Division of Clinical Research

Clinical Research at UNC Emergency Medicine

The Division of Clinical Research in the UNC Department of Emergency Medicine is dedicated to improving emergency care through industry-sponsored and investigator-sponsored trials of drugs, devices, biologics.  The program, created in 2008, has established itself as a reliable and high-enrolling site for emergency care trials.  Over the last six years, the Division has specialized in trials focusing on ED interventions that reduce mortality and improve outcomes.  The broad scope of emergency care is reflected in the domains of research within the Division.

 We also serve as a resource to faculty interested in pursuing all levels of engaging interventional clinical research.  Collaborations with other hospital departments extend our reach into the robust, over-arching community of clinical research at UNC. 

 Contracts, grants, and awards for the past two years total more than $1.5 million.  The Division supports four full-time employees and allows for 16-hour coverage of the ED.  Just steps away from the ED, a dedicated office and laboratory space houses a -80 F freezer, centrifuge, chemical hood, and all resources necessary for aliquoting and preparing specimens. 

 The goals for future growth are three-fold:

 

  1. Enhance support for basic, clinical, and health services research pertinent to emergency medicine practice.
  2. Seek and develop increased funding sources for emergency medicine research.
  3. Promote faculty engagement within the Department and nurture interdisciplinary research within and across traditional institutional boundaries.

 Thank you for your interest in our research activities, and please don’t hesitate to contact us with any inquiries

Assistant Professor of Emergency Medicine

Eugenia Quackenbush, MD, FACEP
Assistant Professor of Emergency Medicine
Director of the UNC Department of Emergency Medicine, Division of Clinical Research

Staff:

 

Eugenia Quackenbush, MD, FACEP
Director


Clinical Research Specialist

*for questions about any current study, please contact Gait Jordan.


Clinical Research Assistant


Clinical Research Assistant


Clinical Research Assistant


Current Studies*:

 A Randomized, Double-Blind, Placebo-Controlled Study Comparing CroFab® Versus Placebo With Rescue Treatment for Copperhead Snake Envenomation (Copperhead RCT)

 PI: Eugenia Quackenbush, MD         

Sponsor:  BTG International Inc.                              

 This study will evaluate the recovery from copperhead snake bite in patients with mild or moderate venom effect. Potential subjects will receive CroFab antivenom or placebo. The trial is conducted by emergency room doctors, toxicologists, or surgeons at hospitals in regions where copperhead bites are common. After blinded treatment and discharge, the subject returns to the clinic for follow-up assessments at day 3, 7, 14, and 28 after snake bite. The subject will also be called by telephone for follow-up assessments on day 10, 17, and 24 after snake bite. The purpose of this study is to compare recovery in copperhead snake bite patients treated with antivenom versus placebo (no active drug) as measured by the Patient Specific Functional Scale (PSFS) at Day 14 follow-up.

 

Safety and Efficacy of Investigational Anti-Influenza Immune Plasma in Treating Influenza (IRC002)

 PI:  Charles Cairns, MD

Sponsor:  National Institute of Allergy and Infectious Disease (NIAID)

 This randomized, open-label, multicenter phase 2 trial will assess the safety, efficacy, and pharmacokinetics (PK) of anti-influenza plasma in subjects with influenza A or B. Hospitalized subjects with influenza A or B that have either a low oxygen level or a high respiratory rate will be eligible for study participation.

 

Study of an Emergency Department-based Intervention to Reduce Alcohol Misuse in Older Adults

 PI:  Christina Shenvi, MD

Sponsor:  National Institute on Aging (NIA)

 This is a randomized trial to assess the value of an emergency department-based intervention to reduce hazardous alcohol use among older adults. We hypothesize that the intervention will result in a 25% reduction in the prevalence of hazardous alcohol use while the control group will only have a 5% reduction.

 

Clinical Performance of Elecsys Troponin T Gen 5 in Subjects with Symptoms of Acute Coronary Syndrome (ACS): ACS Collection Study for Serum Claim

 PI: Abhi Mehrotra, MD

Sponsor:  Roche Diagnostics Operations, Inc.

This Multicenter sample collection study is designed to obtain samples from subjects with symptoms suggestive of Acute Coronary Syndrome (ACS) at approximately 10 or more collection sites within the U.S.  A minimum of 400 subjects who meet the inclusion criteria will be required for this ACS enrollment for the purpose of demonstrating equivalency between serum and Li Heparin plasma. A thirty day and 12 month follow up of the subjects by phone and chart review will also be performed.  An additional 920 subjects totaling 1320 will be obtained for future TnT Gen 5 testing on additional cobas analyzers.  All subject diagnosis will be adjudicated by an independent Clinical Events Committee.

The concentration of troponin in prospectively collected specimens from subjects presenting to the Emergency Department (ED) with symptoms suggestive of ACS will be measured using the Roche Elecsys Troponin T Gen 5 assay at three (3) external US sites on both the cobas e411 and e601 immunoassay analyzers. All samples will be included for testing for future claims on Roche cobas analyzers on both serum and plasma.

 

UNC Emergency Department Research Bio-Repository

 PI:  Eugenia Quackenbush, MD

Sponsor:  UNC Department of Emergency Medicine

 The purpose of this project is to collect and store clinical data, blood, and/or urine for future research on patients who present to the Emergency Department at the University of North Carolina (UNC) at Chapel Hill.   Additional samples collected in the course of routine care (e.g.sputum, cerebral spinal fluid) would also be obtained and stored.  We have unique access to patients of all ages who are presenting to us for various complaints.  Researchers have a need for access to such samples; there is value in obtaining and storing such samples for future research, including but not limited to studies of infection, acute coronary syndromes, aging, metabolomics, proteomics, coagulopathy in trauma

 

Treprostinil Sodium Inhalation for Early ARDS and At-Risk Patients: Effect on Oxygenation and Disease-Related Biomarkers

 PI:  Jimmy Ford, MD

Co-Is:  Shannon Carson, MD; Charles Cairns, MD; Wayne Anderson, Ph.D.; Eugenia Quackenbush, MD

Purpose: The purpose of this research study is to assess the effect of treprostinil inhalation on oxygenation in patients with hypoxic respiratory failure with, or at risk for, development of acute lung injury (ALI) also known as adult respiratory distress syndrome (ARDS).  ALI is a syndrome of inflammation and increased permeability that may coexist with left atrial or pulmonary capillary hypertension.This study will also assess the effect of treprostinil inhalation on various biomarkers thought to be related to the pathogenesis and/or clinical course of ARDS.

Participants will be patients (in the emergency department or a hospital ward) with an acute onset of hypoxemia and  an acute onset of pulmonary infiltrates on their chest radiograph. Eligible participants must require a minimum of 4LPM (or greater) of supplemental oxygenation to maintain a PaO2 > 60mmHg or an arterial O2 saturation >90%.

Procedures (methods):  We will conduct a single center, proof of concept and feasability  trial of 30 subjects randomized to treprostinil or placebo.  Study drug will be administered via inhalation for up to 12 days.  The primary endpoint will be the change in the research subject's PaO2/FiO2 ratio.


MicroRNA-29 as a novel biomarker and regulator of aging.

 Co-Is:  Mohanish Deshmukh, Ph.D.; Eugenia Quackenbush, MD; Charles Cairns, MD

Sponsor: UNC Department of Cell Biology and Physiology; UNC Department of Emergency Medicine

Purpose: To evaluate miR-29 as a biomarker for aging in humans

Participants:  Patients of all ages presenting to the UNC Emergency Department for any reason

Procedures (methods):  Informed consent will be obtained. Biological specimens including blood and buccal swabs will be collected, along with medical history and diagnosis.   Samples will be transported to Dr Mohanish Deshmukh's lab for analysis of miR 29 to evaluate is as a biomarker for aging in humans. 

 

A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial

 PI: Stephan Moll, MD

Co-I:  Eugenia Quackenbush, MD

Sponsor:  Boehringer Ingelheim Pharmaceuticals, Inc.

Purpose:  The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran.

Participants:  The goal is to enroll approximately 250 patients at approximately 800 sites.

Diagnosis and main inclusion criteria:

  • Dabigatran-treated patients seen in the Emergency Department of a hospital who exhibit signs and symptoms of (overt) bleeding of sufficient severity to require medical intervention

                             OR

  • Dabigatran treated patients seen in the Emergency Department of a hospital who require emergency surgery or other medical procedure necessitating rapid reversal of the anticoagulant effect of dabigatran prior to medical intervention
  • Establish that the patient has been prescribed dabigatran.