CRYOSTAT-2

Early cryoprecipitate in trauma

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.

Study contacts

Jo Lucas (Trial Manager)
Tel: 01223 588720

Amy Evans (Trial Coordinator)
Tel: 01223 588016

Email: cryostat2@nhsbt.nhs.uk

Study website

Visit the CRYOSTAT-2 website

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