FEISTY – Fibrinogen Early In Severe Trauma study

Is it quicker to administer Fibrinogen concentrate than cryoprecipitate?

Grant ID: EMPJ-357R25-2016

Lay Summary

This clinical trial aims to improve the quality of the resuscitation of patients with traumatic haemorrhage. We are enrolling 100 patients from four major trauma centres in Queensland. Patients admitted with severe traumatic bleeding will be given either Fibrinogen concentrate or cryoprecipitate. Time to administration of these products and effects on blood fibrinogen levels will be measured. We are using innovative technology to identify hypofibrinogenaemia; we will provide data to define the optimal method of replacement and monitoring of the end points of resuscitation; and provide data on the role of fibrinogen concentrate and its use in traumatic haemorrhage. We are also exposing a broad range of ED physicians to potential practice changing research that may be translated to use in other patient groups with critical bleeding.

More than 7000 Australians are treated for severe trauma every year. Major bleeding in the setting of trauma is associated with poor outcomes and increased rates of death. Severe trauma causes a decrease in the factors within the blood that helps clots to form and stop bleeding. This loss of clotting factors is associated with worse outcomes and it is proposed that early replacement of these factors may reduce bleeding and improve outcomes. Fibrinogen is one of the key clotting factors that needs to be replaced in severe traumatic bleeding. Currently fibrinogen is replaced using cryoprecipitate; a blood product obtained from healthy volunteer donors. This is a precious resource that is stored frozen in the blood bank; it can take a long time to administer and place significant strain on blood banks. Fibrinogen concentrate (FC) is an alternative product used to assist in blood clotting. It is stored in powder form, can be reconstituted at the bedside and given quickly. The study will investigate whether it is quicker to administer FC than cryoprecipitate, which will reduce haemorrhage and improve outcomes. With positive impact for both large urban metropolitan areas and remote isolated communities.


Outcomes

The outcomes from this trial are pending publication. In conference presentations, the team has reported that they found fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker using Fibrinogen Concentrate compared to Cryoprecipitate.

Based on the research, the team is now running the multi-site FEISTY II trial and the FEISTY Junior trial. The FEISTY II trial involves a collaboration with the CRYOSTAT 2 team in the United Kingdom.


Leveraged Funds

- In-kind: CSL Behring - Fibrinogen Concentrate (500g): ~ $360,000
- In-kind: TEM International - ROTEM Sigma and Reagents: ~$138,000
- In-kind: Gold Coast University Hospital - staff time: $200,000
- National Blood Authority (Grant ID 127): $190,000
- Gold Coast Hospital and Health Service Grant: $140,423
- Gold Coast Hospital and Health Service Grant: $132,000
- Townsville Hospital and Health Service Grant: $9,653


Dissemination

Journals:
- Winearls J., Campbell D., Hurn C., Furyk J., Ryan G., Trout M., Walsham J., Holley A., Shuttleworth M., Dyer W., Keijzers G., Presneill J., Fraser J.F., Wullschleger M., “Fibringoen in traumatic haemorrhage: A naarative review”, Injury, 2016;48(2): 230 - 242.
- Winearls J., Reade M., Miles H., Bulmer A., Campbell D., Gorlinger K., Fraser J.F., “Targeted coagulation management in severe trauma: the controversies and the evidence”, Anethesia-analgesia, 2016; 123(4): 910 - 924.
-Winearls, J, Wullschleger, M, Wake, E, Hurn, C, Furyk, C, Ryan, G, Trout, M, Walsham, J, Holley, A, Cohen, J, SHuttleworth, M, Dyer, W, Keijzers, G, Fraser, JF, Presneill, J, Campbell, D., “Fibrinogern Early In Severe Trauma studY (FEISTY) : study protocol for a randomised controlled trial”, Trials, 2017;18:241., doi: 10.1186/s13063-017-1980-x
- Winearls, J., Mitra, B., Reade, M.C., “Haemotherapy algorithm for the management of trauma-induced coagulopathy: an Australian perspective”, Current Opinion in Anaesthesiology, 2017; 30(2): 265 - 276,. ISSN 0952-7907.
-Winearls, J., Campbell, D., Hurn, C., Furyk, J., Ryan, G., Trout, M., Walsham, J., Holley, A., Shuttleworth, M., Dyer, W. and Keijzers, G., “Fibrinogen in traumatic haemorrhage: A narrative review”, Injury, 2017; 48(2): 230-242. doi: 10.1016/j.injury.2016.12.012
-Reade, MC, Winearls, J., “Coagulation – Evidence, new methods and current practice of point-of-care coagulation testing in major haemorrhage”, Australasian Anaesthesia ed., Riley R., 2017; 117 – 134, Australian and New Zealand College of Anaesthetists, Ellikon, Fitzroy, Victoria

Conference:
2016 Royal College of Pathologists Australia Targeted Coagulation Management in Severe Trauma (Oral), Dr James Winearls
SWAN Trauma Conference, Liverpool Hospital, Sydney, July
World Trauma Congress, India, August FEISTY: Fibrinogen Early In Severe Trauma study Fibrinogen Concentrate vs. Cryoprecipitate in Severe Traumatic Hemorrhage
World Trauma Congress, India, August Evaluation of Fibrinogen Concentrate use in Severe Traumatic Haemorrhage - Initial Observational Data
2017 Neuro-anaethesia and Trauma Special Interest Group Point of Care in Massive Transfusion
Inaugural Perioperative Patient Blood Management Symposium, Brisbane, 18 Feb
Transfusion update conference, April, Transfusion update conference - How I use Transfusion Laboratory Information in Clinical Practice Dr James Winearls
Transfusion update conference, April, Is Fibrinogen the death of Cryo? (invited) Dr Philip Mondy
Transfusion update conference, April, How I use Transfusion Laboratory Information in Clinical Practice Dr James Winearls
SWAN Conference Red Blankets and ROTEM , Elizabeth Wake
Resus @ the Park, June Targeted Coagulation in Severe Trauma
ACEM Queensland, Autumn Symposium, ROTEM in Traumatic Haemorrhage
ACEM Winter Symposium, South Australia, 36-29 July, Fibrinogen Early In Severe Trauma study (FEISTY): A study protocol for a pilot randomised controlled trial comparing Fibrinogen Concentrate to Cryoprecipitate in traumatic haemorrhage, Dr Donald Campbell
EMF Symposium, August 2018, Brisbane New Paradigms in Critical Care -Trauma, Dr Donald Campbell
World Congress of Surgery, Basel, Aug 2017 Fibrinogen replacement in traumatic haemorrhage, Dr Martin Wullschleger et al.
International Society of Surgery/World Congress of Surgery, August 2017 Fibrinogen Concentrate - Good new friend?, Dr James Winearls
PBM Symposium, Vienna, September 2017 Targeted Coagulation Management in Trauma
Patient blood management symposium, Austria, September, Invited lecture - Management of Trauma Haemorrhage
Anaesthetic Conference (ANZCA), Pop up Simulation in relation to trauma/FEISTY
ANZCA Joint Neuroanaesthesia and Trauma Special Interest Group, September, Point of Care Testing and Massive Transfusion
Annual Scientific Meeting of the Haematology Society of Australia and New Zealand 2017, Sydney, October 2017
Asia-Pacific Extracorporeal Life Support Organization (APELSO) Conference 2017, Gold Coast, October, Invited Lecture and Expert Panel Debate - Trauma ECMO
Caboolture Grand Round, September 2017, Invited speaker
HAA, October Expert Panel Debate - Fixed Ratio MTP vs Targeted MTP
Trauma Symposium - November, Invited Lecture, Trauma Coagulation and Sepsis
Gold Coast Research Week Conference, November 2017
ACEM ASM, Sydney, FEISTY Implementation
2018
Queensland Trauma Symposium, Royal Brisbane & Women's Hospital, 22-23 February 2018
RBWH Trauma Symposium, Feb, FEISTY Talk
PBM Meeting Bangkok, Invited Speaker
QLD Trauma Symposium, February Invited Speaker
QLD Patient Blood Management Symposium, February, Invited Speaker
ANZICS CTG (Closed Session), March, FEISTY Pilot Preliminary Results - Invited Speaker
ARCBS Webinar, April , Invited Speaker
Anaesthetic Conference (ANZCA) FEISTY Primary Outcome, Dr James Winearls
College of Intensive Care Meeting VHA Workshop, June, Invited Speaker
ATS conference, Fibrinogen Replacement in Traumatic Haemorrhage; Blood Product usage
Australian Trauma Society, FEISTY Primary Outcome, Dr Donald Campbell
SWAN Conference Implementation and Recruitment of the Fibrinogen Early In Severe Trauma studY, Elizabebth Wake et al.
ANZICS CTG, Sydney, August FEISTY II Protocol Presentation - Invited Speaker
World Congress, September FEISTY Primary Outcome, Dr James Winearls
Gold Coast University Hospital Research Week, November, FEISTY Primary Outcome (Poster)
Gold Coast University Hospital Research Week, November. FEISTY Implementation and Recruitment (Poster)


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Amount Awarded
$292,937


Program


Grant Scheme


Status
Completed


Principal Investigator:
Dr Don Campbell


Co Investigators:
Dr Catherine Hurn
Dr James Winearls
Dr Martin Wullschleger


Associate Investigators:
Dr Jeremy Furyk
Dr Glenn Ryan
Prof Jeffrey Presneill
Prof John Fraser
A/Prof Gerben Keijzers
Megan Shuttleworth
Dr Wayne Dyer


Institution


Collaborating Institutions


Links

  • Linked EMF grant: Fibrinogen Early In Severe Trauma studY II (FEISTY II)
  • Linked EMF grant: Fibrinogen Early In Severe Trauma in children studY (FEISTY Junior)
  • FEISTY website

  • Media

  • Media release [April 2017]
  • CONTACT US +61 7 3720 5700 info@emfoundation.org.au Suite 1B, Terraces, 19 Lang Parade, Milton Qld 4064