Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial

K Baksaas-Aasen, L S Gall, J Stensballe, N P Juffermans, N Curry, M Maegele, A Brooks, C Rourke, S Gillespie, J Murphy, R Maroni, P Vulliamy, H H Henriksen, K Holst Pedersen, K M Kolstadbraaten, M R Wirtz, D J B Kleinveld, N Schäfer, S Chinna, R A DavenportP A Naess, J C Goslings, S Eaglestone, S Stanworth, P I Johansson, C Gaarder, K Brohi*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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.

Original languageEnglish
Pages (from-to)49-59
Number of pages11
JournalIntensive Care Medicine
Volume47
Issue number1
DOIs
Publication statusPublished - Jan 2021
Externally publishedYes

Bibliographical note

Funding:
The study was part of the “Targeted Action for Curing Trauma-Induced Coagu‑
lopathy” (TACTIC) program, funded by the European Commission under the
FP7 framework (Grant No. F3-2013-602771). Both TEM® International GmbH
and Haemonetics® Corporation were collaborating organizations in the TAC‑
TIC program. For this ITACTIC study, they provided the ROTEM Sigma and TEG
6S analyzers and all reagents to the relevant participating institutions. Neither
these organizations nor any of their representatives had any role in the study
design, data collection and analysis, decision to publish, or preparation of the
manuscript

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