Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial
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 Coagulatio...
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| Veröffentlicht in: | Intensive care medicine Jg. 47; H. 1; S. 49 - 59 |
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.01.2021
Springer Springer Nature B.V |
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| ISSN: | 0342-4642, 1432-1238, 1432-1238 |
| Online-Zugang: | Volltext |
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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. |
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| AbstractList | 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).
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).
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).
There was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols. 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).PURPOSEContemporary 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).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).METHODSThis 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).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).RESULTSOf 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).There was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols.CONCLUSIONThere was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols. 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. 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. PurposeContemporary 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).MethodsThis 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).ResultsOf 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).ConclusionThere was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols. 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). 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). 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). There was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols. |
| Audience | Academic |
| Author | Stensballe, J. Maegele, M. Davenport, R. A. Rourke, C. Goslings, J. C. Maroni, R. Wirtz, M. R. Kolstadbraaten, K. M. Vulliamy, P. Gillespie, S. Johansson, P. I. Naess, P. A. Gall, L. S. Gaarder, C. Kleinveld, D. J. B. Chinna, S. Curry, N. Brohi, K. Stanworth, S. Brooks, A. Baksaas-Aasen, K. Schäfer, N. Juffermans, N. P. Pedersen, K. Holst Henriksen, H. H. Murphy, J. Eaglestone, S. |
| Author_xml | – sequence: 1 givenname: K. surname: Baksaas-Aasen fullname: Baksaas-Aasen, K. organization: Oslo University Hospital & University of Oslo – sequence: 2 givenname: L. S. surname: Gall fullname: Gall, L. S. organization: Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute – sequence: 3 givenname: J. surname: Stensballe fullname: Stensballe, J. organization: Copenhagen University Hospital, Rigshospitalet – sequence: 4 givenname: N. P. surname: Juffermans fullname: Juffermans, N. P. organization: Amsterdam University Medical Centres – sequence: 5 givenname: N. surname: Curry fullname: Curry, N. organization: Oxford University Hospital NHS Trust – sequence: 6 givenname: M. surname: Maegele fullname: Maegele, M. organization: Cologne-Merheim Medical Centre, University of Witten/Herdecke – sequence: 7 givenname: A. surname: Brooks fullname: Brooks, A. organization: Nottingham University Hospitals NHS Trust – sequence: 8 givenname: C. surname: Rourke fullname: Rourke, C. organization: Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute – sequence: 9 givenname: S. surname: Gillespie fullname: Gillespie, S. organization: Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute – sequence: 10 givenname: J. surname: Murphy fullname: Murphy, J. organization: Queen Mary University of London – sequence: 11 givenname: R. surname: Maroni fullname: Maroni, R. organization: Queen Mary University of London – sequence: 12 givenname: P. surname: Vulliamy fullname: Vulliamy, P. organization: Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute – sequence: 13 givenname: H. H. surname: Henriksen fullname: Henriksen, H. H. organization: Copenhagen University Hospital, Rigshospitalet – sequence: 14 givenname: K. Holst surname: Pedersen fullname: Pedersen, K. Holst organization: Copenhagen University Hospital, Rigshospitalet – sequence: 15 givenname: K. M. surname: Kolstadbraaten fullname: Kolstadbraaten, K. M. organization: Oslo University Hospital & University of Oslo – sequence: 16 givenname: M. R. surname: Wirtz fullname: Wirtz, M. R. organization: Amsterdam University Medical Centres – sequence: 17 givenname: D. J. B. surname: Kleinveld fullname: Kleinveld, D. J. B. organization: Amsterdam University Medical Centres – sequence: 18 givenname: N. surname: Schäfer fullname: Schäfer, N. organization: Cologne-Merheim Medical Centre, University of Witten/Herdecke – sequence: 19 givenname: S. surname: Chinna fullname: Chinna, S. organization: Nottingham University Hospitals NHS Trust – sequence: 20 givenname: R. A. surname: Davenport fullname: Davenport, R. A. organization: Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute – sequence: 21 givenname: P. A. surname: Naess fullname: Naess, P. A. organization: Oslo University Hospital & University of Oslo – sequence: 22 givenname: J. C. surname: Goslings fullname: Goslings, J. C. organization: Amsterdam University Medical Centres – sequence: 23 givenname: S. surname: Eaglestone fullname: Eaglestone, S. organization: Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute – sequence: 24 givenname: S. surname: Stanworth fullname: Stanworth, S. organization: Oxford University Hospital NHS Trust, NHS Blood and Transplant – sequence: 25 givenname: P. I. surname: Johansson fullname: Johansson, P. I. organization: Copenhagen University Hospital, Rigshospitalet – sequence: 26 givenname: C. surname: Gaarder fullname: Gaarder, C. organization: Oslo University Hospital & University of Oslo – sequence: 27 givenname: K. surname: Brohi fullname: Brohi, K. email: k.brohi@qmul.ac.uk organization: Centre for Trauma Sciences, Queen Mary University of London, Blizard Institute |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33048195$$D View this record in MEDLINE/PubMed |
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| Keywords | Thromboelastometry Thrombelastography Haemorrhage Trauma Coagulopathy |
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Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We... Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We aimed to... Purpose Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We... PurposeContemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We... |
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| SubjectTerms | Anesthesiology Bleeding Blood Blood Coagulation Disorders Brain Coagulation Comparative analysis Critical Care Medicine Emergency Medicine Head injuries Hemorrhage Hemorrhage - etiology Hemorrhage - therapy Hemostasis Hemostatics Humans Injuries Intensive Intensive care Medical equipment and supplies industry Medical examination Medical test kit industry Medicine Medicine & Public Health Mortality Multicenter Studies as Topic Original Pain Medicine Pediatrics Pneumology/Respiratory System Resuscitation Subgroups Thrombelastography Tranexamic acid Transfusion Trauma Traumatic brain injury United Kingdom United States Viscoelasticity Wounds and Injuries - complications Wounds and Injuries - therapy |
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| Title | Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial |
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