E-FIT 1
Early-Fibrinogen in Trauma
The E-FIT 1 study is now complete.
Chief investigators: Dr Simon Stanworth and Nicola Curry
Primary sponsor: NHSBT
Funder: CSL Behring
Summary
As many as four in every ten patients affected by severe trauma die from uncontrolled bleeding. Many of these patients are found to have an abnormality of the clotting system, known as ‘acute traumatic coagulopathy’ (ATC).
The two most important abnormalities in ATC are a low fibrinogen and increased clot breakdown. It has been hypothesised, and there are some non-randomised studies that show, that treatment of trauma patients who are bleeding with fibrinogen therapy stops bleeding more effectively than standard care, reduces transfusion needs and may reduce death rates.
This study will look at the effects of infusing a drug (fibrinogen concentrate) which is a concentrated source of fibrinogen, to adult trauma patients within 45 minutes of admission to hospital. It has been shown from a large trauma RCT that early treatment for bleeding has better outcomes.
This study will evaluate whether it is possible to infuse drug within 45 minutes and will also look at laboratory and clinical outcome measures.
Study hypothesis
Major bleeding after injury is exacerbated by a clotting abnormality – ‘acute traumatic coagulopathy’ (ATC). ATC is characterised by hypofibrinogenaemia and fibrinolysis. Early replacement of fibrinogen will treat the coagulopathy and may reduce bleeding and improve outcomes.
This study will evaluate the clinical and laboratory effects of early fibrinogen supplementation during major traumatic haemorrhage.
Study design
E-FIT1 is a multi-centre, interventional, randomised, double-blind, parallel, placebo-controlled feasibility trial. Patients will be randomised 1:1 via pre-labelled study drug packs in ED. The study will be run and conducted in UK.
Publications
Nicola Curry, Claire Foley, Henna Wong, Ana Mora, Elinor Curnow, Agne Zarankaite, Renate Hodge, Valerie Hopkins, Alison Deary, James Ray, Phil Moss, Matthew J reed, Suzanne Kellett, Ross Davenport and Simon Stanworth. Early Fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multicentre, randomised, double blind, placebo controlled trial. Critical Care 2018 22:164 DOI.org/10.1186/s13054-018-2086-x'
N. Curry, C. Foley, H. Wong, E. Curnow, A. Zarankaite, R. Hodge, V. Hopkins, A. Deary, J.Ray, P. Moss, M. J. Reed, S. Kellett, R. Davenport, S. Stanworth. The application of a haemorrhage assessment tool in evaluating control of bleeding in a pilot trauma haemorrhage trial. doi: 10.1111/tme.12644