Trauma and Prothrombin Complex Concentrate (TAP) trial

Trauma is the leading cause of death in those under the age of 45. The most common cause of preventable death after injury is bleeding, which is often accompanied by clotting factor abnormalities. Kcentra® (or 4-factor prothrombin complex concentrate) is a Food and Drug Administration (FDA) approved product that contains clotting factors.

There is evidence that Kcentra may be beneficial (reduce the chance of dying) in injured patients who are not on blood-thinning medication. The TAP trial is a research trial to see whether Kcentra reduces the chances of injured people dying from their injuries. The aim of the Trauma and PCC (TAP) trial is to formally evaluate the effectiveness of Kcentra, in addition to all standard care, in injured patients predicted to require a large volume blood transfusion. Standard care typically involves the transfusion of different types of blood products, and the use of medications to help the blood clot (as well as surgery, to stop the bleeding).

Because Kcentra must be administered quickly to possibly help patients and most patients cannot consent to a study soon after a serious injury, most patients will be enrolled under Exception from Informed Consent regulations (see study links for more information on this).

TAP is one of the largest trauma trials ever conducted. It will involve up to 8,000 patients, across 140 hospitals (around 100 of them in the United States, the remainder in a small number of other countries).