Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial
Research output: Contribution to journal › Journal article › Research › peer-review
Documents
- Baksaas-Aasen2021_Article_ViscoelasticHaemostaticAssayAu
Final published version, 1.13 MB, PDF document
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 language | English |
|---|---|
| Journal | Intensive Care Medicine |
| Volume | 47 |
| Issue number | 1 |
| Pages (from-to) | 49-59 |
| Number of pages | 11 |
| ISSN | 0342-4642 |
| DOIs | |
| Publication status | Published - Jan 2021 |
Bibliographical note
Funding Information:
The study was part of the “Targeted Action for Curing Trauma-Induced Coagulopathy” (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 TACTIC 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. Acknowledgements
Funding Information:
We would like to thank all the patients and their families who participated in this project. We are grateful for the contributions to the study of the Trial Steering Committee: Beverley Hunt (Chair), Heidi Doughty, Louis Riddez, Leo Geeraedts, Alison Rogers; and the Data Monitoring Committee: Ravi Gill (Chair), Jan Jansen and Phil Edwards. We would also like to acknowledge Joao Dias and Jan Hartmann (Haemonetics? Corporation) and Klaus G?rlinger (TEM International GmbH) for their personal support for the entire TACTIC program. We also acknowledge Amar Ahmed for early statistical support to the trial. This study is funded by the European Commission under the FP-7 HEALTH-Contract No. F3-2013-602771, entitled "Targeted Action for Curing Trauma Induced Coagulopathy" (TACTIC). Website European Commission FP-7 HEALTH-Contract No. F3-2013-602771: https://cordis.europa.eu/project/rcn/110071_en.html.
Funding Information:
K.Baksaas-Aasen, L.S.Gall, J.Stensballe, N.P.Juffermans, N.Curry, 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, P.A.Naess, J.C.Goslings, S.Eaglestone and S.Stanworth declare no conflicts of interest. M.Maegele has received honoraria for lectures and speakers’ bureaus, congress travel support as well as financial support for research projects from Astra Zeneca, Bayer, CSL Behring, IL-Werfen/TEM International, LFB Biomedicaments and Portola Inc. A. Brooks has received a research grant from Haemonetics Corp. in the form of cartridges and reagent support. He has also served on advisory panel for Haemonetics Corp. and TEM International and received honoraria for education lectures for Johnson and Johnson. P.I. Johansson´s has received unrestricted research grants from Haemonetics Corp. and Octapharma AG. C.Gaarder has received honoraria for lectures from Octapharma and research grant support from Haemonetics and TEM International in the form of device and reagent support. She has also previously served on the advisory board for Nycomed. K.Brohi and R.Davenport have received research grant support from TEM International in the form of device and reagent support. K.Brohi has previously served on external advisory panels for Haemonetics Corp, TEM International, CSL Behring, Bayer and Astra Zeneca.
Publisher Copyright:
© 2020, The Author(s).
- Coagulopathy, Haemorrhage, Thrombelastography, Thromboelastometry, Trauma
Research areas
ID: 284196906