ITACTIC
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
77.0% male
N = 396
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%
64%
67.0 %
50.3 %
33.5 %
16.8 %
0.0 %
Viscoelastic hemostatic
assays
Conventional coagulation
tests
No significant
difference ↔
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.
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