The effects of fibrinogen supplementation on trauma haemorrhage
Research type
Research Study
Full title
A laboratory sub study evaluating the effects of early administration of fibrinogen supplementation in adults with major traumatic haemorrhage.
IRAS ID
239581
Contact name
Nicola Curry
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Research Summary
As many as 4 in every 10 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. This study will look at the in vitro/ex vivo effects of fibrinogen supplementation on clotting measurements in adult trauma patients with major bleeding. It will also explore the different effects of the two forms of fibrinogen supplementation – fibrinogen concentrate and cryoprecipitate.
Blood samples have been taken from participants recruited to the FEISTY study at several time points from the time of admission until the end of active bleeding. These blood samples will have been processed into plasma samples and then stored immediately and will be batched and analysed as part of this sub study. FEISTY has received ethical approval for blood sample collection and analysis and transfer of the plasma samples to the UK.
This study aims to understand the effects on the plasma of the use of two forms of fibrinogen therapy - fibrinogen concentrate and cryoprecipitate. FEISTY is a trauma RCT conducted in Australia where adult trauma patients who were admitted to several trauma hospitals were treated with either: a)standard therapy plus fibrinogen concentrate or b) standard therapy plus cryoprecipitate. This laboratory substudy aims to explore the effects of these treatments on clot strength and fibrin formation and whether there are any differential effects between the forms of fibrinogen therapy.Summary of Results
This study looked at how well blood clots could form in the blood samples taken from patients who had suffered a severe traumatic injury (such as a road traffic accident) and who were being treated for major bleeding. We know that one of the blood clotting proteins - called fibrinogen - can fall rapidly in people who bleed heavily after injury, and there are two main types of transfusion treatment that can be used to treat a low blood fibrinogen levels: fibrinogen concentrate and cryoprecipitate. We compared the effects of these two transfusion treatments on how they changed the strength of a blood clot and how stable the clots were once they were formed. We showed that both treatments increased blood fibrinogen levels well. We showed that there were some differences between the treatments, and that the fibrin clot formed with cryoprecipitate had stronger fibrin strands and was more resistant to clot breakdown when compared to fibrinogen concentrate. This study was undertaken on a small number of patients and more work is needed.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
18/EM/0056
Date of REC Opinion
15 Feb 2018
REC opinion
Favourable Opinion