A randomised controlled trial of fibrinogen concentrate during scoliosis surgery

W Chen, J Shen, Y Zhang, A Hu, J Liang, L Ma, X Yu, Y Huang, W Chen, J Shen, Y Zhang, A Hu, J Liang, L Ma, X Yu, Y Huang

Abstract

Bleeding and blood transfusion are common after scoliosis surgery. Fibrinogen is essential for blood clot formation and depletes quickly during haemorrhage. We randomly allocated 102 children 12-18 years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30 mg.kg-1 (maximum 2 g) and 51 to saline placebo. Fibrinogen reduced peri-operative blood loss by a median (95%CI) volume of 155 (5-320) ml, from a median (IQR [range]) of 1035 (818-1420 [400-3030]) ml to 885 (755-1155 [270-2645]) ml, p = 0.04. Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34. There were no side-effects.

Trial registration: ClinicalTrials.gov NCT03183479.

Keywords: blood loss; fibrinogen; orthopaedic; scoliosis; surgery; transfusion.

© 2020 Association of Anaesthetists.

References

    1. Altaf F, Gibson A, Dannawi Z, Noordeen H. Adolescent idiopathic scoliosis. British Medical Journal 2013; 346: f2508.
    1. Carling MS, Jeppsson A, Wessberg P, Henriksson A, Baghaei F, Brisby H. Preoperative fibrinogen plasma concentration is associated with perioperative bleeding and transfusion requirements in scoliosis surgery. Spine 2011; 36: 549-55.
    1. Wang M, Zheng XF, Jiang LS. Efficacy and safety of antifibrinolytic agents in reducing perioperative blood loss and transfusion requirements in scoliosis surgery: a systematic review and meta-analysis. PLoS One 2015; 10: e0137886.
    1. Lavoie J. Blood transfusion risks and alternative strategies in pediatric patients. Pediatric Anesthesia 2011; 21: 14-24.
    1. Bateman ST, Lacroix J, Boven K, et al. Anemia, blood loss, and blood transfusions in North American children in the intensive care unit. American Journal of Respiratory and Critical Care Medicine 2008; 178: 26-33.
    1. Sorensen B, Larsen OH, Rea CJ, Tang M, Foley JH, Fenger-Eriksen C. Fibrinogen as a hemostatic agent. Seminars in Thrombosis and Hemostasis 2012; 38: 268-73.
    1. Erdoes G, Koster A, Meesters MI, et al. The role of fibrinogen and fibrinogen concentrate in cardiac surgery: an international consensus statement from the Haemostasis and Transfusion Scientific Subcommittee of the European Association of Cardiothoracic Anaesthesiology. Anaesthesia 2019; 74: 1589-600.
    1. Haas T, Spielmann N, Restin T, et al. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: a prospective randomised controlled trial. British Journal of Anaesthesia 2015; 115: 234-43.
    1. Kozek-Langenecker SA, Ahmed AB, Afshari A, et al. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: first update 2016. European Journal of Anaesthesiology 2017; 34: 332-95.
    1. Geck MJ, Singh D, Gunn H, Stokes J, Truumees E. Is preoperative fibrinogen testing associated with total blood loss in adolescent idiopathic scoliosis correction. Spine Deformity 2017; 5: 381-6.
    1. Carson JL, Guyatt G, Heddle NM, et al. Clinical practice guidelines From the AABB: red blood cell transfusion thresholds and storage. Journal of the American Medical Association 2016; 316: 2025-35.
    1. Kaufman RM, Djulbegovic B, Gernsheimer T, et al. Platelet transfusion: a clinical practice guideline from the AABB. Annals of Internal Medicine 2015; 162: 205-13.
    1. Roback JD, Caldwell S, Carson J, et al. Evidence-based practice guidelines for plasma transfusion. Transfusion 2010; 50: 1227-39.
    1. Shapiro F, Sethna N. Blood loss in pediatric spine surgery. European Spine Journal 2004; 13(Suppl 1): S6-17.
    1. Yang D, Dalton JE. A unified approach to measuring the effect size between two groups using SAS®. SAS Global Forum 2012; 2012: 335-2012.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences, 2nd edn. Hillsdale, NJ: Lawrence Erlbaum Associates Publishers, 1988.
    1. Jeppsson A, Walden K, Roman-Emanuel C, Thimour-Bergstrom L, Karlsson M. Preoperative supplementation with fibrinogen concentrate in cardiac surgery: a randomized controlled study. British Journal of Anaesthesia 2016; 116: 208-14.
    1. Rahe-Meyer N, Levy JH, Mazer CD, et al. Randomized evaluation of fibrinogen vs placebo in complex cardiovascular surgery (REPLACE): a double-blind phase III study of haemostatic therapy. British Journal of Anaesthesia 2016; 117: 41-51.
    1. Ranucci M, Baryshnikova E, Crapelli GB, et al. Randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery. Journal of the American Heart Association 2015; 4: e002066.
    1. Karlsson M, Ternstrom L, Hyllner M, et al. Prophylactic fibrinogen infusion reduces bleeding after coronary artery bypass surgery. A prospective randomised pilot study. Thrombosis and Haemostasis 2009; 102: 137-44.
    1. Rahe-Meyer N, Solomon C, Hanke A, et al. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized placebo-controlled trial. Anesthesiology 2013; 118: 40-50.
    1. Soleimani M, Masoumi N, Nooraei N, Lashay A, Safarinejad MR. The effect of fibrinogen concentrate on perioperative bleeding in transurethral resection of the prostate: a double-blind placebo-controlled and randomized study. Journal of Thrombosis and Haemostasis 2017; 15: 255-62.
    1. Roy A, Stanford S, Nunn S, et al. Efficacy of fibrinogen concentrate in major abdominal surgery - a prospective, randomized, controlled study in cytoreductive surgery for pseudomyxoma peritonei. Journal of Thrombosis and Haemostasis 2020; 18: 352-63.
    1. Wikkelso AJ, Edwards HM, Afshari A, et al. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial. British Journal of Anaesthesia 2015; 114: 623-33.
    1. 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. British Journal of Anaesthesia 2017; 119: 411-21.
    1. Yu X, Xiao H, Wang R, Huang Y. Prediction of massive blood loss in scoliosis surgery from preoperative variables. Spine 2013; 38: 350-5.
    1. Lenoir B, Merckx P, Paugamburtz C, et al. Individual probability of allogeneic erythrocyte transfusion in elective spine surgery: the predictive model of transfusion in spine surgery. Anesthesiology 2009; 110: 1050-60.
    1. Hassan N, Halanski M, Wincek J, et al. Blood management in pediatric spinal deformity surgery: review of a 2-year experience. Transfusion 2011; 51: 2133-41.
    1. Costa-Filho R, Hochleitner G, Wendt M, Teruya A, Spahn DR. Over 50 years of fibrinogen concentrate. Clinical and Applied Thrombosis/Hemostasis 2016; 22: 109-14.
    1. Walden K, Shams Hakimi C, Jeppsson A, Karlsson M. Effects of fibrinogen supplementation on clot formation in blood samples from cardiac surgery patients before and after tranexamic acid administration. Transfusion Medicine 2019; 29: 319-24.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner