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

From the Department of Anaesthesiology, Perioperative Medicine and General Intensive Care Medicine, Paracelsus Medical University, Salzburg (BZ), Department of General and Surgical Critical Care Medicine, (MB, BS, DF ), Department of Anaesthesiology and Intensive Care Medicine (HH, PI, MK, EO, MT, BT), Department of Pediatrics, Pediatrics I, Intensive Care Unit, Medical University of Innsbruck, Innsbruck (CN), Department of Mathematics, Faculty of Mathematics, Computer Science and Physics, University of Innsbruck, Technikerstrasse, Austria (TH), Department of Trauma and Orthopedic Surgery, Cologne-Merheim Medical Center (CMMC), University Witten/Herdecke (UW/H), Campus Cologne-Merheim, Cologne, Germany (MM), Institute of Thrombosis and Haemostasis and the National Haemophilia Centre, The Chaim Sheba Medical Centre, Tel Hashomer, Israel (UM), Sportclinic Zillertal GmbH, Mayrhofen, Austria (CN), Department of Anaesthesiology and Intensive Care Medicine, AUVA Trauma Centre Salzburg, Academic Teaching Hospital of the Paracelsus Medical University, Salzburg, Austria (HS, WV), Department of Anesthesiology and Intensive Care, Liberec Regional Hospital, Liberec, Czech Republic (IZ), Christophorus 14, Niederöblarn, Austria (CW).

European journal of anaesthesiology. 2020
PICO Summary

Population

Trauma patients with major bleeding and in need of volume therapy (n= 53).

Intervention

Fibrinogen concentrate (FC), prehospital at the scene or during transportation to the study centre (n=28).

Comparison

Placebo (n= 25).

Outcome

Median maximum clot firmness in the FIBTEM assay decreased in patients receiving placebo between baseline (before administration of study treatment) and admission to the Emergency Department, from a median of 12.5mm to 11mm, but increased in patients receiving FC from 13mm to 15mm. The median between-group difference in the change in FIBTEM MCF was 5mm.
Abstract
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 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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine