Pre-hospital Administration of Fibrinogen in Trauma-Induced Coagulopathy

Summary

A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding. The main endpoints are: 1. Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death. 2. Administration feasibility of FC within the prehospital setting. Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.

Timeline

Start

2025-01-01

Primary completion

2025-08-31

Completion

2025-12-31

Publications

• Background Winearls J, Wullschleger M, Wake E, Hurn C, Furyk J, Ryan G, Trout M, Walsham J, Holley A, Cohen J, Shuttleworth M, Dyer W, Keijzers G, Fraser JF, Presneill J, Campbell D. Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial. Trials. 2017 May 26;18(1):241. doi: 10.1186/s13063-017-1980-x.
• Background Lucena LS, Rodrigues RDR, Carmona MJC, Noronha FJD, Oliveira HP, Lima NM, Pinheiro RB, Silva WAD, Cavalcanti AB. Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial. Clinics (Sao Paulo). 2021 Nov 8;76:e3168. doi: 10.6061/clinics/2021/e3168. eCollection 2021.
• Background Ziegler B, Bachler M, Haberfellner H, Niederwanger C, Innerhofer P, Hell T, Kaufmann M, Maegele M, Martinowitz U, Nebl C, Oswald E, Schochl H, Schenk B, Thaler M, Treichl B, Voelckel W, Zykova I, Wimmer C, Fries D; FIinTIC study group. 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. Eur J Anaesthesiol. 2021 Apr 1;38(4):348-357. doi: 10.1097/EJA.0000000000001366.
• Background Aubron C, Reade MC, Fraser JF, Cooper DJ. Efficacy and safety of fibrinogen concentrate in trauma patients--a systematic review. J Crit Care. 2014 Jun;29(3):471.e11-7. doi: 10.1016/j.jcrc.2013.12.011. Epub 2013 Dec 30.
• Background Bodnar D, Bosley E, Raven S, Williams S, Ryan G, Wullschleger M, Lam AK. The nature and timing of coagulation dysfunction in a cohort of trauma patients in the Australian pre-hospital setting. Injury. 2024 Jan;55(1):111124. doi: 10.1016/j.injury.2023.111124. Epub 2023 Oct 14.
• Background Innerhofer N, Treichl B, Rugg C, Fries D, Mittermayr M, Hell T, Oswald E, Innerhofer P, On Behalf Of The Retic Study Group. First-Line Administration of Fibrinogen Concentrate in the Bleeding Trauma Patient: Searching for Effective Dosages and Optimal Post-Treatment Levels Limiting Massive Transfusion-Further Results of the RETIC Study. J Clin Med. 2021 Aug 31;10(17):3930. doi: 10.3390/jcm10173930.
• Background Schochl H, Nienaber U, Hofer G, Voelckel W, Jambor C, Scharbert G, Kozek-Langenecker S, Solomon C. Goal-directed coagulation management of major trauma patients using thromboelastometry (ROTEM)-guided administration of fibrinogen concentrate and prothrombin complex concentrate. Crit Care. 2010;14(2):R55. doi: 10.1186/cc8948. Epub 2010 Apr 7.
• Background Wafaisade A, Lefering R, Maegele M, Brockamp T, Mutschler M, Lendemans S, Banerjee M, Bouillon B, Probst C; Trauma Registry of DGU. Administration of fibrinogen concentrate in exsanguinating trauma patients is associated with improved survival at 6 hours but not at discharge. J Trauma Acute Care Surg. 2013 Feb;74(2):387-3; discussion 393-5. doi: 10.1097/TA.0b013e31827e2410.
• Background Seebold JA, Campbell D, Wake E, Walters K, Ho D, Chan E, Bulmer AC, Wullschleger M, Winearls J. Targeted fibrinogen concentrate use in severe traumatic haemorrhage. Crit Care Resusc. 2019 Sep;21(3):171-178.
• Background Nascimento B, Callum J, Tien H, Peng H, Rizoli S, Karanicolas P, Alam A, Xiong W, Selby R, Garzon AM, Colavecchia C, Howald R, Nathens A, Beckett A. Fibrinogen in the initial resuscitation of severe trauma (FiiRST): a randomized feasibility trial. Br J Anaesth. 2016 Dec;117(6):775-782. doi: 10.1093/bja/aew343.
• Background Kelly JM, Rizoli S, Veigas P, Hollands S, Min A. Using rotational thromboelastometry clot firmness at 5 minutes (ROTEM(R) EXTEM A5) to predict massive transfusion and in-hospital mortality in trauma: a retrospective analysis of 1146 patients. Anaesthesia. 2018 Sep;73(9):1103-1109. doi: 10.1111/anae.14297. Epub 2018 Apr 16.
• Background Blayney A, McCullough J, Wake E, Walters K, Campbell D, Ho D, Chan E, Chalasani A, Winearls J. Substitution of ROTEM FIBTEM A5 for A10 in trauma: an observational study building a case for more rapid analysis of coagulopathy. Eur J Trauma Emerg Surg. 2022 Apr;48(2):1077-1084. doi: 10.1007/s00068-021-01652-w. Epub 2021 Jun 16.
• Background Yurashevich M, Rosser M, Small M, Grotegut C, Kota N, Toffaletti J, Allen T. Evaluating the Association Between Fibrinogen and Rotational Thromboelastometry and the Progression to Severe Obstetric Hemorrhage. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231175089. doi: 10.1177/10760296231175089.
• Background Hayakawa M. Dynamics of fibrinogen in acute phases of trauma. J Intensive Care. 2017 Jan 20;5(1):3. doi: 10.1186/s40560-016-0199-3.
• Background Okada A, Okada Y, Inoue M, Narumiya H, Nakamoto O. Lactate and fibrinogen as good predictors of massive transfusion in postpartum hemorrhage. Acute Med Surg. 2019 Oct 14;7(1):e453. doi: 10.1002/ams2.453. eCollection 2020 Jan-Dec.
• Background Cho ES, McClelland PH, Cheng O, Kim Y, Hu J, Zenilman ME, D'Ayala M. Utility of d-dimer for diagnosis of deep vein thrombosis in coronavirus disease-19 infection. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):47-53. doi: 10.1016/j.jvsv.2020.07.009. Epub 2020 Jul 30.
• Background Soye JA, Loughrey CB, Hanley PD. Computed tomography pulmonary angiography: a sample of experience at a District General Hospital. Ulster Med J. 2008 Sep;77(3):175-80.
• Background Prisco D, Grifoni E. The role of D-dimer testing in patients with suspected venous thromboembolism. Semin Thromb Hemost. 2009 Feb;35(1):50-9. doi: 10.1055/s-0029-1214148. Epub 2009 Mar 23.
• Background Hasan TF, Hasan H, Kelley RE. Overview of Acute Ischemic Stroke Evaluation and Management. Biomedicines. 2021 Oct 16;9(10):1486. doi: 10.3390/biomedicines9101486.

Drugs

Indications

No indication recorded.