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

2021 ◽  
Vol 23 (1) ◽  
pp. 32-46
Author(s):  
James Winearls ◽  
◽  
Martin Wullschleger ◽  
Elizabeth Wake ◽  
Zoe McQuilten ◽  
...  

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.

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017003 ◽  
Author(s):  
Nicolas Marjanovic ◽  
Denis Frasca ◽  
Karim Asehnoune ◽  
Catherine Paugam ◽  
Sigismond Lasocki ◽  
...  

IntroductionSevere trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients.Methods and analysisThis multicentre randomised controlled and open-label trial will include patients suffering from severe trauma who are admitted within the first 24 hours, who require invasive mechanical ventilation to longer than 48 hours. Their tracheal cuff pressure will be monitored either once every 8 hours (control group) or continuously using a pneumatic device (intervention group). The primary end point is the proportion of patients that develop VAP in the intensive care unit (ICU) at day 28. The secondary end points include the proportion of patients that develop VAP in the ICU, early (≤7 days) or late (>7 days) VAP, time until the first VAP diagnosis, the number of ventilator-free days and antibiotic-free days, the length of stay in the ICU, the proportion of patients with ventilator-associated events and that die during their ICU stay.Ethics and disseminationThis protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registrationClinical TrialsNCT02534974


Injury ◽  
2017 ◽  
Vol 48 (9) ◽  
pp. 1964-1971 ◽  
Author(s):  
Mehdi Mezidi ◽  
Mehdi Ould-Chikh ◽  
Pauline Deras ◽  
Camille Maury ◽  
Orianne Martinez ◽  
...  

2016 ◽  
Vol 44 (12) ◽  
pp. 465-465
Author(s):  
Christopher Wybourn ◽  
April Mendoza ◽  
Mitchell Cohen ◽  
Rachael Callcut

2020 ◽  
Author(s):  
Michel Teuben ◽  
Arne Hollman ◽  
Taco J. Blokhuis ◽  
Roman Pfeifer ◽  
Roy Spijkerman ◽  
...  

Abstract Background Inadequate activation of the innate immune system after trauma can lead to severe complications such as Acute Respiratory Distress Syndrome and Multiple Organ Dysfunction Syndrome. The spleen is thought to modulate the cellular immune system. Furthermore, splenectomy is associated with improved outcome in severely injured trauma patients. We hypothesized that a splenectomy alters the cellular immune response in polytrauma.Methods All adult patients with an ISS ≥ 16 and suffering from splenic or hepatic injuries were selected from our prospective trauma database. Absolute leukocyte numbers in peripheral blood were measured. White blood cell kinetics during the first 14 days were compared between splenectomized patients, patients treated surgically for liver trauma and nonoperatively treated individuals.Results A total of 129 patients with a mean ISS of 29 were included. Admission characteristics and leukocyte numbers were similar in all groups, except for slightly impaired hemodynamic status in patients with operatively treated liver injuries. On admission, leukocytosis occurred in all groups. During the first 24 hours, leukopenia developed gradually, although significantly faster in the operatively treated patients. Thereafter, leukocyte levels normalized in all nonoperatively treated cases whereas leukocytosis persisted in operatively treated patients. This effect was significantly more prominent in splenectomized patients than all other conditions. Conclusions This study demonstrates that surgery for intra-abdominal injuries is associated with an early drop in leucocyte numbers in peripheral blood. Moreover, splenectomy in severely injured patients is associated with an altered cellular immune response reflected by a persistent state of prominent leukocytosis after trauma.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Chun Yuet Khoo ◽  
Terence Yi Song Liew ◽  
Sachin Mathur

Abstract Background Hybrid operating theatres (OT) allow for simultaneous interventional radiology and operative procedures, serving as a one-stop facility for the treatment of severely injured patients. Several countries have adopted the use of the hybrid OT however their clinical impact in improving efficiency and quality of care remains unclear. This study systematically reviews the clinical impact of the hybrid OT for treatment of the severely injured. Methods A literature review of the PubMed, Embase and Cochrane databases was performed to identify all published articles in English, from 1st January 2000 to 31st December 2020, reporting on the impact of a hybrid OT for severe trauma. Articles were also reviewed for references of interest. Results Five studies reporting the clinical impact of the hybrid OT, in a total of 951 patients, were shortlisted. All were cohort studies that compared patient outcomes in the hybrid OT versus a conventional group. Out of 3 studies that assessed timeliness to intervention, one reported shorter time associated with the hybrid OT, while the other two reported no difference. Mortality outcomes were reported in 4 studies and showed no significant difference associated with treatment in the hybrid OT. Two studies revealed shorter total procedure times associated with the hybrid OT. Two out of 3 studies that evaluated blood transfusion requirements reported decreased transfusion rates in the hybrid OT group. Only 1 study examined complication rates and demonstrated morbidity benefits associated with the hybrid OT. Conclusion Establishment of a hybrid OT requires a significant capital investment as well as a highly functioning multi-disciplinary team. The cost–benefit ratio remains unclear. Future studies, preferably in the form of clinical trials, are required to evaluate its usefulness in improving timeliness to definitive haemorrhage control and outcomes in severe trauma.


2017 ◽  
Vol 2017 ◽  
pp. 1-12 ◽  
Author(s):  
David Heftrig ◽  
Ramona Sturm ◽  
Elsie Oppermann ◽  
Kerstin Kontradowitz ◽  
Katrin Jurida ◽  
...  

Objective. Trauma patients (TP) frequently develop an imbalanced immune response that often causes infectious postinjury complications. Monocytes show a diminished capability of both producing proinflammatory cytokines and antigen presentation after trauma. TLR2, TLR4, and TLR9 recognize pathogens and subsequently activate monocytes. While there are conflictive data about TLR2 and TLR4 expression after trauma, no studies about the expression of TLR2, TLR4, TLR9, and HLA-DR on monocytes from TP after their secondary ex vivo-in vitro “hit” have been reported.Methods/Results. Ex vivo-in vitro lipopolysaccharide- (LPS-) stimulated blood from TP showed diminished interleukin- (IL-) 1β-release in TP for five postinjury days compared to healthy volunteers (HV). The recovery was observed at day 5. In parallel, monocytes from TP showed an impaired capability of TLR2, TLR4, and TLR9 expression after secondary stimulation compared to HV, while the measurement of unstimulated samples showed significant reduction of TLR4 and TLR9 at ED. Furthermore, HLA-DR decreased after trauma and was even more profound by stimulation of monocytes. Ratio of monocytes to leukocytes was significantly increased at days 6 and 7 after trauma compared to HV.Conclusion. Impaired expression of TLRs and HLA-DR in acute inflammatory conditions may be responsible for the well-described monocyte paralysis after severe trauma.


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Carolina Ruiz ◽  
Max Andresen

Coagulopathy is frequently present in trauma. It is indicative of the severity of trauma and contributes to increased morbidity and mortality. Uncontrolled bleeding is the most frequent preventable cause of death in trauma patients reaching hospital alive. Coagulopathy in trauma has been long thought to develop as a result of hemodilution, acidosis, and hypothermia often related to resuscitation practices. However, altered coagulation tests are already present in 25–30% of severe trauma patients upon hospital arrival before resuscitation efforts. Acute coagulopathy associated with trauma (ACoT) has been recognized in recent years as a distinct entity associated with increased mortality, morbidity, and transfusion requirements. Transfusion and nontransfusion strategies aimed at correcting ACoT, particularly in patients with massive bleeding and massive transfusion, are currently available. Early administration of tranexamic acid to bleeding trauma patients safely reduces the risk of death. It has been proposed that early aggressive blood product transfusional management of ACoT with a red blood cell : plasma : platelets ratio close to 1 : 1 : 1 could result in decreased mortality from uncontrolled bleeding.


2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Michel Paul Johan Teuben ◽  
Arne Hollman ◽  
Taco Blokhuis ◽  
Roman Pfeifer ◽  
Roy Spijkerman ◽  
...  

Abstract Background Inadequate activation of the innate immune system after trauma can lead to severe complications such as Acute Respiratory Distress Syndrome and Multiple Organ Dysfunction Syndrome. The spleen is thought to modulate the cellular immune system. Furthermore, splenectomy is associated with improved outcome in severely injured trauma patients. We hypothesized that a splenectomy alters the cellular immune response in polytrauma. Methods All adult patients with an ISS ≥ 16 and suffering from splenic or hepatic injuries were selected from our prospective trauma database. Absolute leukocyte numbers in peripheral blood were measured. White blood cell kinetics during the first 14 days were compared between splenectomized patients, patients treated surgically for liver trauma and nonoperatively treated individuals. Results A total of 129 patients with a mean ISS of 29 were included. Admission characteristics and leukocyte numbers were similar in all groups, except for slightly impaired hemodynamic status in patients with operatively treated liver injuries. On admission, leukocytosis occurred in all groups. During the first 24 h, leukopenia developed gradually, although significantly faster in the operatively treated patients. Thereafter, leukocyte levels normalized in all nonoperatively treated cases whereas leukocytosis persisted in operatively treated patients. This effect was significantly more prominent in splenectomized patients than all other conditions. Conclusions This study demonstrates that surgery for intra-abdominal injuries is associated with an early drop in leucocyte numbers in peripheral blood. Moreover, splenectomy in severely injured patients is associated with an altered cellular immune response reflected by a persistent state of prominent leukocytosis after trauma.


Author(s):  
Reviewer Joseph DuBose ◽  
Jonathan Morrison ◽  
Megan Brenner ◽  
Laura Moore ◽  
John B Holcomb ◽  
...  

ABSTRACT Introduction:  The introduction of low profile devices designed for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) after trauma has the potential to change practice, outcomes and complication profiles related to this procedure. Methods: The AAST Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry was utilized to identify REBOA patients from 16 centers -comparing presentation, intervention and outcome variables for those REBOA via traditional 11-12 access platforms and trauma-specific devices requiring only 7 F access. Results:From Nov 2013-Dec 2017, 242 patients with completed data were identified, constituting 124 7F and 118 11-12F uses. Demographics of presentation were not different between the two groups, except that the 7F patients had a higher mean ISS (39.2 34.1, p = 0.028). 7F device use was associated with a lower cut-down requirement for access (22.6% vs. 37.3%, p = 0.049) and increased ultrasound guidance utilization (29.0% 23.7%, p = 0.049). 7F device afforded earlier aortic occlusion in the course of resuscitation (median 25.0 mins vs. 30 mins, p = 0.010), and had lower median PRBC (10.0 vs. 15.5 units, p = 0.006) and FFP requirements (7.5 vs. 14.0 units, p = 0.005). 7F patients were more likely to survive 24 hrs (58.1% vs. 42.4%, p = 0.015) and less likely to suffer in-hospital mortality (57.3% vs. 75.4%, p = 0.003). Finally, 7F device use was associated with a 4X lower rate of distal extremity embolism (20.0% vs. 5.6%, p = 0.014;OR 95% CI 4.25 [1.25-14.45]) compared to 11-12F counterparts. Conclusion: The introduction of trauma specific 7F REBOA devices appears to have influenced REBOA practices, with earlier utilization in severely injured hypotensive patients via less invasive means that are associated with lower transfusion requirements fewer thrombotic complications and improved survival. Additional study is required to determine optimal REBOA utilization.


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