Prospective Research Studies Currently Enrolling in the UNC ED

Prospective Research Studies Currently Enrolling Patients in the

UNC Emergency Department

To update: tplattsm@med.unc.edu

Questions: Contact specific contact for study

Last updated: December 16, 2015

 

Study Name: Better Back Care
Description: The goal is to improve care and outcomes in Medicare and Medicaid recipients with acute low back pain. Practitioners use a checklist during the history and physical and give standard patient education

PI: Dr. Amy Shaheen and Dr. Deb Bhowmick
Study Coordinator: Cassandra Miller
Contact e-mail:  shaheen@med.unc.edu / deb_bhowmick@med.unc.edu
Contact phone: 919-966-2276 (A. Shaheen)

 

Study Name: Brief Educational Tool To Enhance Recovery (BETTER)
Description: Randomized trial of usual care, an education video, or educational video plus phone follow-up for ED patients aged 50 and older with musculoskeletal pain. 
PI: Dr. Tim Platts-Mills
Study Coordinator: Natalie Richmond
Contact e-mail: tplattsm@med.unc.edu / nrichmonn@email.unc.edu
Contact phone: 559-240-6073 (T. Platts-Mills)

 

Study Name: Recovery After INjury (RAIN)
Description: Observational study on the impact of injury on physical activity among ED patients aged 60 and older with a musculoskeletal injury. RAs ask participants to perform 3 physical function assessments (patient may refuse) and to provide participants with an Actigraph watch.
PI: Dr. Tim Platts-Mills
Study Coordinator: Natalie Richmond
Contact e-mail: tplattsm@med.unc.edu / richmonn@email.unc.edu
Contact phone: 559-240-6073 (T. Platts-Mills)

Study Name:  Pilot Trial of Emergency Department Intervention and Referral for Alcohol Misuse in Older Adults  

Description:  The goal of this project is to perform a pilot, randomized, controlled trial of a brief intervention and referral for treatment among older adults in the emergency department (ED) with alcohol misuse. The pilot data would then be used to design a larger study. The intervention for this trial will consist of a Brief Negotiation Interview (BNI) with a stratified referral for further treatment, compared with usual care. The BNI is a standardized, well-described intervention that has been implemented in a broad range of clinical settings but has not been specifically tested in older adults in the ED. Following the BNI, we will provide a referral for further care for the patient that is stratified by severity of alcohol misuse. Patients with hazardous or harmful alcohol use will follow-up with a primary care physician; patients with alcohol abuse or dependence will follow-up with an outpatient alcohol and substance abuse program; those at risk for complicated withdrawal will be recommended for inpatient treatment.

PI:  Christina Shenvi

Study Coordinators:  Gait Jordan, Snigdha Peddireddy

Contact email:  clshenvi@gmail.com

Contact phone: 302-353-6766 (Christina Shenvi)

Study Name:  A Randomized Double-Blind, Phase 3 Study Comparing the Efficacy and Safety of High-Titer versus Low-Titer Anti-Influenza Immune Plasma for the Treatment of Severe Influenza A (IRC005)

Description:   The purpose of this study is to evaluate the efficacy and safety of treatment with high-titer versus low-titer anti-influenza immune plasma, in addition to standard care, in participants hospitalized with severe influenza A infection. This study will enroll people aged 2 weeks or older who are hospitalized with severe influenza A infection. Participants will be randomly assigned to receive either high-titer anti-influenza plasma or low-titer (control) anti-influenza plasma on Day 0. In addition, all participants will receive standard care antivirals. Participants will be assessed on Day 0 (baseline) and on Days 1, 2, 3, 7, 14, and 28. For participants who are not hospitalized on Days 2, 14, and 28, researchers may contact participants by telephone. Study procedures will include clinical assessments, blood collection, and oropharyngeal swabs.

PI:  Dr Eugenia Quackenbush

Study Coordinator:  Gait Jordan

Contact email: Eugenia_Quackenbush@med.unc.edu / gait@email.unc.edu

Contact phone:  919-843-2640 (Gait Jordan)

 

Study Name: MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department  (MERCURY PE)

Desciption:  This is a randomized, open-label, parallel-group, multicenter  study to evaluate low risk PE participants who are discharged from the ED and treated with rivaroxaban compared to participants who are treated with initial hospitalization and standard-of-care. The study consists of a Screening and Randomization Period, followed by a 90-day open-label treatment period, and an end of study/early withdrawal (EOS) visit. The duration of study participation for each participant is approximately 3 months. The participants will be randomized in a 1:1 ratio to one of two treatments.

PI:  Dr Eugenia Quackenbush

Study Coordinator:  Gait Jordan

Contact email: Eugenia_Quackenbush@med.unc.edu / gait@email.unc.edu

Contact phone:  919-843-2640 (Gait Jordan)

 

Study Name:  Treprostinil Sodium Inhalation for Patients At High Risk for ARDS

Description:  Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressing lung disease caused by a number of factors including pneumonia, sepsis and acute trauma that leads to reduced lung function and breathlessness. There are no pharmacological treatments approved for the treatment of ARDS. This pilot trial will study the safety and efficacy of Treprostinil sodium by inhalation for preventing the progression of acute hypoxemic respiratory failure to positive pressure ventilation and/or ARDS in patients at high risk.

PI:  Hubert J Ford, MD                            EM Co-investigator:  Eugenia Quackenbush

Study Coordinator:  Joyce Lanier, RRT     EM Coordinator:  Gait Jordan

Contact email:   joyce_lanier@med.unc.edu

Contact phone:  9199662531 (Joyce Lanier)

 

 

 

 

 

Study Name:  A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients 

Description:  This Phase IIIb outcome study in AHF patients is designed as a multicenter, randomized, double-blind, placebo-controlled, event-driven study in order to assess the efficacy, safety and tolerability of intravenous infusion of serelaxin or placebo. The AHF patients randomized to either serelaxin or placebo in the study will be followed for a period of 180 days, and are required to receive standard-of-care background HF management during both the index hospitalization and post discharge according to regional or local guidelines/institutional standards.

PI:  Kirkwood Adams                              EM Co-investigator:  Eugenia Quackenbush

Study Coordinator:  Shabina Sheikh                                 EM Coordinator:  Gait Jordan

Contact email:  Shabina_sheikh@med.unc.edu

Contact phone: 919-843-9937

 

Study Name:  Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding

Description:  A Phase 3 Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants, the primary outcome being stopping major bleeding within 24 hours of andexanet bolus.

PI:  Stephan Moll            EM Co-Is:  Eugenia Quackenbush, Abhi Mehrotra, Leah Hatfield, Justin Myers

Study Coordinator:  Gait Jordan

Contact email:  gait@email.unc.edu

Contact phone:  919-843-2640

 

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

Description:  Roche has developed a new method for quickly determining Troponin T levels from a patient's blood sample.  The purpose of this study is for the performance and labeling claims for the Roche's novel Troponin T assessment method. Safety and effectiveness of the method on existing Roche analyzers will be evaluated as an aid in the diagnosis of acute myocardial infarction.  Patients over age 21 who present to the ED with symptoms of ACS/myocardial ischemia will be identified and consented.  Four blood draws will be performed: at baseline, then again at 3 hours, 6-9 hours, then 12-24 hours after baseline.

PI:  Abhi Mehrotra

Study Coordinator:  Gait Jordan

Contact email:  gait@email.unc.edu

Contact phone:  919-843-2640