Fibrinogen Early In Severe Trauma studY (FEISTY): results from an Australian multicentre randomised controlled pilot trial.

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.

Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial.

BACKGROUND: Haemorrhage 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/DESIGN: The 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov, ID: NCT02745041 . Registered 4 May 2016.

Fibrinogen in traumatic haemorrhage: A narrative review.

Haemorrhage in the setting of severe trauma is associated with significant morbidity and mortality. There is increasing awareness of the important role fibrinogen plays in traumatic haemorrhage. Fibrinogen levels fall precipitously in severe trauma and the resultant hypofibrinogenaemia is associated with poor outcomes. Hence, it has been postulated that early fibrinogen replacement in severe traumatic haemorrhage may improve outcomes, although, to date there is a paucity of high quality evidence to support this hypothesis. In addition there is controversy regarding the optimal method for fibrinogen supplementation. We review the current evidence regarding the role of fibrinogen in trauma, the rationale behind fibrinogen supplementation and discuss current research.

Characteristics and outcomes of patients administered blood in the prehospital environment by a road based trauma response team.

OBJECTIVE: To describe the characteristics, clinical interventions and the outcomes of patients administered packed red blood cells (pRBCs) by a metropolitan, road based, doctor-paramedic trauma response team (TRT). METHODS: A retrospective cohort study examining 18 months of historical data collated by the Queensland Ambulance Service TRT, the Pathology Queensland Central Transfusion Laboratory, the Royal Brisbane and Women's Hospital and the Princess Alexandra Hospital Trauma Services was undertaken. RESULTS: Over an 18-month period (1 January 2011 to 30 June 2012), 71 trauma patients were administered pRBCs by the TRT. Seven patients (9.9%) died on scene and 39 of the 64 patients (60.9%) transported to hospital survived to hospital discharge. 57 (89.1%) of the transported patients had an Injury Severity Score (ISS) > 15, with a mean ISS, Revised Trauma Score (RTS) and Trauma-Injury Severity Score of 32.11, 4.70 and 0.57, respectively. No patients with an RTS < 2 survived to hospital discharge. 53 patients (82.8%) received additional pRBCs in hospital with 17 patients (26.6%) requiring greater than 10 units pRBCs in the first 24 h. 47 patients (73.4%) required surgical or interventional radiological procedures in the first 24 h. CONCLUSIONS: There is a potential role for prehospital pRBC transfusions in an integrated civilian trauma system. The RTS calculated using the initial set of observations may be a useful tool in determining in which patients the administration of prehospital pRBC transfusions would be futile.

Independence of 'reaction to hypothetical contradiction' from other measures of delusional ideation.

BACKGROUND: Given the increasing pressure on Community Mental Health Teams to provide effective services for people with serious mental health problems and the relative scarcity of clinicians working therapeutically with this group, the ongoing search for reliable prognostic factors has both economic and clinical implications. Although previously somewhat overlooked, 'reaction to hypothetical contradiction' (RTHC) has been described as a potential predictor of amenability to psychological treatment for people holding delusional beliefs. METHOD: A one-way between-groups design was used to explore the independence of RTHC (accepting vs. non-accepting) from a range of other clinical variables, using a mixed-diagnosis group of 50 people holding delusional beliefs. RESULTS: Associations were found between RTHC and a range of other clinical variables, including the existence of perceptual experiences and the impact and extent of delusional beliefs. These factors can be difficult to measure, and it is argued that RTHC may be easier to assess than these other variables. RTHC was found to be independent from other variables such as insight, degree of conviction, degree of preoccupation, anxiety and depression. IMPLICATIONS: Previous research has shown that RTHC is a potential predictor of both spontaneous recovery and response to treatment for people holding delusional beliefs and that assessment of RTHC should be incorporated into initial screening procedures for cognitive-behaviour therapy. The current research found that RTHC was associated with the extent to which delusional beliefs influence thoughts, behaviour and distress levels. One of the major implications of this study is that evaluation of RTHC at initial screening assessments may be important as it provides information not available from mental-state assessments and assessment of insight.