A Trauma Research Study

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.

Kcentra^® (or 4-factor prothrombin complex concentrate) is a Food and Drug Administration (FDA) approved product that contains clotting factors. It is currently used to reverse the effects of medications given to “thin” the blood in patients when they experience bleeding and/or require surgery.

There is evidence that Kcentra may 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 people dying from their injuries because of blood loss.

Participants include patients who have been injured, and who are deemed to require a blood transfusion. We know that such patients are at high risk of dying. The study will take place right here in our community, in patients cared for in our trauma center. The treatment (Kcentra or placebo) will be given as an IV (into a vein) infusion, which lasts about 10 to 15 minutes. The treatment will be given in addition to all usual care.