CRYOSTAT-2

Early cryoprecipitate in trauma

The CRYOSTAT-2 study is now complete.

Chief investigators: Professor Karim Brohi and Professor Simon Stanworth
Primary sponsor: The Queen Mary University of London (QMUL)
Funder: NIHR Health Technology Assessment Board. Grant number: 15/57/02

Summary

A multi-centre, randomised, controlled trial evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol (MHP) activation.

Study hypothesis

Major bleeding after injury is exacerbated by a clotting abnormality – ‘acute traumatic coagulopathy’ (ATC). ATC is characterised by hypofibrinogenaemia and fibrinolysis. Early replacement of fibrinogen will treat the coagulopathy and may reduce bleeding and improve outcomes. This study will evaluate whether early fibrinogen supplementation in the form of cryoprecipitate (equivalent of 6g fibrinogen replacement) during major traumatic haemorrhage will reduce mortality at 28 days. Secondary outcomes include all-cause mortality up to 12 months, death from bleeding, symbiotic thrombotic events, total transfusion requirements, hospital resource use and quality of life measures.

Study design

Interventional phase III study. Multi-centre, interventional, randomised, unblinded, parallel controlled trial. Participants will be randomised 1:1 via opaque sealed envelopes held securely in participating sites. The study took place in 26 Major Trauma Centres in the UK and US.

Study results

The full results can be found in the published JAMA paper (link available in the publications section below). A summary of the results can be found here. 

Study contacts

cryostat2@nhsbt.nhs.uk

Publications

M. Marsden, J. Benger, K. Brohi, N. Curry, C. Foley, L. Green, J. Lucas, A. Rossetto, S. Stanworth, H. Thomas, R. Davenport, on behalf of the CRYOSTAT-2 investigators. Coagulopathy, cryoprecipitate and CRYOSTAT-2: realising the potential of a nationwide trauma system for a national clinical trial. British Journal of Anaesthesia: 1e5 (2018) DOI: https://doi.org/10.1016/j.bja.2018.10.055
View publication on the British Journal of Anaesthesia website

Curry N, Davenport R, Lucas J, et al. The CRYOSTAT2 trial: The rationale and study protocol for a multi-Centre, randomised, controlled trial evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol activation. Transfusion Medicine. 2023; 33(2): 123-131. doi:10.1111/tme.12932
View publication on the Transfusion Medicine website

Davenport R, Curry N, Fox EE, et al. Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023;330(19):1882–1891. doi:10.1001/jama.2023.21019
View publication on the JAMA website