Welcome to the research webpage for the Department of Emergency Medicine at Brown University/ Brown Emergency Medicine! Our department is a national leader in emergency medicine research, and we aim to generate and translate knowledge that will improve the lives of our patients and communities. Our faculty and residents conduct research across a wide range of topics including injury prevention, global health, health equity and population health, acute cerebrovascular disease, sex and gender medicine, trauma, sepsis, substance use and harm reduction, point of care ultrasound, and degenerative joint disease, among others. We have a robust infrastructure to support clinical research in our department, and we collaborate with investigators across departments and other institutions, locally, regionally, and nationally. Please feel free to reach out to Tracy_Madsen@brown.edu with any inquiries about our research program and thank you for your interest. 

Sincerely, 

Tracy Madsen, MD, PhD

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. 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 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 without their consent.

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).

Our department is a site for TAP and will be enrolling patients using an EFIC (exception from informed consent) protocol (see more info at the link below). Site PI is Dr Stephanie Lueckel with Dr. Greg Jay and Dr Selim Suner as Co-Investigators.

TAP Study

RIH, a site for PECARN, a national multi-site clinical trials network, is currently enrolling for PROMPT-Bolus, an EFIC study. The objectives of this multicenter Phase 3 pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% normal saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury. Site PI is Dr. Susan Duffy.

Visit the Lifespan website for more details about this study.

PECARN Prompt Bolus Study