Grant: Project Grant

When a patient is severely injured (e.g., high speed car crash, or a pedestrian struck by a car) the most common cause of death is uncontrollable bleeding. The bleeding results from both injury to major blood vessels and from loss of clotting factors in the blood. The best treatment to restore the clotting factors is not known. For the last 70 years, plasma (the liquid part of blood) has been the most common treatment used. In the last 10 years, plasma has been replaced with manufactured clotting factor concentrates at some hospitals. This new clotting factor treatment has only been compared to plasma in small studies but appear to reduce the amount of blood transfused and helps to avoid a "massive transfusion" (getting more than 10 units of blood). The clotting factor treatment has other potential benefits: the products are treated to prevent blood pathogen infections (viruses), less fluid is infused (faster treatment, less fluid overload), and the product does not require thawing or a blood group (faster treatment). On the other side, the clotting factor concentrates are more expensive and the studies done so far cannot determine which of the two treatments are safer. This FiiRST-2 trial will compare these two treatments in 450 severely injured patients at 11 hospitals in Canada. In a computer-randomized fashion, half the patients will get plasma and half will get clotting factors for the first two "blood packs". A standard "blood pack" for a trauma patient contains 4 units of red blood cells and 4 units of plasma. After two blood packs, all patients will switch to the standard plasma blood packs - this is because the safety of giving more than 2 doses of clotting factors has never been tested. If the clotting factor concentrates reduce the amount of blood transfused, do not result in more adverse reactions, and improve patient outcomes, the new strategy would be a major advance in trauma care.