CORRECTION OF TRAUMA-INDUCED COAGULOPATHY BY GOAL DIRECTED THERAPY: A SECONDARY ANALYSIS OF THE ITACTIC TRIAL.

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 us to hypothesize that coagulopathic patients received insufficient treatment to correct coagulopathy.

METHODS: During ITACTIC, two sites were co-enrolling 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 ROTEM EXTEM A5 <40mm. The primary outcome was correction of coagulopathy by the 12th unit of red blood cell transfusion during resuscitation.

RESULTS: Full viscoelastic and conventional coagulation test results were available for 133 patients. 71% were coagulopathic on admission, and 16% developed a coagulopathy during resuscitation. ITACTIC VHA group patients were more likely to receive goal-directed treatment than the standard group (76% vs 47%, OR 3.73, 95%CI:1.64-8.49, 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(53-88) minutes for viscoelastic and 110(77-123) minutes for standard, p=0.005.

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