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C4TS awarded £2.4 million for landmark international transfusion trial in major traumatic bleeding

February 8, 2017

C4TS and NHS Blood & Transplant have been awarded £2.4m from the National Institute for Health Research Health and Barts Charity to carry out a large multi-centre Randomised Controlled Trial (RCT) to evaluate early cryoprecipitate in major traumatic haemorrhage (CRYOSTAT-2).

The trial will test the effect of early cryoprecipitate (within 90 minutes of admission) compared to standard blood transfusion therapy, on 1544 severely bleeding trauma patients at all Major Trauma Centres (MTCs) across England and selected international partners in North America and Australia. Patient recruitment will commence in July 2017 and the trial will run for 36 months.  The study will provide the answer as to whether early cryoprecipitate transfused for major traumatic bleeding saves lives.

Cryoprecipitate is a concentrated source of fibrinogen and is already used as a treatment for patients with major bleeding. However transfusion typically occurs late (3 hours or more) after arrival in the Emergency Department.

In 2013, C4TS working with NHS Blood & Transplant undertook CRYOSTAT-1, a small study that found it was feasible to deliver cryoprecipitate to trauma patients within an hour of admission, and this appeared to reduce mortality.

Explaining the importance of the study, Principal Investigator Dr Ross Davenport said:

"Major haemorrhage is the most common preventable cause of death in the trauma population, with most deaths occurring within the first 6 hours after injury.  As many as 4 in every 10 patients affected by severe trauma die from uncontrolled bleeding."

"C4TS research to date has shown that low fibrinogen levels on admission to hospital are predictors of early mortality in trauma patients.  Fibrinogen is a blood protein essential for forming clots and replacing it early with specific fibrinogen-rich blood transfusions may save lives. This RCT will help us determine if administering cryoprecipitate within 90 minutes of admission will save the lives of more severely bleeding trauma patients."

"This will be the first national transfusion study in the UK since trauma networks were established in England and Wales. Improved transfusion practices have the potential to save millions of lives globally."

The RCT will be recruiting first patients from July 2017, if not before.

For more information, please contact Dr Ross Davenport

More background on the study can be found here

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