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
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
Director of EMERGE, Consultant, NRS Career Research Fellow & Honorary Reader in Emergency Medicine
30 Dec 2015 | Bernadette Gallagher
Severe Traumatic Haemorrhage - Page Research Nurses on 4116Read more
People who develop an Acute Kidney Injury (AKI) often have a poor prognosis and many go on to develop chronic kidney disease (CKD). The recognition that AKI and CKD are linked is recent and the molecular pathways that control the transition from acute injury to chronic disease are not well defined. Currently there are no specific treatments that reduce the risk of progressing to CKD after AKI.
Preliminary investigations (not yet published) suggest that AKI causes sustained activation of the endothelin (ET) system to the long-term detriment of renal and systemic haemodynamic function. These pilot data form the basis of our project that seeks to determine whether the ET system is active in patients with AKI and, thus, represents a potential target for therapeutic intervention.
KRAKIL aims to recruit altogether 100 patients from across the emergency department, acute medical unit and inpatient wards at the Royal Infirmary. 50 of which with AKI’s and 50 matched controls with normal kidney function. We will monitor their bloods and urine for 90 days and compare the data from between the two groups.