Early cryoprecipitate in major trauma haemorrhage: CRYOSTAT-2
Research type
Research Study
Full title
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
IRAS ID
210735
Contact name
Karim Brohi
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Research Summary
Every year in the UK, trauma (e.g. car accidents, stabbings) kills 12,500 people, with most of those who die under the age of 45. For the same age group that is more than cancer, HIV/AIDS and heart disease combined. One of the most common causes of death in trauma patients is uncontrolled bleeding. At present, standard treatment for severe bleeding involves rapid infusion of red blood cells and blood components e.g. plasma and platelets in large volumes. Until recently one out of every two people who received a massive blood transfusion (more than 10 pints) would die from their injuries.
Two important studies involving bleeding trauma patients have been conducted in the last five years showing that early intervention is more effective after injury and may help save lives. Patients who have severe bleeding after injury develop a problem with their clotting system which means that they tend to bleed more. One of the main problems is due to low levels of fibrinogen, a clotting protein normally circulating in the bloodstream. Fibrinogen acts as the ‘glue’ which holds a blood clot together and at low levels, blood clots don’t form properly and bleeding can continue. Cryoprecipitate is a frozen blood component prepared from plasma and rich in fibrinogen. By transfusing cryoprecipitate early to replace fibrinogen levels in bleeding trauma patients we believe blood clots will be more stable and reduce bleeding.
We propose to undertake a large research study, called a randomised controlled trial where patients are randomly divided into two groups and treatments are compared: A) standard treatment with normal blood transfusions B) early cryoprecipitate + standard treatment with normal blood transfusions, to see if cryoprecipitate can improve survival in trauma patients with severe bleeding.
In UK hospitals, results from a large study across 22 centres show that cryoprecipitate is given on average three hours after injury. We think this is too late and want to give a high dose of cryoprecipitate within 90 minutes of a bleeding trauma patient’s admission to hospital.
This study will determine whether or not giving cryoprecipitate treatment reduces death rates. Trauma patients with severe bleeding who are taken to any Major Trauma Centre across the country will be eligible to enter the trial. The results of this study will have the potential to influence the way doctors and nurses all over the world treat trauma patients. We hope this innovative trial will contribute to the advancement of medicine and save many lives.Summary of Results
Uncontrolled bleeding following injury is a leading cause of death and disability, killing over 12,000 people in the UK every year. People who have severe bleeding after injury often develop a problem with their clotting system which means that they tend to bleed more. One change after trauma is low levels of fibrinogen, a clotting protein normally circulating in the bloodstream. Fibrinogen acts as the ‘glue’ which holds a blood clot together. At low levels, blood clots do not form properly, and bleeding can continue. Cryoprecipitate is stored as a frozen type of blood component which is prepared from plasma after blood donation. It is rich in fibrinogen. This study investigated whether giving a high dose of cryoprecipitate transfusion as soon as possible after injury reduced death rates.
We studied people who required a blood transfusion following major injury due to trauma admitted at 26 hospitals in the UK and USA. 1604 people were allocated at random to two study groups. One group were given an early transfusion of high-dose cryoprecipitate in addition to standard treatments including other blood transfusions. The other received the standard treatment alone.
Outcomes from 1531 participants were analysed. In participants treated with the additional early cryoprecipitate the death rate was 25.3% (192/760). In the standard treatment group, it was 26.1% (201/771). There was no evidence of an effect on death rate of treating patients with early high-dose cryoprecipitate. There were also no differences in side effects. The economic analysis shows that overall, there was no difference in treatment costs and quality of life for those patients receiving early cryoprecipitate.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0164
Date of REC Opinion
26 May 2017
REC opinion
Further Information Favourable Opinion