Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial
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Publisher URL
DOI
10.1007/s00134-020-06266-1
Journal
INTENSIVE CARE MEDICINE
ISSN
0342-4642
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Show full item recordAbstract
Purpose: Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols
(MHPs) to prevent and treat coagulopathy. We aimed to determine whether augmenting MHPs with Viscoelastic Haemostatic
Assays (VHA) would improve outcomes compared to Conventional Coagulation Tests (CCTs).
Methods: This was a multi-centre, randomized controlled trial comparing outcomes in trauma patients who received
empiric MHPs, augmented by either VHA or CCT-guided interventions. Primary outcome was the proportion of subjects
who, at 24 h after injury, were alive and free of massive transfusion (10 or more red cell transfusions). Secondary
outcomes included 28-day mortality. Pre-specified subgroups included patients with severe traumatic brain injury
(TBI).
Results: Of 396 patients in the intention to treat analysis, 201 were allocated to VHA and 195 to CCT-guided therapy.
At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (VHA:
67%, CCT: 64%, OR 1.15, 95% CI 0.76–1.73). 28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84,
95% CI 0.54–1.31), nor were there differences in other secondary outcomes or serious adverse events. In pre-specified
subgroups, there were no differences in primary outcomes. In the pre-specified subgroup of 74 patients with TBI, 64%
were alive and free of massive transfusion at 24 h compared to 46% in the CCT arm (OR 2.12, 95% CI 0.84–5.34).
Conclusion: There was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage
protocols.