BACKGROUND: Decreased plasma fibrinogen concentration shortly after injury is associated with higher blood transfusion needs and mortality. In North America and the UK, cryoprecipitate transfusion is the standard-of-care for fibrinogen supplementation during acute haemorrhage, which often occurs late during trauma resuscitation. Alternatively, fibrinogen concentrate (FC) can be beneficial in trauma resuscitation. However, the feasibility of its early infusion, efficacy and safety remain undetermined. The objective of this trial was to evaluate the feasibility, effect on clinical and laboratory outcomes and complications of early infusion of FC in trauma. METHODS:Fifty hypotensive (systolic arterial pressure ≤100 mm Hg) adult patients requiring blood transfusion were randomly assigned to either 6 g of FC or placebo, between Oct 2014 and Nov 2015 at a tertiary trauma centre. The primary outcome, feasibility, was assessed by the proportion of patients receiving the intervention (FC or placebo) within one h of hospital arrival. Plasma fibrinogen concentration was measured, and 28-day mortality and incidence of thromboembolic events were assessed. RESULTS: Overall, 96% (43/45) [95% CI 86-99%] of patients received the intervention within one h; 95% and 96% in the FC and placebo groups, respectively (P=1.00). Plasma fibrinogen concentrations remained higher in the FC group up to 12 h after admission with the largest difference at three h (2.9 mg dL - 1 vs. 1.8 mg dL - 1; P<0.01). The 28-day mortality and thromboembolic complications were similar between groups. CONCLUSIONS: Early infusion of FC is feasible and increases plasma fibrinogen concentration during trauma resuscitation. Larger trials are justified.
RCT Entities:
BACKGROUND: Decreased plasma fibrinogen concentration shortly after injury is associated with higher blood transfusion needs and mortality. In North America and the UK, cryoprecipitate transfusion is the standard-of-care for fibrinogen supplementation during acute haemorrhage, which often occurs late during trauma resuscitation. Alternatively, fibrinogen concentrate (FC) can be beneficial in trauma resuscitation. However, the feasibility of its early infusion, efficacy and safety remain undetermined. The objective of this trial was to evaluate the feasibility, effect on clinical and laboratory outcomes and complications of early infusion of FC in trauma. METHODS: Fifty hypotensive (systolic arterial pressure ≤100 mm Hg) adult patients requiring blood transfusion were randomly assigned to either 6 g of FC or placebo, between Oct 2014 and Nov 2015 at a tertiary trauma centre. The primary outcome, feasibility, was assessed by the proportion of patients receiving the intervention (FC or placebo) within one h of hospital arrival. Plasma fibrinogen concentration was measured, and 28-day mortality and incidence of thromboembolic events were assessed. RESULTS: Overall, 96% (43/45) [95% CI 86-99%] of patients received the intervention within one h; 95% and 96% in the FC and placebo groups, respectively (P=1.00). Plasma fibrinogen concentrations remained higher in the FC group up to 12 h after admission with the largest difference at three h (2.9 mg dL - 1 vs. 1.8 mg dL - 1; P<0.01). The 28-day mortality and thromboembolic complications were similar between groups. CONCLUSIONS: Early infusion of FC is feasible and increases plasma fibrinogen concentration during trauma resuscitation. Larger trials are justified.
Authors: Ronald Chang; Erin E Fox; Thomas J Greene; Michael D Swartz; Stacia M DeSantis; Deborah M Stein; Eileen M Bulger; Sherry M Melton; Michael D Goodman; Martin A Schreiber; Martin D Zielinski; Terence O'Keeffe; Kenji Inaba; Jeffrey S Tomasek; Jeanette M Podbielski; Savitri Appana; Misung Yi; Pär I Johansson; Hanne H Henriksen; Jakob Stensballe; Jacob Steinmetz; Charles E Wade; John B Holcomb Journal: Surgery Date: 2017-12-27 Impact factor: 3.982
Authors: Marta Barquero López; Javier Martínez Cabañero; Alejandro Muñoz Valencia; Clara Sáez Ibarra; Marta De la Rosa Estadella; Andrea Campos Serra; Aurora Gil Velázquez; Gemma Pujol Caballé; Salvador Navarro Soto; Juan Carlos Puyana Journal: J Trauma Acute Care Surg Date: 2022-03-28 Impact factor: 3.697
Authors: James Winearls; Martin Wullschleger; Elizabeth Wake; Catherine Hurn; Jeremy Furyk; Glenn Ryan; Melita Trout; James Walsham; Anthony Holley; Jeremy Cohen; Megan Shuttleworth; Wayne Dyer; Gerben Keijzers; John F Fraser; Jeffrey Presneill; Don Campbell Journal: Trials Date: 2017-05-26 Impact factor: 2.279