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 will take place in all 23 Major Trauma Centres in England, as well as International Sites in North America and Australia.
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