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 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 such patients 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.
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 emergency department.
The treatment (Kcentra® or placebo) will be given as an IV (into a vein) infusion, which lasts about 10-15 minutes. The treatment will be given in addition to all usual care.
What happens afterwards?
There are no other research treatments once the infusion has been completed. We will record patient information and carefully monitor them for any complications.
How can research be done on a person without the person’s permission?
Research is normally only conducted with the express permission of the patient. However, it is often not possible to obtain patients’ consent to study treatments that are administered in life-threatening emergencies. The TAP trial will therefore be conducted under federal regulations that allow for an exception from informed consent (EFIC).
How can a person opt out of this research?
We will provide an “Opt Out of Trauma Research” wristband for those people who do not want to be enrolled in the study. Visit the TAP trial website to learn more about this study and how you can opt out.
Ashley Meagher, MD, MPH, FACS, Principal Investigator
IU School of Medicine and IU Health
1701 North Senate Boulevard, B Floor
Indianapolis, IN 46202
Kimmy Marshall, Clinical Research Nurse