen PW, Pompe JC, Frolke JP: 'Blind' transfusion of blood products in exsanguinating trauma patients. Resuscitation 2007, 73: 382-388. 10.1016/j.resuscitation.2006.10.005CrossRefPubMed
51.
Dzik WH: Predicting hemorrhage using preoperative coagulation screening assays. Curr Hematol Rep 2004, 3: 324-330.PubMed
52.
Kitchens CS: To bleed or not to bleed? Is that the question for the PTT? J Thromb Haemost 2005, 3: 2607-2611. 10.1111/j.1538-7836.2005.01552.xCrossRefPubMed
53.
Dempfle CE, Borggrefe M: Point of care coagulation tests in critically ill patients. Semin Thromb Hemost 2008, 34: 445-450. 10.1055/s-0028-1092874CrossRefPubMed
54.
Jackson GN, Ashpole KJ, Yentis SM: The TEG vs the ROTEM thromboelastography/thromboelastometry systems. Anaesthesia 2009, 64: 212-215. 10.1111/j.1365-2044.2008.05752.xCrossRefPubMed
55.
Kheirabadi BS, Crissey JM, Deguzman R, Holcomb JB: In vivo bleeding time and in vitro thrombelastography measurements are better indicators of dilutional hypothermic coagulopathy than prothrombin time. J Trauma 2007, 62: 1352-1359. 10.1097/TA.0b013e318047b805CrossRefPubMed
56.
Martini WZ, Cortez DS, Dubick MA, Park MS, Holcomb JB: Thrombelastography is better than PT, aPTT, and activated clotting time in detecting clinically relevant clotting abnormalities after hypothermia, hemorrhagic shock and resuscitation in pigs. J Trauma 2008, 65: 535-543. 10.1097/TA.0b013e31818379a6CrossRefPubMed
57.
Fenger-Eriksen C, Jensen TM, Kristensen BS, Jensen KM, Tonnesen E, Ingerslev J, Sorensen B: 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. 10.1111/j.1538-7836.2009.03331.xCrossRefPubMed
58.
Fries D, Innerhofer P, Schobersberger W: Time for changing coagulation management in trauma-related massive bleeding. Curr Opin Anaesthesiol 2009, 22: 267-274. 10.1097/ACO.0b013e32832678d9CrossRefPubMed
59.
Gerlach R, Krause M, Seifert V, Goerlinger K: Hemostatic and hemorrhagic problems in neurosurgical patients. Acta Neurochir (Wien) 2009, 151: 873-900. 10.1007/s00701-009-0409-zCrossRef
60.
Kashuk JL, Moore EE, Le T, Lawrence J, Pezold M, Johnson JL, Cothren CC, Biffl WL, Barnett C, Sabel A: Noncitrated whole blood is optimal for evaluation of postinjury coagulopathy with point-of-care rapid thrombelastography. J Surg Res 2009, 156: 133-138. 10.1016/j.jss.2009.03.046CrossRefPubMed
61.
Theusinger OM, Spahn DR, Ganter MT: Transfusion in trauma: why and how should we change our current practice? Curr Opin Anaesthesiol 2009, 22: 305-312. 10.1097/ACO.0b013e3283212c7cCrossRefPubMed
62.
Rahe-Meyer N, Solomon C, Winterhalter M, Piepenbrock S, Tanaka K, Haverich A, Pichlmaier M: 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. 10.1016/j.jtcvs.2008.11.065CrossRefPubMed
63.
Manco-Johnson MJ, Dimichele D, Castaman G, Fremann S, Knaub S, Kalina U, Peyvandi F, Piseddu G, Mannucci P: Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost 2009, 7: 2064-2069. 10.1111/j.1538-7836.2009.03633.xCrossRefPubMed
64.
Craig J, Aguiar-Ibanez R, Bhattacharya S, Downie S, Duff S, Kohli H, Nimmo A, Trueman P, Wilson S, Yunni Y: The clinical and cost effectiveness of thromboelastography/thromboelastometry. Health Technol Assess 2008, 11: 1-70.
65.
Moore L, Lavoie A, Turgeon AF, Abdous B, Le Sage N, Emond M, Liberman M, Bergeron E: The trauma risk adjustment model: a new model for evaluating trauma care. Ann Surg 2009, 249: 1040-1046. 10.1097/SLA.0b013e3181a6cd97CrossRefPubMed
66.
Hirschmann MT, Uike KN, Kaufmann M, Huegli R, Regazzoni P, Gross T: Quality management of interdisciplinary treatment of polytrauma. Possibilities and limits of retrospective routine data collection. Anaesthesist 2007, 56: 673-678. 10.1007/s00101-007-1192-yCrossRefPubMed
67.
Sanson G, Di Bartolomeo S, Nardi G, Albanese P, Diani A, Raffin L, Filippetto C, Cattarossi A, Scian E, Rizzi L: Road traffic accidents with vehicular entrapment: incidence of major injuries and need for advanced life support. Eur J Emerg Med 1999, 6: 285-291.CrossRefPubMed
Metadata
Title
Goal-directed coagulation management of major trauma patients using thromboelastometry (ROTEM®)-guided administration of fibrinogen concentrate and prothrombin complex concentrate
Authors
Herbert Schöchl
Ulrike Nienaber
Georg Hofer
Wolfgang Voelckel
Csilla Jambor
Gisela Scharbert
Sibylle Kozek-Langenecker
Cristina Solomon
Publication date
01-04-2010
Publisher
BioMed Central
Published in
Critical Care / Issue 2/2010
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/cc8948

Other articles of this Issue 2/2010

Critical Care 2/2010 Go to the issue

Research

Elderly patients undergoing mechanical ventilation in and out of intensive care units: a comparative, prospective study of 579 ventilations

Review

Bench-to-bedside review: Vaccine protection strategies during pandemic flu outbreaks

Research

Prospective monitoring of cefepime in intensive care unit adult patients

Letter

Freeze dried plasma: a French army specialty

Research

Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial

Review

Clinical review: Scoring systems in the critically ill