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Randomized Controlled Trial
. 2021 Jan;47(1):49-59.
doi: 10.1007/s00134-020-06266-1. Epub 2020 Oct 13.

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

K Baksaas-Aasen  1 , L S Gall  2 , J Stensballe  3 , N P Juffermans  4 , N Curry  5 , M Maegele  6 , A Brooks  7 , C Rourke  2 , S Gillespie  2 , J Murphy  8 , R Maroni  8 , P Vulliamy  2 , H H Henriksen  3 , K Holst Pedersen  3 , K M Kolstadbraaten  1 , M R Wirtz  4 , D J B Kleinveld  4 , N Schäfer  6 , S Chinna  7 , R A Davenport  2 , P A Naess  1 , J C Goslings  4 , S Eaglestone  2 , S Stanworth  5   9 , P I Johansson  3 , C Gaarder  1 , K Brohi  10
Affiliations
Randomized Controlled Trial

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

K Baksaas-Aasen et al. Intensive Care Med. 2021 Jan.

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.

Keywords: Coagulopathy; Haemorrhage; Thrombelastography; Thromboelastometry; Trauma.

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Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
CONSORT diagram. CCT conventional coagulation test, VHA Viscoelastic Haemostatic Assay, TBI traumatic brain injury
Fig. 2
Fig. 2
Primary outcome (alive and free of massive transfusion at 24 h) in pre-specified subgroups. Odds ratios for the primary outcome (alive and free of massive transfusion at 24 h) in the subgroups of coagulopathic patients at baseline (defined as PTr > 1.2), patients with severe TBI, patients with prior oral anticoagulants, the Per Protocol and Intention-To-Treat (Overall) populations. Odds ratios were calculated using the VHA arm as the exposed group. The solid black line indicates an odds ratio of 1, equivalent to no difference between study groups. The vertical red dashed line indicates the overall odds ratio for the ITT population. Subgroup allocation criteria were missing for some patients, so some subgroups do not add up to 396 patients. In particular, the following patients had missing data in their records: 40 did not have a PTr value at baseline, 9 did not have a TBI score, 6 did not have a record for prior oral anticoagulants. Post-hoc analysis: the p-values for the interaction between study arm and each subgroup were calculated using a logistic regression with “being alive and free of massive transfusion at 24 h” as the outcome. CI confidence interval, CCT conventional coagulation test, VHA viscoelastic haemostatic assay, PTr prothrombin time ratio, TBI traumatic brain injury, ITT intention-to-treat
Fig. 3
Fig. 3
Survival curves at 24 h and 90 days. Survival curves with 95% confidence intervals at 24 h and 90 days for the Intention-To-Treat (ITT) population. Blue: CCT-guided and Red: VHA-guided. The p values shown are the result of the log-rank test. 4 patients in the ITT population had missing date/time of events and were therefore not included in the survival curve. CCT conventional coagulation test, VHA viscoelastic haemostatic assay
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Comment in

References

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