Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial.
Current approaches to trauma resuscitation focus on the timely control of bleeding and correction of trauma-induced coagulopathy using the administration of haemostatic therapy. Over the past decade, targeted and individualized strategies to identify and correct coagulopathy have been implemented. Conventional coagulation tests have been incorporated into standardized transfusion algorithms but suffer from slow turn-around times. Viscoelastic hemostatic assays have been increasingly used in trauma patients as they can be used as point-of-care at the bedside. However, evidence from robust multi-centre randomized trials on the efficacy of viscoelastic tests to guide haemostatic therapy is lacking in trauma.
The present study is a multi-centre randomized controlled trial comparing outcomes in trauma patients who were treated based on either viscoelastic haemostatic assays or conventional coagulation tests‐guided interventions. The primary outcome was the proportion of subjects who were alive and free of massive transfusion (10 or more red cell transfusions) at 24 hours after injury. Secondary outcomes included 28‐day mortality. Of the 396 patients included in the intention-to-treat analysis, 201 were allocated to viscoelastic haemostatic assays and 195 to conventional coagulation tests‐guided therapy. At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (67% vs. 64%, odds ratio 1.15; 95% CI 0.76–1.73). 28‐day mortality was not different overall, nor were there differences in other secondary outcomes or serious adverse events.
Although the results are somewhat disappointing, a few important messages can be drawn. Strategies to treat trauma-induced coagulopathy have significantly evolved over the last decade, and the use of standard transfusion algorithms based on the assessment of coagulation are now standard of care. The absence of difference could be explained by the relatively small number of patients randomized, as well as by the fact that, in the context of the study, the timing to obtain the results from viscoelastic tests or conventional tests might have been optimised. Also, one could argue that the degree of coagulopathy observed in that study was less important that one could have expected.
In conclusion, standardised transfusion protocol with either viscoelastic or conventional tests should be used to optimize management of traumatized patients. Viscoelastic tests might be preferred if the results from conventional tests cannot be obtained within a reasonable delay.
– David Faraoni