We are excited to announce that the E-FIT1 study has now commenced within the department. This is a study led by the NHS Blood Transfusion team (NHSBT). Dr Matt Reed is the Principal Investigator for the Edinburgh site. We are the first site up and running and are very eager to recruit our first participant.
The research nurses page has been attached to the code red alert so we will be actively recruiting patients with severe traumatic bleeding in the ED.
The main objective of the E-FIT 1 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.
We are aiming to recruit 48 patients over 18 months in the United Kingdom.
Patients are eligible for this trial if:
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 on-going 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
If you are one of the self nominated doctors who will be delegated for the study and haven’t been trained, please contact Bernadette Gallagher, Senior Research Nurse. E-FIT1 training should take approximately 30 mins.
If a patient with a traumatic haemorrhage has arrived in the ED please look out for the research team or alert them on Page 4116 if they have not arrived.
