title: Fibrinogen in the initial resuscitation of severe trauma (FiiRST): a randomized feasibility trial.
abstract: 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-1vs. 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.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada Barto.Nascimento@sunnybrook.ca.
authors.forename: B
authors.initials: B
authors.lastname: Nascimento
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Callum
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: H
authors.initials: H
authors.lastname: Tien
authors.affiliation: Defence Research and Development Canada, Toronto, ON, Canada.
authors.forename: H
authors.initials: H
authors.lastname: Peng
authors.affiliation: Saint Michael's Hospital, Toronto, ON, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Rizoli
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: P
authors.initials: P
authors.lastname: Karanicolas
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Alam
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: W
authors.initials: W
authors.lastname: Xiong
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Selby
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: A-M
authors.initials: AM
authors.lastname: Garzon
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: C
authors.initials: C
authors.lastname: Colavecchia
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: R
authors.initials: R
authors.lastname: Howald
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, ON, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Nathens
authors.affiliation: Montreal General Hospital, Montreal, Quebec, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Beckett
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012151:Resuscitation / Q000379:methods*; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000628:therapy*; D055815:Young Adult
chemical_list: D005340:Fibrinogen
keywords: Fibrinogen concentrate; haemorrhage management; plasma fibrinogen; trauma; trauma coagulopathy