CRYOSTAT-2

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Evaluating the effects of early high-dose cryoprecipitate in adult patients with major trauma haemorrhage requiring major haemorrhage protocol (MHP) activation

Aim

This study will evaluate whether early fibrinogen supplementation in the form of cryoprecipitate (equivalent of 6g fibrinogen replacement) during major traumatic haemorrhage will reduce mortality.

Background/method

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, 1 out of every 2 people who received a massive blood transfusion (more than 10 pints) would die from their injuries. 2 important studies involving bleeding trauma patients have been conducted in the last 5 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 blood clots together and at low levels, blood clots don’t form properly, meaning bleeding is continuous. 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 bleeding will be reduced. This is 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 AND 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 showed that cryoprecipitate is given on average 3 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.

Chief/Principal investigator

Chief investigator

Chief investigator

Prof Karim Brohi

Principal investigator

Principal investigator

Mr Ansar Mahmood
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