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.
Background The purpose of this scoping review was to ascertain how ‘telehealth’ is utilised within health care, from pre hospital to admission, discharge and post discharge, with patients who have suffered major trauma. Methods A scoping review of the literature published in English since 1980 was conducted using MEDLINE, Ovid EMBASE, PsychINFO, CINAHL, Austhealth, Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane library) and Web of Science MEDLINE and MEBASE to identify relevant studies. Results We included 77 eligible studies with both randomised controlled trial and cohort design methodology. A variety of trauma was included such as traumatic brain injuries ( n = 52; 67.5%), spinal cord injury ( n = 14; 18.2%) and multi-trauma ( n = 9; 11.7%) to both adult ( n = 38) and paediatric ( n = 32) participants. Telehealth is used in pre-hospital and acute-care settings ( n = 11; 14.3%) to facilitate assessment, and in rehabilitation and follow-up ( n = 61; 79.2%) to deliver therapy. Effects on health were reported the most ( n = 46), with no negative outcomes. The feasibility of telehealth as a delivery mode was established, but coordination and technical issues are barriers to use. Overall, both patients and clinicians were satisfied using this mode of delivery. Conclusion This review demonstrates how telehealth is utilised across a spectrum of patients with traumatic injuries and to facilitate delivery of therapy, specialist consultations and assessments, with many studies reporting improvements to health. There is a paucity of high-quality rigorous research, which makes replication of findings and uptake of the intervention problematic. Future telehealth and trauma research should focus on the quality and reproducibility of telehealth interventions and the economic feasibility of using this platform to deliver trauma care.
Background: There is ambiguity regarding anatomical site of embolization, frequency of follow-up scans and splenic function following angioembolisation in the management of high grade blunt splenic injury. A splenic salvage pathway in patients who are hemodynamically stable or resuscitated to stability was introduced across two trauma centres. The aims of this project were: to develop a clinical pathway to manage hemodynamically stable blunt splenic injury patients and to determine rates of splenic salvage for patients with high grade splenic injury, assess complications and splenic function following completion of the pathway.Methods: Prospective study over a period of 24 months. Data was collected to evaluate rates of splenic salvage, complications and function of the spleen following angioembolisation.Results: Thirty-three patients, predominantly males (n=29) between the ages of 14-85 years, were included in the study. Three (9%) with grade V injury, underwent angioembolization on admission but required splenectomy as an inpatient. On day 14, all patients (n=30) with splenic salvage underwent blood tests, with 3 patients (9%) receiving vaccination for altered red cell morphology. The introduction of clinical pathway led to an increase in our splenic salvage rate to 91%.Conclusions: We believe that introduction of proposed clinical pathway may result in increased rates of splenic salvage with preservation of function following angioembolisation.
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