6/28/23, 11:40 PM ITACTIC Pathway Feedback Search Clinical Topics Home Studies ITACTIC ITACTIC Disease Traumatic hemorrhage Trial question What is the role of viscoelastic hemostatic assay augmented protocols for major traumatic hemorrhage? Study design Multi-center Single blinded RCT Population Characteristics of study participants 23.0% female N = 396 77.0% male 396 patients (92 female, 304 male) Inclusion criteria: adult trauma patients presenting with clinical signs of bleeding who received empiric major hemorrhage protocols Key exclusion criteria: no signs of hemorrhagic shock, not randomized within 3 hours of injury or 1 hour of admission to the emergency department Interventions N=201 viscoelastic hemostatic assays (analyses performed at the point of care) N=195 conventional coagulation tests (conventional coagulation tests performed in the laboratory) Primary outcome Patients alive and free of massive transfusion at 24 hours after injury 67 67 0 % 64 https://web.pathway.md/studies/recbeeKct1aNDhVQT 1/2 6/28/23, 11:40 PM 67.0 % ITACTIC Pathway 64 50.3 % 33.5 % 16.8 % No significant difference 0.0 % Viscoelastic hemostatic assays Conventional coagulation tests No significant difference in patients alive and free of massive transfusion at 24 hours after injury (67% vs. 64%; OR 1.15, 95% CI 0.76 to 1.73) Secondary outcomes No significant difference in death at 28 days (25% vs. 28%; OR 0.84, 95% CI 0.54 to 1.31) No significant difference in massive transfusion at 24 hours (26% vs. 28%; OR 0.91, 95% CI 0.59 to 1.42) No significant difference in PT ratio > 1.2 at hemostatis (15% vs. 11%; OR 1.37, 95% CI 0.7 to 2.69) Safety outcomes No significant difference in serious adverse events. Conclusion In adult trauma patients presenting with clinical signs of bleeding who received empiric major hemorrhage protocols, viscoelastic hemostatic assays were not superior to conventional coagulation tests with respect to patients alive and free of massive transfusion at 24 hours after injury. Reference K Baksaas-Aasen, L S Gall, J Stensballe et al. Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial. Intensive Care Med. 2021 Jan;47(1):49-59. Open reference URL https://web.pathway.md/studies/recbeeKct1aNDhVQT 2/2