title: Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays.
abstract: BACKGROUND
  Massive transfusion protocols (MTPs) have become standard of care in the management of bleeding injured patients, yet strategies to guide them vary widely. We conducted a pragmatic, randomized clinical trial (RCT) to test the hypothesis that an MTP goal directed by the viscoelastic assay thrombelastography (TEG) improves survival compared with an MTP guided by conventional coagulation assays (CCA).
  
  
  METHODS
  This RCT enrolled injured patients from an academic level-1 trauma center meeting criteria for MTP activation. Upon MTP activation, patients were randomized to be managed either by an MTP goal directed by TEG or by CCA (ie, international normalized ratio, fibrinogen, platelet count). Primary outcome was 28-day survival.
  
  
  RESULTS
  One hundred eleven patients were included in an intent-to-treat analysis (TEG = 56, CCA = 55). Survival in the TEG group was significantly higher than the CCA group (log-rank P = 0.032, Wilcoxon P = 0.027); 20 deaths in the CCA group (36.4%) compared with 11 in the TEG group (19.6%) (P = 0.049). Most deaths occurred within the first 6 hours from arrival (21.8% CCA group vs 7.1% TEG group) (P = 0.032). CCA patients required similar number of red blood cell units as the TEG patients [CCA: 5.0 (2-11), TEG: 4.5 (2-8)] (P = 0.317), but more plasma units [CCA: 2.0 (0-4), TEG: 0.0 (0-3)] (P = 0.022), and more platelets units [CCA: 0.0 (0-1), TEG: 0.0 (0-0)] (P = 0.041) in the first 2 hours of resuscitation.
  
  
  CONCLUSIONS
  Utilization of a goal-directed, TEG-guided MTP to resuscitate severely injured patients improves survival compared with an MTP guided by CCA and utilizes less plasma and platelet transfusions during the early phase of resuscitation.
authors.affiliation: *Department of Surgery, University of Colorado, Denver, CO†Department of Surgery, Denver Health Medical Center, Denver, CO‡Department of Pediatrics, University of Colorado, Denver, CO§Research Laboratory, Bonfils Blood Center, Denver, CO¶Colorado School of Public Health, University of Colorado, Denver, CO.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Gonzalez
authors.forename: Ernest E
authors.initials: EE
authors.lastname: Moore
authors.forename: Hunter B
authors.initials: HB
authors.lastname: Moore
authors.forename: Michael P
authors.initials: MP
authors.lastname: Chapman
authors.forename: Theresa L
authors.initials: TL
authors.lastname: Chin
authors.forename: Arsen
authors.initials: A
authors.lastname: Ghasabyan
authors.forename: Max V
authors.initials: MV
authors.lastname: Wohlauer
authors.forename: Carlton C
authors.initials: CC
authors.lastname: Barnett
authors.forename: Denis D
authors.initials: DD
authors.lastname: Bensard
authors.forename: Walter L
authors.initials: WL
authors.lastname: Biffl
authors.forename: Clay C
authors.initials: CC
authors.lastname: Burlew
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Johnson
authors.forename: Fredric M
authors.initials: FM
authors.lastname: Pieracci
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Jurkovich
authors.forename: Anirban
authors.initials: A
authors.lastname: Banerjee
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Silliman
authors.forename: Angela
authors.initials: A
authors.lastname: Sauaia
mesh_terms: D000328:Adult; D001778:Blood Coagulation Disorders / Q000209:etiology* / Q000628:therapy*; D001803:Blood Transfusion / Q000592:standards*; D003120:Colorado; D005260:Female; D006489:Hemostatic Techniques; D006801:Humans; D015601:Injury Severity Score; D008297:Male; D008875:Middle Aged; D012151:Resuscitation / Q000379:methods*; D015996:Survival Rate; D013916:Thrombelastography / Q000379:methods*; D014193:Trauma Centers; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000150:complications