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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 by Nicola Curry; Ross Davenport; Joanne Lucas; Alison Deary; Jonathan Benger; Antoinette Edwards; Amy Evans; Claire Foley; Laura Green; Stephen Morris; Helen Thomas; Karim Brohi; Simon J. Stanworth is a Medicine article available to read on EtoBox.

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## Abstract ## Objectives To describe the protocol for a multinational randomised, parallel, superiority trial, in which patients were randomised to receive early high‐dose cryoprecipitate in addition to standard major haemorrhage protocol (MHP), or Standard MHP alone. ## Background Blood transfusion support for trauma‐related major bleeding includes red cells, plasma and platelets. The role of concentrated sources of fibrinogen is less clear and has not been evaluated in large clinical trials. Fibrinogen is a key pro‐coagulant factor that is essential for stable clot formation. A pilot trial had demonstrated that it was feasible to deliver cryoprecipitate as a source of fibrinogen within 90 min of admission. ## Methods Randomisation was via opaque sealed envelopes held securely in participating Emergency Departments or transfusion laboratories. Early cryoprecipitate, provided as 3 pools (equivalent to 15 single units of cryoprecipitate or 6 g fibrinogen supplementation), was transfused as rapidly as possible, and started within 90 min of admission. Participants in both arms received standard treatment defined in the receiving hospital MHP. The primary outcome measure was all‐cause

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Author

Nicola Curry; Ross Davenport; Joanne Lucas; Alison Deary; Jonathan Benger; Antoinette Edwards; Amy Evans; Claire Foley; Laura Green; Stephen Morris; Helen Thomas; Karim Brohi; Simon J. Stanworth

Publisher

Wiley

Published

2022

Language

EN

Field

Medicine (Health Sciences)