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Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study

BACKGROUND: Trauma-induced coagulopathy (TIC) substantially contributes to mortality in bleeding trauma patients. OBJECTIVE: The aim of the study was to administer fibrinogen concentrate in the prehospital setting to improve blood clot stability in trauma patients bleeding or presumed to bleed. DESI...

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Autores principales: Ziegler, Bernhard, Bachler, Mirjam, Haberfellner, Hubert, Niederwanger, Christian, Innerhofer, Petra, Hell, Tobias, Kaufmann, Marc, Maegele, Marc, Martinowitz, Uriel, Nebl, Carolin, Oswald, Elgar, Schöchl, Herbert, Schenk, Bettina, Thaler, Markus, Treichl, Benjamin, Voelckel, Wolfgang, Zykova, Ivana, Wimmer, Christine, Fries, Dietmar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969176/
https://www.ncbi.nlm.nih.gov/pubmed/33109923
http://dx.doi.org/10.1097/EJA.0000000000001366
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author Ziegler, Bernhard
Bachler, Mirjam
Haberfellner, Hubert
Niederwanger, Christian
Innerhofer, Petra
Hell, Tobias
Kaufmann, Marc
Maegele, Marc
Martinowitz, Uriel
Nebl, Carolin
Oswald, Elgar
Schöchl, Herbert
Schenk, Bettina
Thaler, Markus
Treichl, Benjamin
Voelckel, Wolfgang
Zykova, Ivana
Wimmer, Christine
Fries, Dietmar
author_facet Ziegler, Bernhard
Bachler, Mirjam
Haberfellner, Hubert
Niederwanger, Christian
Innerhofer, Petra
Hell, Tobias
Kaufmann, Marc
Maegele, Marc
Martinowitz, Uriel
Nebl, Carolin
Oswald, Elgar
Schöchl, Herbert
Schenk, Bettina
Thaler, Markus
Treichl, Benjamin
Voelckel, Wolfgang
Zykova, Ivana
Wimmer, Christine
Fries, Dietmar
author_sort Ziegler, Bernhard
collection PubMed
description BACKGROUND: Trauma-induced coagulopathy (TIC) substantially contributes to mortality in bleeding trauma patients. OBJECTIVE: The aim of the study was to administer fibrinogen concentrate in the prehospital setting to improve blood clot stability in trauma patients bleeding or presumed to bleed. DESIGN: A prospective, randomised, placebo-controlled, double-blinded, international clinical trial. SETTING: This emergency care trial was conducted in 12 Helicopter Emergency Medical Services (HEMS) and Emergency Doctors’ vehicles (NEF or NAW) and four trauma centres in Austria, Germany and Czech Republic between 2011 and 2015. PATIENTS: A total of 53 evaluable trauma patients aged at least 18 years with major bleeding and in need of volume therapy were included, of whom 28 received fibrinogen concentrate and 25 received placebo. INTERVENTIONS: Patients were allocated to receive either fibrinogen concentrate or placebo prehospital at the scene or during transportation to the study centre. MAIN OUTCOME MEASURES: Primary outcome was the assessment of clot stability as reflected by maximum clot firmness in the FIBTEM assay (FIBTEM MCF) before and after administration of the study drug. RESULTS: Median FIBTEM MCF decreased in the placebo group between baseline (before administration of study treatment) and admission to the Emergency Department, from a median of 12.5 [IQR 10.5 to 14] mm to 11 [9.5 to 13] mm (P = 0.0226), but increased in the FC Group from 13 [11 to 15] mm to 15 [13.5 to 17] mm (P = 0.0062). The median between-group difference in the change in FIBTEM MCF was 5 [3 to 7] mm (P < 0.0001). Median fibrinogen plasma concentrations in the fibrinogen concentrate Group were kept above the recommended critical threshold of 2.0 g l(−1) throughout the observation period. CONCLUSION: Early fibrinogen concentrate administration is feasible in the complex and time-sensitive environment of prehospital trauma care. It protects against early fibrinogen depletion, and promotes rapid blood clot initiation and clot stability. TRIAL REGISTRY NUMBERS: EudraCT: 2010-022923-31 and ClinicalTrials.gov: NCT01475344.
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spelling pubmed-79691762021-03-29 Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study Ziegler, Bernhard Bachler, Mirjam Haberfellner, Hubert Niederwanger, Christian Innerhofer, Petra Hell, Tobias Kaufmann, Marc Maegele, Marc Martinowitz, Uriel Nebl, Carolin Oswald, Elgar Schöchl, Herbert Schenk, Bettina Thaler, Markus Treichl, Benjamin Voelckel, Wolfgang Zykova, Ivana Wimmer, Christine Fries, Dietmar Eur J Anaesthesiol Haemostasis-Transfusion BACKGROUND: Trauma-induced coagulopathy (TIC) substantially contributes to mortality in bleeding trauma patients. OBJECTIVE: The aim of the study was to administer fibrinogen concentrate in the prehospital setting to improve blood clot stability in trauma patients bleeding or presumed to bleed. DESIGN: A prospective, randomised, placebo-controlled, double-blinded, international clinical trial. SETTING: This emergency care trial was conducted in 12 Helicopter Emergency Medical Services (HEMS) and Emergency Doctors’ vehicles (NEF or NAW) and four trauma centres in Austria, Germany and Czech Republic between 2011 and 2015. PATIENTS: A total of 53 evaluable trauma patients aged at least 18 years with major bleeding and in need of volume therapy were included, of whom 28 received fibrinogen concentrate and 25 received placebo. INTERVENTIONS: Patients were allocated to receive either fibrinogen concentrate or placebo prehospital at the scene or during transportation to the study centre. MAIN OUTCOME MEASURES: Primary outcome was the assessment of clot stability as reflected by maximum clot firmness in the FIBTEM assay (FIBTEM MCF) before and after administration of the study drug. RESULTS: Median FIBTEM MCF decreased in the placebo group between baseline (before administration of study treatment) and admission to the Emergency Department, from a median of 12.5 [IQR 10.5 to 14] mm to 11 [9.5 to 13] mm (P = 0.0226), but increased in the FC Group from 13 [11 to 15] mm to 15 [13.5 to 17] mm (P = 0.0062). The median between-group difference in the change in FIBTEM MCF was 5 [3 to 7] mm (P < 0.0001). Median fibrinogen plasma concentrations in the fibrinogen concentrate Group were kept above the recommended critical threshold of 2.0 g l(−1) throughout the observation period. CONCLUSION: Early fibrinogen concentrate administration is feasible in the complex and time-sensitive environment of prehospital trauma care. It protects against early fibrinogen depletion, and promotes rapid blood clot initiation and clot stability. TRIAL REGISTRY NUMBERS: EudraCT: 2010-022923-31 and ClinicalTrials.gov: NCT01475344. Lippincott Williams & Wilkins 2021-04 2020-10-28 /pmc/articles/PMC7969176/ /pubmed/33109923 http://dx.doi.org/10.1097/EJA.0000000000001366 Text en Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Society of Anaesthesiology. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0
spellingShingle Haemostasis-Transfusion
Ziegler, Bernhard
Bachler, Mirjam
Haberfellner, Hubert
Niederwanger, Christian
Innerhofer, Petra
Hell, Tobias
Kaufmann, Marc
Maegele, Marc
Martinowitz, Uriel
Nebl, Carolin
Oswald, Elgar
Schöchl, Herbert
Schenk, Bettina
Thaler, Markus
Treichl, Benjamin
Voelckel, Wolfgang
Zykova, Ivana
Wimmer, Christine
Fries, Dietmar
Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study
title Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study
title_full Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study
title_fullStr Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study
title_full_unstemmed Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study
title_short Efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (FIinTIC): A multicentre, double-blind, placebo-controlled, randomised pilot study
title_sort efficacy of prehospital administration of fibrinogen concentrate in trauma patients bleeding or presumed to bleed (fiintic): a multicentre, double-blind, placebo-controlled, randomised pilot study
topic Haemostasis-Transfusion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969176/
https://www.ncbi.nlm.nih.gov/pubmed/33109923
http://dx.doi.org/10.1097/EJA.0000000000001366
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