Table 1

Inclusion and exclusion criteria

Inclusion criteriaExclusion criteria

  1. Patient affected by trauma

  2. Age between 3 months and 18 years at the time of randomisation

  3. Judged to have significant haemorrhage and predicted to require significant transfusion by the treating clinician

    OR activation of local MHP

    OR transfusion of red blood cells in the pre-hospital setting or within 6 hours of arrival at the trauma centre.

  1. Injury judged incompatible with survival

  2. Randomisation unable to occur within 6 hours of hospital admission

  3. Pregnancy

  4. Known personal or parental objection to blood products

  5. Known coagulation disorder (ie, haemophilia, von Willebrand disease)

  6. Previous fibrinogen replacement this admission

  7. Pre-trauma centre fibrinogen replacement

  8. Participation in competing study

  • MHP, major haemorrhage protocol.