E-FIT 1 v1.0
Research type
Research Study
Full title
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 Study
IRAS ID
164933
Contact name
Simon Stanworth
Contact email
Eudract number
2015-000875-28
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
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.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0316
Date of REC Opinion
15 Jul 2015
REC opinion
Further Information Favourable Opinion