Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled tria
- PDF / 1,198,992 Bytes
- 11 Pages / 595.276 x 790.866 pts Page_size
- 85 Downloads / 164 Views
ORIGINAL
Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial K. Baksaas‑Aasen1, L. S. Gall2, J. Stensballe3, N. P. Juffermans4, N. Curry5, M. Maegele6, A. Brooks7, C. Rourke2, S. Gillespie2, J. Murphy8, R. Maroni8, P. Vulliamy2, H. H. Henriksen3, K. Holst Pedersen3, K. M. Kolstadbraaten1, M. R. Wirtz4, D. J. B. Kleinveld4, N. Schäfer6, S. Chinna7, R. A. Davenport2, P. A. Naess1, J. C. Goslings4, S. Eaglestone2, S. Stanworth5,9, P. I. Johansson3, C. Gaarder1 and K. Brohi2* © 2020 The Author(s)
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 Hae‑ mostatic 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 sub‑ jects 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. Keywords: Trauma, Haemorrhage, Coagulopathy, Thrombelastography, Thromboelastometry
*Correspondence: [email protected] 2 Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London E1 2AT, UK Full author information is available at the end of the article
Introduction Major haemorrhage after trauma is estimated to be responsible for nearly half of the annual 4.6 million injury deaths worldwide [1]. Up to 50% of critically bleeding patients will die, either early from exsanguination, or later from multiple organ dysfunction or associated traumatic brain injury [2, 3]. Current approaches to trauma resuscitation focus on control of bleeding and management of traumainduced coagulopathy with the timely administration of haemostatic therapy [2, 4]. In the initial phases of care, these therapies are often delivered empirically as part of
Data Loading...
