Randomized clinical trials

Davenport R, Curry N, Fox EE, Thomas H, Lucas J, Evans A et all, for the CRYOSTAT-2 Principal Investigators.

This multicentre study included 1604 seriously injured patients with bleeding. Treatment with cryoprecipitate did not reduce the 30-day mortality rate: 25.3 per cent versus 26.1 per cent in controls (odds ratio 0.96, 95 per cent confidence interval 0.75 to 1.23, P=0.74).

Comment: Disappointing result.

Jansen O, Hudson J, Cochran C, MacLennan G, Lendrum R, Sadek S et al, and the UK-REBOA Study Group

JAMA 2023; 330: 1862-1871.

A total of 90 patients were included. After 90 days, the overall mortality rate was higher after use of the REBOA than standard care: 54 versus 42 per cent (odds ratio 1.58, 95 per cent confidence interval 0.72 to 3.52).

Comment: Disappointing, and deserves more explanation and discussion.

Gyedu A, Stewart BT, Nakua E, Donkor P.

Br J Surg 2023; 110: 1473-1481.

Eight non-tertiary hospitals in Ghana used an adapted WHO Trauma Care Checklist. Documentation of the trauma injury improved in hospitals where the checklist was used after training, as did mortality in 302 patients with severe trauma, from 17.1 to 12.1 per cent, P=0.009.

Comment; Another great example of how a structured approach brings tangible benefits.

The PATCH-Trauma Investigators and the ANZICS Clinical Trials Group.

N Engl J Med 2023; 389: 127-136.

This multicentre study included 1310 injured patients randomly allocated tranexamic acid. After six months, rates of survival with favourable functional outcome were similar: 53.7 per cent with tranexamic acid compared to 53.5 per cent in controls, P=0.95.

Comment: Much of the literature about tranexamic acid is positive, and this requires further analysis and explanation.

Bouzat P, Charbit J, Abback P-S, Huet-Garrigue D, Delhaye N, Leone M et al, for the PROCOAG Study Group.

JAMA 2023; 329: 1367-1375.

In this study of 327 injured patients, use of the prothrombin complex did not reduce the need for blood transfusion within the first 24 hours: 12 versus 11 units, P=0.72. It did increase the risk of thrombotic events by around 11% , P=0.03

Comment: Disappointing results.

Dehghan M, Nauth A, Schemitsch E, Vicente M, Jenkinson R, Kreder H et al, for the Canadian Orthopaedic Trauma Society and the Unstable Chest Wall RCT Study Investigators.

JAMA Surg 2022; 157: 983-990.

The study included 207 patients followed for up to 30 days. Ventilator-free days were higher in the operated group (22.7 versus 20.6; mean difference 2.1 days, P=0.09), and mortality was lower (0 versus 6, P=0.01). The advantage was mainly seen in patients ventilated at time of randomization. Complications rates and length of stay were similar.

Comment: Good study, but relatively modest benefit seen from surgery.