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Study identifier: NCT05449834 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Fibrinogen Early In Severe Trauma StudY II

Condition: Trauma · Haemorrhagic Shock · Coagulopathy  ·  Sponsor: Australian and New Zealand Intensive Care Research Centre

PhasePhase 3
Planned participants900
Who can joinAll sexes, 18 Years to 100 Years
Healthy volunteersNo

About this study

Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes. Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regio…

This description comes directly from the study's public registry record.

Talk to the study team

James Winearls, MBBS  ·  +61399030379  ·  james.winearls@health.qld.gov.au

Bridget Ady  ·  +61399056643  ·  bridget.ady@monash.edu

Always discuss trial participation with your own doctor first.

Locations (24)

John Hunter HospitalNewcastle, New South Wales, AustraliaRecruiting
St Vincent's HospitalSydney, New South Wales, AustraliaRecruiting
Royal Prince Alfred HospitalSydney, New South Wales, AustraliaRecruiting
Royal North Shore HospitalSydney, New South Wales, AustraliaRecruiting
Westmead HospitalSydney, New South Wales, AustraliaRecruiting
Liverpool HospitalSydney, New South Wales, AustraliaRecruiting
Royal Darwin HospitalDarwin, Northern Territory, AustraliaRecruiting
Royal Brisbane and Women's HospitalBrisbane, Queensland, AustraliaRecruiting
Princess Alexandra HospitalBrisbane, Queensland, AustraliaRecruiting
Cairns HospitalCairns, Queensland, AustraliaRecruiting
Gold Coast University HospitalGold Coast, Queensland, AustraliaRecruiting
Rockhampton HospitalRockhampton, Queensland, AustraliaRecruiting

+ 12 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05449834