BackgroundHaemorrhage is a leading cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage. Early fibrinogen replacement is recommended by several international trauma guidelines using either fibrinogen concentrate (FC) or cryoprecipitate (Cryo). There is limited evidence to support one product over the other with widespread geographic and institutional variation in practice. This pilot trial is the first randomised controlled trial comparing FC to Cryo in traumatic haemorrhage.Methods/designThe Fibrinogen Early In Severe Trauma studY (FEISTY) is an exploratory, multicentre, randomised controlled trial comparing FC to Cryo for fibrinogen supplementation in traumatic haemorrhage. This trial will utilise thromboelastometry (ROTEM®) to guide and dose fibrinogen supplementation. The trial will recruit 100 trauma patients at four major trauma centres in Australia. Adult trauma patients with evidence of haemorrhage will be enrolled on arrival in the trauma unit and randomised to receiving fibrinogen supplementation with either FC or Cryo. The primary outcome is the differential time to fibrinogen supplementation. There are a number of predetermined secondary outcomes including: effects of the intervention on plasma fibrinogen levels, feasibility assessments and clinical outcomes including transfusion requirements and mortality.DiscussionThe optimal method for replacing fibrinogen in traumatic haemorrhage is fiercely debated. In this trial the feasibility and efficacy of fibrinogen supplementation using FC will be compared to Cryo. The results of this pilot study will facilitate the design of a larger trial with sufficient power to address patient-centred outcomes.Trial registrationClinicalTrials.gov, ID: NCT02745041. Registered 4 May 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1980-x) contains supplementary material, which is available to authorized users.

We described a feasible and acceptable family centred intervention that may be effective in promoting nutrition intake in critically ill patients. Further research is required to examine contextual factors impacting implementation of family-centred interventions, particularly those that involve active family participation and advocacy.

BACKGROUND: Haemorrhage is a major cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage, and early replacement using fibrinogen concentrate (FC) or cryoprecipitate (Cryo) is recommended by several international trauma guidelines. Limited evidence supports one product over the other, with widespread geographic and institutional variation in practice. Two previous trials have investigated the feasibility of rapid FC administration in severely injured trauma patients, with conflicting results. OBJECTIVE: To compare the time to fibrinogen replacement using FC or Cryo in severely injured trauma patients with major haemorrhage and hypofibrinogenaemia. DESIGN, SETTING, PATIENTS AND INTERVENTIONS: A multicentre controlled pilot trial in which adult trauma patients with haemorrhage were randomly assigned (1:1) to receive FC or Cryo for fibrinogen replacement, guided by FIBTEM A5 (functional fibrinogen assessment at 5 minutes after clot formation, using rotational thromboelastometry). MAIN OUTCOME MEASURES: The primary outcome was time to commencement of fibrinogen replacement. Secondary outcomes included effects of the intervention on plasma fibrinogen levels and clinical outcomes including transfusion requirements and mortality. RESULTS: Of the 100 randomly assigned patients, 62 were hypofibrinogenaemic and received the intervention (n = 37) or Cryo (n = 25). Median (interquartile range [IQR]) time to delivery of FC was 29 min (23–40 min) compared with 60 min (40–80 min) for Cryo (P = 0.0001). All 62 patients were hypofibrinogenaemic before receiving FC or Cryo (FC: median FIBTEM A5, 8 mm [IQR, 7–9 mm]; Cryo: median FIBTEM A5, 9 mm [IQR, 5–10 mm]). In the FC arm patients received a median of 3 g FC (IQR, 2–4 g), and in the Cryo arm patients received a median of 8 units of Cryo (IQR, 8–14 units). Restoration of fibrinogen levels was achieved in both arms after the intervention. Blood product transfusion, fluid resuscitation and thromboembolic complications were similar in both arms. Overall mortality was 15.3%, with more deaths in the FC arm. CONCLUSION: Fibrinogen replacement in severely injured trauma patients with major haemorrhage and hypofibrinogenaemia was achieved substantially faster using FC compared with Cryo. Fibrinogen levels increased appropriately using either product. The optimal method for replacing fibrinogen in traumatic haemorrhage is controversial. Our results will inform the design of a larger trial powered to assess patient-centred outcomes.

Objective The aim of the present study was to assess transfusion practices with the implementation of a targeted viscoelastic haemostatic assay (VHA) (ROTEM®) guided coagulation management programme into a major haemorrhage protocol for trauma patients requiring ICU admission, starting from time of arrival in the ED. Methods This retrospective observational study was conducted in a major trauma centre in Australia. One hundred and sixty‐two trauma patients admitted to the ICU between January 2013 and December 2015 with an Injury Severity Score ≥12 and who received blood products were included: 37 in the pre‐group, 48 during implementation and 77 in post‐group. The primary outcome was blood and blood product administration amounts. Results Packed red blood cell transfusion amounts did not significantly change post introduction of the ROTEM®. There was a significant increase in fibrinogen replacement between the pre‐ and post‐groups (P < 0.001), accompanied by a reduction in the use of fresh frozen plasma (P < 0.001) and prothrombinex (P < 0.001). Platelet usage in the post‐group was higher but not reaching statistical significance (P  = 0.051). Post‐implementation point‐of‐care ROTEM® testing was able to be performed in the ED in 94.8% of cases. Conclusion Although there was no overall reduction of packed red blood cell usage, a change in the pattern of administration of other blood products was observed with the implementation of a targeted VHA (ROTEM®) guided coagulation management programme. Larger studies are needed to further define the role of early VHA testing to guide correction of trauma‐induced coagulopathy and the effect on clinical outcomes.