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

Oslo University Hospital & University of Oslo, Oslo, Norway. Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK. Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. Amsterdam University Medical Centres, Amsterdam, The Netherlands. Oxford University Hospital NHS Trust, Oxford, UK. Cologne-Merheim Medical Centre, University of Witten/Herdecke, Cologne, Germany. Nottingham University Hospitals NHS Trust, Nottingham, UK. Queen Mary University of London, London, UK. NHS Blood and Transplant, Bristol, UK. Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute, 4 Newark Street, London, E1 2AT, UK. k.brohi@qmul.ac.uk.

Intensive care medicine. 2020
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PICO Summary

Population

Trauma patients from the ITACTIC trial (n= 396).

Intervention

Empiric major haemorrhage protocols (MHPs) augmented by Viscoelastic Haemostatic Assays (VHA), (n= 201).

Comparison

Interventions guided by Conventional Coagulation Tests (CCTs), (n= 195).

Outcome

At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (VHA: 67%, CCT: 64%). 28-day mortality was not different overall (VHA: 25%, CCT: 28%), nor were there differences in other secondary outcomes or serious adverse events. In pre-specified subgroups which included patients with severe traumatic brain injury (TBI), 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.
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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine