Administration of fibrinogen concentrate for refractory bleeding in massively transfused, non-trauma patients with coagulopathy: a retrospective study with comparator group

BMC Anesthesiology

Santiago R Leal-Noval¹  Manuel Casado¹  Victoria Arellano-Orden¹  Reginald Dusseck¹  Javier Bautista-Paloma²  Manuel Muñoz⁴  José Naranjo-Izorieta¹  Antonio Puppo Moreno¹  Aurelio Cayuela³ 

[1] Critical Care Division, Hospital Universitario “Virgen del Rocío” and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain

[2] Pharmacy Division, Hospital Universitario “Virgen del Rocío” and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain

[3] Statistics and Design Division, Hospital del Valme, Seville, Spain

[4] Transfusion Medicine, University of Málaga, Málaga, Spain

关键词: Transfusion;    FIBTEM;    TEG;    Thromboelastography;    ROTEM;    Thromboelastometry;    Massive transfusion protocol;    Goal directed therapy;    Fibrinogen concentrate;    Clauss method;    Bleeding;    Anaemia;   

Others  :  1084241
DOI  :  10.1186/1471-2253-14-109

 received in 2014-08-25, accepted in 2014-11-12,  发布年份 2014

【 摘 要 】

Background

This retrospective, single centre study was conducted to investigate the efficacy of fibrinogen concentrate (FBNc) in decreasing blood requirements and reaching optimal fibrinogen level, in non-trauma, massively transfused, bleeding patients with coagulopathy.

Methods

Over a 3-years period, all patients for whom a massive transfusion protocol was activated and had received ≥4 units of allogeneic blood components within a ≤4 h period, were included. Patients were classified according to whether they received FBNc or achieved an optimal fibrinogen level of ≥2 g/L within 24 h after FBNc administration.

Results

Seventy-one patients received 2 [2,4] g of FBNc (FBNc group) and 72 did not (comparator group). FBNc was administered after transfusing 5 [5,9] blood component units, 3 [2,6] hours after massive transfusion protocol activation. Linear regression analysis showed that SOFA (AOR 0.75 [95% CI:0.08-1.43]) and admission fibrinogen level (AOR -2.7 [95% CI:-4.68 – -0.78]), but not FBNc administration, were independently associated with total transfused units. There was a significant inverse relation between both admission and target fibrinogen levels, and total transfused components. Logistic regression showed a direct relationship between admission fibrinogen level and achieving a target level ≥2 g/L (AOR 3.29 [95% CI;1.95-5.56]). No thromboembolic events associated with FBNc were observed.

Conclusions

In massively transfused, non-trauma patients with coagulopathy and refractory bleeding, late administration of low FBNc dosage was not associated with decreased blood transfusion or increased post-infusion fibrinogen level. Given that both fibrinogen upon admission and target fibrinogen levels were associated with decreased blood transfusion, earlier administration and higher doses of FBNc could be needed.

【 授权许可】

   
2014 Leal-Noval et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Levy JH, Szlam F, Tanaka K, Sniecienski RM: Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesth Analg 2012, 114:261-274.
• [2]Hunt BJ: Bleeding and coagulopathy in critical care. New Engl J Med 2014, 370:847-859.
• [3]Kozek-Langenecker S, Sørensen B, Hess JR, Spahn DR: Clinical effectiveness of fresh frozen plasma compared with fibrinogen concentrate: a systematic review. Crit Care 2011, 15:R239. BioMed Central Full Text
• [4]Rahe-Meyer N, Sørensen B: Fibrinogen concentrate for management of bleeding. J Thromb Haemost 2011, 9:1-5.
• [5]Schöchl H, Schlimp CJ: Trauma bleeding management: the concept of goal-directed primary care. Anesth Analg 2013. Epub ahead of print
• [6]Wikkelsø A, Lunde J, Johansen M, Stensballe J, Wetterslev J, Møller AM, Afshari A: Fibrinogen concentrate in bleeding patients (Review). 8th edition. 2013. [The Cochrane Library]
• [7]Pham HP, Shaz BH: Update of massive transfusion. Br J Anaesthe 2013, 111(S1):i71-i82.
• [8]Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sørensen B, Hagl C, Pichlmaier M: Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery. Anesthesiology 2013, 118:40-50.
• [9]Görlinger K, Dirkmann D, Hanke AA, Kamler M, Kottenberg E, Thielmann M, Jakob H, Peters J: First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery. Anesthesiology 2011, 115:1179-1191.
• [10]Kozek-Langenecker S, Afshari A, Albaladejo P, Aldecoa Alvarez Santullano C, De Robertis E, Filipescu DC, Fries D, Görlinger K, Haas T, Imberger G, Jacob M, Lancé M, Llau J, Mallett S, Meier J, Rahe-Meyer N, Samama CM, Smith A, Solomon C, Van der Linden P, Wikkelsø AJ, Wouters P, Wyffels P: Management of severe perioperative bleeding guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol 2013, 30:270-382.
• [11]Dzik WH, Blajchman MA, Fergusson D, Hameed M, Blair H, Kirkpatrick AW, Korogyi T, Logsetty S, Skeate RC, Stanworth S, MacAdams C, Muirhead B: Clinical review: Canadian National Advisory Committee on blood and blood products –massive transfusion consensus conference 2011: report of the panel. Crit Care 2011, 15:242. BioMed Central Full Text
• [12]Leal-Noval SR, Muñoz M, Asuero M, Contreras E, García-Erce JA, Llau JV, Moral V, Páramo JA, Quintana M, Spanish Expert Panel on Alternatives to Allogeneic Blood Transfusion: Spanish Consensus Statement on alternatives to allogeneic blood transfusion: the 2013 update of the “Seville Document”. Blood Transfus 2013, 11:585-610.
• [13]Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Férnandez-Mondéjar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R: Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care 2013, 17:R76. BioMed Central Full Text
• [14]Kozek-Langenecker S, Fries D, Spahn DR, Zacharowski K: Fibrinogen concentrate: clinical reality and cautious cochrane recommendation. Br J Anaesth 2014. doi:10.1093/bja/aeu004
• [15]Bollinger D, Tanaka KA: Roles of thrombelastography and thromboelastometry for patient blood management in cardiac surgery. Transfus Med Rev 2013, 27:213-220.
• [16]Morse B, Dente C, Hodgman EI, Shaz B, Winkler A, Nicholas JM, Wyrzykowski AD, Rozycki GS, Feliciano DV: Outcomes after massive transfusion in nontrauma patients in the era of damage control resuscitation. Am Surg 2012, 78:679-684.
• [17]McDaniel LM, Neal MD, Sperry JL, Alarcon LH, Forsythe RM, Triulzi D, Peitzman AB, Raval JS: Use of a massive transfusion protocol in nontrauma patients: activate away. J Am Coll Surg 2013, 216:1103-1109.
• [18]Thomas D, Wee M, Clyburn P, Walker I, Brohi K, Collins P, Doughty H, Isaac J, Mahoney PM, Shewry L: Guidelines. blood transfusion and the anaesthetist: management of massive haemorrhage. Anaesthesia 2010, 65:1153-1161.
• [19]National Blood Authority: Patient blood management guidelines: module 1. [Critical bleeding/massive transfusion] http://www.blood.gov.au/pbmmodule-1 webcite (accessed Jul 2013)
• [20]Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, Saha SP, Song HK, Clough ER, Shore-Lesserson LJ, Goodnough LT, Mazer CD, Shander A, Stafford-Smith M, Waters J, Baker RA, Dickinson TA, FitzGerald DJ, Likosky DS, Shann KG, Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion: Update to the society of thoracic surgeons and the society of cardiovascular anesthesiologists blood conservation clinical practice guidelines. society of thoracic surgeons blood conservation guideline task force; society of cardiovascular anesthesiologists special task force on blood transfusion. International consortium for evidence based perfusion. Ann Thorac Surg 2011, 91:944-982.
• [21]Gielen C, Dekkers O, Stijnen T, Schoones J, Brand A, Klautz R, Eikenboom J: 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.
• [22]Stainsby D, MacLennan S, Thomas D, Isaac J, Hamilton PJ, British Committee for Standards in Haematology: Writing Group: Guidelines on the management of massive blood loss. Br J Haemathol 2006, 135:634-641.
• [23]Farriols A, Cuenca L, Rodríguez S, Mendarte L, Montoro B: Efficacy and tolerability of human fibrinogen concentrate administration to patients with adquired fibrinogen deficiency and active or in high-risk severe bleeding. Vox Sang 2008, 94(3):221-226.
• [24]Schöchl H, Nienaber U, Hofer G, Voelckel W, Jambor C, Scharbert G, Kozek-Langenecker S, Solomon C: RGesoeaarclh-directed coagulation management of major trauma patients using thromboelastometry (ROTEM®)-guided administration of fibrinogen concentrate and prothrombin complex concentrate. Crit Care 2010, 14:R55. BioMed Central Full Text
• [25]Tanaka A, Esper S, Bolliger D: Perioperative factor concentrate therapy. Brit J Anaesthes 2013, 111(S1):i35-i49.