Goal-directed hemostatic resuscitation of trauma-induced coagulopathy a pragmatic randomized clinical trial comparing a viscoelastic assay to conventional coagulation assays

Eduardo Gonzalez, Ernest E. Moore, Hunter B. Moore, Michael P. Chapman, Theresa L. Chin, Arsen Ghasabyan, Max V. Wohlauer, Carlton C. Barnett, Denis D. Bensard, Walter L. Biffl, Clay C. Burlew, Jeffrey L. Johnson, Fredric M. Pieracci, Gregory Jurkovich, Anirban Banerjee, Christopher C. Silliman, Angela Sauaia

Research output: Contribution to journalArticle

187 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1051-1059
Number of pages9
JournalAnnals of Surgery
Volume263
Issue number6
DOIs
StatePublished - Jan 1 2016
Externally publishedYes

Fingerprint

Pragmatic Clinical Trials
Thrombelastography
Hemostatics
Resuscitation
Randomized Controlled Trials
Wounds and Injuries
Survival
Platelet Transfusion
International Normalized Ratio
Trauma Centers
Standard of Care
Platelet Count
Fibrinogen

Keywords

  • Coagulopathy
  • Fibrinolysis
  • Goal-directed
  • Resuscitation
  • Thrombelastography
  • Transfusion

ASJC Scopus subject areas

  • Surgery

Cite this

Goal-directed hemostatic resuscitation of trauma-induced coagulopathy a pragmatic randomized clinical trial comparing a viscoelastic assay to conventional coagulation assays. / Gonzalez, Eduardo; Moore, Ernest E.; Moore, Hunter B.; Chapman, Michael P.; Chin, Theresa L.; Ghasabyan, Arsen; Wohlauer, Max V.; Barnett, Carlton C.; Bensard, Denis D.; Biffl, Walter L.; Burlew, Clay C.; Johnson, Jeffrey L.; Pieracci, Fredric M.; Jurkovich, Gregory; Banerjee, Anirban; Silliman, Christopher C.; Sauaia, Angela.

In: Annals of Surgery, Vol. 263, No. 6, 01.01.2016, p. 1051-1059.

Research output: Contribution to journalArticle

Gonzalez, E, Moore, EE, Moore, HB, Chapman, MP, Chin, TL, Ghasabyan, A, Wohlauer, MV, Barnett, CC, Bensard, DD, Biffl, WL, Burlew, CC, Johnson, JL, Pieracci, FM, Jurkovich, G, Banerjee, A, Silliman, CC & Sauaia, A 2016, 'Goal-directed hemostatic resuscitation of trauma-induced coagulopathy a pragmatic randomized clinical trial comparing a viscoelastic assay to conventional coagulation assays', Annals of Surgery, vol. 263, no. 6, pp. 1051-1059. https://doi.org/10.1097/SLA.0000000000001608
Gonzalez, Eduardo ; Moore, Ernest E. ; Moore, Hunter B. ; Chapman, Michael P. ; Chin, Theresa L. ; Ghasabyan, Arsen ; Wohlauer, Max V. ; Barnett, Carlton C. ; Bensard, Denis D. ; Biffl, Walter L. ; Burlew, Clay C. ; Johnson, Jeffrey L. ; Pieracci, Fredric M. ; Jurkovich, Gregory ; Banerjee, Anirban ; Silliman, Christopher C. ; Sauaia, Angela. / Goal-directed hemostatic resuscitation of trauma-induced coagulopathy a pragmatic randomized clinical trial comparing a viscoelastic assay to conventional coagulation assays. In: Annals of Surgery. 2016 ; Vol. 263, No. 6. pp. 1051-1059.
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AU - Gonzalez, Eduardo

AU - Moore, Ernest E.

AU - Moore, Hunter B.

AU - Chapman, Michael P.

AU - Chin, Theresa L.

AU - Ghasabyan, Arsen

AU - Wohlauer, Max V.

AU - Barnett, Carlton C.

AU - Bensard, Denis D.

AU - Biffl, Walter L.

AU - Burlew, Clay C.

AU - Johnson, Jeffrey L.

AU - Pieracci, Fredric M.

AU - Jurkovich, Gregory

AU - Banerjee, Anirban

AU - Silliman, Christopher C.

AU - Sauaia, Angela

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N2 - 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.

AB - 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.

KW - Coagulopathy

KW - Fibrinolysis

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KW - Resuscitation

KW - Thrombelastography

KW - Transfusion

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