title: Effect of a fixed-ratio (1:1:1) transfusion protocol versus laboratory-results-guided transfusion in patients with severe trauma: a randomized feasibility trial.
abstract: BACKGROUND
  Hemorrhage coupled with coagulopathy remains the leading cause of preventable in-hospital deaths among trauma patients. Use of a transfusion protocol with a predefined ratio of 1:1:1 (1 each of red blood cells [RBC], frozen plasma [FP] and platelets) has been associated with improved survival in retrospective studies in military and civilian settings, but such a protocol has its challenges and may increase the risk of respiratory complications. We conducted a randomized controlled trial to assess the feasibility of a 1:1:1 transfusion protocol and its effect on mortality and complications among patients with severe trauma.
  
  
  METHODS
  We included 78 patients seen in a tertiary trauma centre between July 2009 and October 2011 who had hypotension and bleeding and were expected to need massive transfusion (≥ 10 RBC units in 24 h). We randomly assigned them to either the fixed-ratio (1:1:1) transfusion protocol (n = 40) or to a laboratory-results-guided transfusion protocol (control; n = 38). The primary outcome, feasibility, was assessed in terms of blood product ratios and plasma wastage. Safety was measured based on 28-day mortality and survival free of acute respiratory distress syndrome.
  
  
  RESULTS
  Overall, a transfusion ratio of 1:1:1 was achieved in 57% (21/37) of patients in the fixed-ratio group, as compared with 6% (2/32) in the control group. A ratio of 1:1 (RBC:FP) was achieved in 73% (27/37) in the fixed-ratio group and 22% (7/32) in the control group. Plasma wastage was higher with the intervention protocol (22% [86/390] of FP units v. 10% [30/289] in the control group). The 28-day mortality and number of days free of acute respiratory distress syndrome were statistically similar between the groups.
  
  
  CONCLUSIONS
  The fixed-ratio transfusion protocol was feasible in our study, but it was associated with increased plasma wastage. Larger randomized trials are needed to evaluate the efficacy of such a protocol in trauma care.
  
  
  BACKGROUND
  ClinicalTrials.gov, no. NCT00945542.
authors.affiliation: Department of General Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ont.
authors.forename: Bartolomeu
authors.initials: B
authors.lastname: Nascimento
authors.forename: Jeannie
authors.initials: J
authors.lastname: Callum
authors.forename: Homer
authors.initials: H
authors.lastname: Tien
authors.forename: Gordon
authors.initials: G
authors.lastname: Rubenfeld
authors.forename: Ruxandra
authors.initials: R
authors.lastname: Pinto
authors.forename: Yulia
authors.initials: Y
authors.lastname: Lin
authors.forename: Sandro
authors.initials: S
authors.lastname: Rizoli
mesh_terms: D000328:Adult; D001803:Blood Transfusion / Q000379:methods* / Q000401:mortality; D002985:Clinical Protocols; D058734:Exsanguination / Q000150:complications / Q000401:mortality / Q000628:therapy; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012128:Respiratory Distress Syndrome / Q000453:epidemiology / Q000209:etiology; D016019:Survival Analysis; D014193:Trauma Centers; D014947:Wounds and Injuries / Q000150:complications / Q000401:mortality / Q000628:therapy*; D055815:Young Adult