For investigators

Bleeding accounts for 40% of all deaths from trauma, many within hours of injury. Our recent NIHR Programme Grant for Applied Research found that approximately 7,780 people nationally suffer major haemorrhage each year, of whom an estimated 2,800 will die, at a total cost of nearly £150m to the NHS [Campbell et al, 2015].

Fibrinogen is the key pro-coagulant factor needed for stable clot formation and the earliest clotting protein to fall during active major bleeding [Hiippala et al, 1995]. 25% of all trauma patients have abnormal blood clotting, which causes higher rates of major haemorrhage and four fold increased risk of death. The primary clotting abnormalities in trauma are: increased clot breakdown and low fibrinogen levels.

The CRASH-2 trial has shown that early treatment with tranexamic acid prevents clot breakdown and reduces mortality from trauma haemorrhage [Shakur et al, 2010]. The results of our national observational trauma transfusion study found cryoprecipitate is administered late during the MHP, on average three hours after arrival.

In CRYOSTAT-1 we have shown that early replacement of fibrinogen with cryoprecipitate is able to rapidly restore fibrinogen levels and may halve mortality from trauma haemorrhage [Curry N et al, 2015]. Following on from this work, CRYOSTAT-2 will evaluate whether early administration of high-dose cryoprecipitate, in addition to standard major haemorrhage therapy, improves survival from traumatic bleeding.

The results from this trial will immediately inform transfusion resuscitation practice both nationally and internationally.

Inclusion criteria

Patients are eligible for this trial if:

Exclusion criteria

A patient will not be eligible for this study if he/she fulfils one or more of the following criteria: