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CRYOSTAT-2

Title
CRYOSTAT-2
CRYOSTAT-2
Study Type
CRYOSTAT-2
Randomised controlled trial
Chief Investigator(s)
CRYOSTAT-2
Professor Karim Brohi and Dr Simon Stanworth
Primary Sponsor
CRYOSTAT-2
The Queen Mary University of London (QMUL)
Funder
CRYOSTAT-2
NIHR Health Technology Assessment Board. Grant number: 15/57/02
NHSBT Research Theme
Summary
CRYOSTAT-2
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
CRYOSTAT-2
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
CRYOSTAT-2
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
CRYOSTAT-2

Dr. Kiri Jefferies-Sewell (Trial Manager)

Tel: 01223 588016

Jo Lucas (Trial Coordinator)

Tel: 01223 588720

Email: cryostat2@nhsbt.nhs.uk

Website: http://cryostat2.co.uk/

Twitter: @CRYOSTAT_2