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E-FIT1 Trial

Start date:
December 2015
End date:
April 2017
Co-ordinated by:
Dr Simon Stanworth, University of Oxford
Main trial site:
RIE

Injury is a leading cause of death and disability worldwide. Around 7,800 people die in England every year, and many thousands more are left severely disabled. Uncontrolled bleeding is the main cause of death in 40% of cases. Transfusion therapy(which includes giving patients additional red blood cells, fresh frozen plasma, platelets and cryoprecipitate) is an important part of emergency treatment for major bleeding. Although the standard transfusion therapy is routinely followed in all hospitals, we are not sure whether by giving an additional source of fibrinogen, with a drug called fibrinogen concentrate, as quickly as possible is more effective than standard practice. The main objective of this clinical trial is to test whether it is possible to give fibrinogen concentrate within 45 minutes of admission to hospital to adult trauma patients with severe bleeding. One group of patients who take part in the study will receive early administration of fibrinogen concentrate in addition to standard major haemorrhage therapy, whilst the other group will be given a placebo or “dummy” drug in additional to the standard major haemorrhage therapy. The effects of the two treatment regimes will be compared, in particular focussing on differences in blood test results and clinical outcomes such as bleeding and organ failure.

 

Main Inclusion Criteria
1. Written informed consent or agreement, or waiver of consent, is obtained before any study related activity
2. The participant is judged to be an adult (aged 16 years or over) and is affected by traumatic injury
3. The participant is deemed by the attending clinician to have ongoing active haemorrhage with shock
AND REQUIRES:
4. activation of the local major haemorrhage protocol for management of severe blood loss and/or transfusion of emergency (Group O) red cells
Main Exclusion Criteria
1. The participant has been transferred from another hospital
2. The trauma team leader deems the patient inappropriate for the trial i.e. injuries deemed to be incompatible with life
3. More than 3 hours have elapsed from the time of injury
4. The participant is pregnant
5. Severe isolated TBI or unsalvageable head injury

Local PI

Dr Matt Reed

Director of EMERGE, Consultant, NRS Career Research Fellow & Honorary Reader in Emergency Medicine

Research Team

Bernadette Gallagher

Senior Research Nurse

Emma Ward

Research Administrator

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