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Randomized Controlled Trial
. 2024 Nov 1;141(5):904-912.
doi: 10.1097/ALN.0000000000005183.

Correction of Trauma-induced Coagulopathy by Goal-directed Therapy: A Secondary Analysis of the ITACTIC Trial

Charlotte Lindsay  1 , Ross Davenport  1 , Kjersti Baksaas-Aasen  2 , Knut Magne Kolstadbråten  2 , Pål Aksel Naess  2 , Nicola Curry  3 , Marc Maegele  4 , Nicole Juffermans  5 , Simon Stanworth  3 , Jakob Stensballe  6 , Per Ingemar Johansson  6 , Christine Gaarder  2 , Karim Brohi  2
Affiliations
Randomized Controlled Trial

Correction of Trauma-induced Coagulopathy by Goal-directed Therapy: A Secondary Analysis of the ITACTIC Trial

Charlotte Lindsay et al. Anesthesiology. .

Abstract

Background: Trauma hemorrhage induces a coagulopathy with a high associated mortality rate. The Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy (ITACTIC) randomized trial tested two goal-directed treatment algorithms for coagulation management: one guided by conventional coagulation tests and one by viscoelastic hemostatic assays (viscoelastic). The lack of a difference in 28-day mortality led the authors to hypothesize that coagulopathic patients received insufficient treatment to correct coagulopathy.

Methods: During ITACTIC, two sites were coenrolling patients into an ongoing prospective observational study, which included serial blood sampling at the same intervals as in ITACTIC. The subgroup in both studies had conventional and viscoelastic test results for each patient available for analysis. A goal-directed treatment was defined as one triggered by an ITACTIC algorithm. Coagulopathy was defined as rotational thromboelastometry EXTEM A5 less than 40 mm. The primary outcome was correction of coagulopathy by the 12th unit of erythrocyte transfusion during resuscitation.

Results: Full viscoelastic and conventional coagulation test results were available for 133 patients. Of these patients, 71% were coagulopathic on admission, and 16% developed a coagulopathy during resuscitation. ITACTIC viscoelastic hemostatic assay group patients were more likely to receive goal-directed treatment than the standard group (76% vs. 47%; odds ratio, 3.73; 95% CI, 1.64 to 8.49; P = 0.002). However, only 54% of patients received goal-directed treatment, and only 20% corrected their coagulopathy (vs. 0% with empiric treatment alone; not significant). Median time to first goal-directed treatment was 68 (53 to 88) min for viscoelastic and 110 (77 to 123) min for standard (P = 0.005).

Conclusions: In ITACTIC, many bleeding trauma patients did not receive an indicated goal-directed treatment. Interventions arrived late during resuscitation and were only partially effective at correcting coagulopathy.

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Conflict of interest statement

Dr. Curry has received research grants from CSL Behring (King of Prussia, Pennsylvania) and Sobi (Stockholm, Sweden) and has served on advisory boards for LFB Biomedicaments (Les Ulis, France), Octapharma (Lachen, Swittzerland), and Sobi. Dr. Maegele has received honoraria for lectures and speakers’ bureaus, congress travel support, and financial support for research projects from Astra Zeneca (Cambridge, United Kingdom), Bayer (Leverkusen, Germany), CSL Behring, Werfen (Barcelona, Spain), LFB Biomedicaments, Octapharma, and Portola Inc. (South San Francisco, California). Dr. Johansson has received unrestricted research grants from Haemonetics Corp. (Boston, Massachusetts) and Octapharma. Dr. Gaarder has received honoraria for lectures from Octapharma, has received research grant support from Haemonetics (Boston, Massachusetts) and Werfen in the form of device and reagent support, and also has previously served on the advisory board for Nycomed (Zurich, Switzerland). Dr. Brohi and Dr. Davenport have received research grant support from Werfen and Haemosonics (Boston, Massachusetts) in the form of device and reagent support and have served on external advisory panels for Octapharma, Astra Zeneca, and Werfen. Dr. Brohi has previously served on external advisory panels for Haemonetics Corp, Werfen, CSL Behring, Bayer, and Astra Zeneca. The other authors declare no competing interests.

Figures

Fig. 1.
Fig. 1.
Study flow chart. ACIT, Activation of Coagulation and Inflammation in Trauma; CCT, conventional coagulation test; ITACTIC, Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy; VHA, viscoelastic hemostatic assay.
Fig. 2.
Fig. 2.
Correction of coagulopathy (EXTEM A5 less than 40 mm) by mortality, treatment arm, and goal-directed therapy. Shown are the percentages of patients with admission coagulopathy (EXTEM A5 less than or equal to 40 mm) in whom coagulopathy has resolved by the final sample available for each patient. (A) Survivors versus nonsurvivors. (B) Conventional coagulation test (CCT) versus viscoelastic hemostatic assay (VHA) arm. (C) Goal-directed therapy versus empiric transfusion protocol (all P = not significant).
Fig. 3.
Fig. 3.
Trauma-induced coagulopathy during resuscitation. The box plots show changes in EXTEM A5 (A1–3) and prothrombin time ratio (PTr, B1–3) during hemorrhage and resuscitation. The sampling points are at baseline and after 4, 8, and 12 units of packed erythrocytes (PRBC). Green, survivors versus nonsurvivors; blue, conventional coagulation test (CCT) versus viscoelastic hemostatic assay (VHA) arms; red, targeted treatment versus no targeted treatment. The dotted lines represent the ROTEM and PTr thresholds for trauma-induced coagulopathy (EXTEM A5 less than 40 mm and PTr greater than 1.2). Differences in coagulation parameters between groups during transfusion were analyzed with two-way ANOVA.
Fig. 4.
Fig. 4.
Timing of diagnostic test result availability and administration of goal-directed interventions. The box plots show the time to first actionable result (red boxes) for each test and the time to transfusion of the first targeted treatments for patients with a baseline abnormality in the viscoelastic hemostatic assay (VHA, dark blue) and conventional coagulation test (CCT, light blue) arms. For VHA, any treatment n = 36, fibrinogen n = 28, platelets n = 32; and for CCT, any treatment n = 13; fibrinogen n = 17, platelets n = 2.
None
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Comment in

  • Anesthesiology. 141:10.1097/ALN.0000000000005189.

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