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E-FIT 1

Title
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
Study Type
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
Double blind randomised trial
Chief Investigator(s)
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
Dr Simon Stanworth and Nicola Curry
Primary Sponsor
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
NHSBT
Funder
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
CSL Behring
NHSBT Research Theme
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
Patient Blood Management
Summary
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage

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
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage

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: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
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.
Study Contact
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage

Claire Foley

Email: claire.foley@nhsbt.nhs.uk

Study Website
E-FIT1: Early-Fibrinogen in Trauma.
A multi-centre, randomised, double-blind, placebo-controlled trial evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage
E-FIT 1