Early high-dose cryoprecipitate to reduce mortality in adult patients with traumatic haemorrhage: the CRYOSTAT-2 RCT with cost-effectiveness analysis

作者：Nicola Curry, Ross Davenport, Helen Thomas, Erin E. Fox, Joanne Lucas, Amy Evans, Efthalia Massou, Rupa Sharma, Shaminie Shanmugaranjan, Claire Rourke, Alice Newton, Alison Deary, Nikki Dallas, Chloe Fitzpatrick-Creamer, Jeanette M. Podbielski, Charles E. Wade, Antoinette Edwards, Jonathan Benger, Stephen Morris, Bryan A. Cotton, James Piercy, Laura Green, Karim Brohi, Simon Stanworth · 发表于：Health Technology Assessment · 年份：2024 · DOI：10.3310/jytr6938 · 被引用次数：7 · 研究领域：Trauma, Hemostasis, Coagulopathy, Resuscitation、Abdominal Trauma and Injuries、Hemostasis and retained surgical items

Background Traumatic haemorrhage is common after severe injury, leading to disability and death. Cryoprecipitate, a source of fibrinogen, may improve outcomes for patients with traumatic haemorrhage. Objective To investigate the effects of early fibrinogen supplementation in the form of 3 pools (15 units, approximately 6 g of fibrinogen) of cryoprecipitate on 28-day mortality. Design A randomised, parallel-group, unblinded, multicentre, international trial and economic evaluation. Patients were randomised to either the intervention (early cryoprecipitate) or the comparator (standard major haemorrhage protocol) arm via opaque, sealed envelopes in the emergency department or the transfusion laboratory/blood bank. All analyses were performed on an intention-to-treat basis. A cost-effectiveness analysis was undertaken. Setting Twenty-five major trauma centres in the UK and one level 1 trauma centre in the USA. Participants Adults who had traumatic haemorrhage following severe injury requiring activation of the major haemorrhage protocol and had received a blood transfusion. Intervention Early cryoprecipitate – 3 pools (equivalent to 15 single units of cryoprecipitate or 6 g of fibrinogen supplementation), infused as rapidly as possible, within 90 minutes of arrival at hospital in addition to standard major haemorrhage protocol or standard major haemorrhage protocol only. Main outcome measures The primary outcome was all-cause mortality at 28 days. The secondary outcomes were all-...