Emergency|Graduate|Undergraduate|Nurse Anesthesia|Medical Laboratory Science|Library

Welcome

Recent
Publications

EM Conferences

Clinical Protocols

Ongoing
Research

Useful Emergency Medical Links

 

The Emergency Department at Pennsylvania Hospital has developed a robust and broad-ranging clinical research program. Administered by Pamela Henderson, BSN, RN, our research projects include some that are based in the ED and others in which the primary responsibility for the clinical care of the patients is shared with other specialists.

Current projects include:

A Randomized, Multicenter, Blinded Study of the Efficacy and Safety of High-Dose (750mg), Short-Course (3-5 days)Levofloxacin Therapy in Uncomplicated and Complicated Acute Bacterial Exacerbation of Chronic Bronchitis
An Epidemiological Observational Study of Deep Vein Thrombosis (DVT)
Sixteenth Multicenter Airway Research Collaboration
(MARC-16)
Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines: The CRUSADE National Quality Improvement Initiative
A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients with Prolonged Immobilization
Clinical Protocol for Evaluating the Distribution of Albumin Cobalt (ACB‘) Test Results in Patients with Conditions Other Than Ischemic Heart Disease
A Prospective, Open-Label, Randomized, Parallel-Group Investigation to Evaluate the Safety of Enoxaparin Versus Unfractionated Heparin in Subjects who Present to the Emergency Department with Acute Coronary Syndrome


Study:

A Randomized, Multicenter, Blinded Study of the Efficacy and Safety of High-Dose (750mg), Short-Course (3-5 days) Levofloxacin Therapy in Uncomplicated and Complicated Acute Bacterial Exacerbation of Chronic Bronchitis

Sponsor:

Ortho-McNeil Pharmaceuticals

PAH Investigators:

Charles V. Pollack, Jr., MA, MD, FACEP
Susan A. Gregory, MD, FACP, FACCP

Rationale:

Levfloxacin given once daily has been studied in multiple large clinical trials and doses of 500mg once daily for seven days resulted in safe and effective treatment of ABECB. Since levofloxacin is a concentration-dependent killing antibacterial it is expected that high-dose, short course treatment will successfully treat ABECB. Several factors argue in favor of reducing therapy to the shortest duration that is effective and these include cost, improved compliance, and the total number of potential adverse events. An additional reason, however, may be equally important. Years of antibacterial use have indicated that resistance development is most closely associated with the amount of drug used. Therefore, it is expected that a higher dose, shorter course treatment will help prevent the emergence of resistance.

This is a Phase 3B protocol in which patients with both uncomplicated and complicated (the differentiation based on validated clinical criteria) acute bacterial exacerbation of chronic bronchitis (ABECB) will be studied.

The primary objective of this study for the uncomplicated ABECB severity group is to establish the clinical efficacy and safety of high-dose, short-course levofloxacin compared to azithromycin.

The primary objective of this study for the complicated ABECB severity group is to establish the clinical efficacy and safety of high-dose, short-course levofloxacin compared to amoxicillin/clavulanate.

[back to top]

Study:

An Epidemiological Observational Study of Deep Vein Thrombosis (DVT)

Sponsor:

Genecom

PAH Investigators:

Charles V. Pollack, Jr., MA, MD, FACEP
Shane Edward Ruckle, MD
Paul Anthony Andrulonis, Jr., MD

Rationale:

DVT is a significant public health problem with the potential both for significant morbidity (DVT with loss of productivity, post-phlebitic syndrome) and for mortality (pulmonary embolism). This study is an epidemiological survey of approximately 7500 patients in comprehensive effort to establish a DVT registry and to study DVT and its treatment. It will provide historical data on patients, including demographic information, risk factors and prophylaxis measures. It will also provide direction for focusing the future prevention initiatives.

Dr. Pollack serves on the Steering Committee of the DVT-FREE Initiative.

[back to top]

Study:

Sixteenth Multicenter Airway Research Collaboration (MARC-16)

Sponsor:

Abbott Pharmaceuticals

PAH Investigators:

Charles V. Pollack, Jr., MA, MD, FACEP
Shane Edward Ruckle, MD
Paul Anthony Andrulonis, Jr., MD

Rationale:

Large-scale ED-based research on CAP is lacking, despite at least 2 million CAP-related visits to US EDs each year. Furthermore, much of the existing pneumonia data ignores the research questions pertinent to the ED population and the distinct characteristics of practice in this setting. These characteristics have significant impact on the use of care plans to improve care. There is a pressing need to support ED-based CAP research in a variety of topic areas, such as diagnosis and treatment (e.g., utility of diagnostic tests, accuracy of test interpretation, selection and timing of antimicrobial treatments, admission and discharge criteria), prevention (e.g., influenza vaccination and treatment), education, and economic evaluation (e.g., drug choice and health outcome, health care utilization, etc).

This study will evaluate the resistance patterns of Streptococcus pneumoniae organisms cultured in sputum samples and evaluate the clinical response to treatment with Biaxin XL.

[back to top]

Study:

Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines: The CRUSADE National Quality Improvement Initiative

Sponsor:

Duke Clinical Research Institute

PAH Investigators:

Charles V. Pollack, Jr., MA, MD, FACEP
Shane Edward Ruckle, MD
Paul Anthony Andrulonis, Jr., MD
Howard L. Haber, MD, FACP, FACC

Rationale:

The optimal evaluation and management strategies for patients with acute coronary syndrome who do not have ST-segment elevation continue to evolve. In response to an explosive increase in studies of these patients and their outcomes over the past several years, the American College of Cardiology (ACC) and American Heart Association (AHA) published in September of 2000 an extensive treatment guideline for these patients. Initial feedback from emergency physicians, cardiologists, and hospitals indicates that the guidelines are not being closely followed. This is particularly important in the care of patients objectively identified as being “high risk”: those with new ST-segment depression, an extended duration or accelerated pace of angina, sustained ventricular ectopy, advanced age, or with elevated cardiac troponin levels. CRUSADE is a national quality improvement initiative aimed at monitoring compliance with the ACC/AHA guidelines, for high-risk patients, over time. CRUSADE hospitals will also be offered educational materials (site reports, comparative reports, educational conferences, etc) to assist in improving compliance.

Dr. Pollack serves on the Executive Committee of the CRUSADE Initiative.

back to top]

Study:

A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients with Prolonged Immobilization

Sponsor:

Aventis Pharmaceuticals

PAH Investigators:

Charles V. Pollack, Jr., MA, MD, FACEP
Susan A. Gregory, MD, FACP, FACCP
Howard L. Haber, MD, FACP, FACC
David C. Chang, MD
Dara G. Jamieson, MD
R. Michael Buckley, Jr., MD
Judy A. Somers, MD
Kathleen Nasci, MD
Paul Anthony Andrulonis, Jr., MD
Shane Edward Ruckle, MD

Rationale:

VTE is a major public health concern in medically ill immobilized patients. In several other studies, LMWH has been show to significantly reduce the incidence of DVT, but it is likely that the standard treatment duration of 10+/-4 days may be too brief for some patients and that it is discontinued while they are still at risk for DVT. An extension of the prophylaxis may result in further risk reduction of VTE in medically ill patients.

This study will evaluate the efficacy and safety of extended VTE prophylaxis with enoxaparin for 28+/-4 days compared to placebo, both following 10+/-4 days of initial treatment with enoxaparin.

[back to top]

Study:

Clinical Protocol for Evaluating the Distribution of Albumin Cobalt (ACB‘) Test Results in Patients with Conditions Other Than Ischemic Heart Disease

Sponsor:

Ischemia Technologies

PAH Investigators:

Charles V. Pollack, Jr., MA, MD, FACEP
Judy A. Somers, MD
Kathleen Nasci, MD
Paul Anthony Andrulonis, Jr., MD
Shane Edward Ruckle, MD

Rationale:

There are well-accepted biochemical markers for cardiac necrosis which are used to aid in the diagnosis of myocardial infarction. However, there are no proven and accepted biochemical markers for ischemia. The Albumin Cobalt Binding Test (ACB Test‘), is under investigation as a biochemical marker for ischemia. Although the sensitivity of the ACB test in detecting ischemia-modified albumin in patients with coronary ischemia appears to be high, the specificity requires further investigation. This clinical study is designed to characterize the distribution of ACB Test results in individuals with diseases other than ischemic heart disease, with particular emphasis on other ischemic conditions, and other conditions which might masquerade as ischemic heart disease or acute cardiac ischemia.

*We expect to begin this protocol in the near future.

[back to top]

Study:

A Prospective, Open-Label, Randomized, Parallel-Group Investigation to Evaluate the Safety of Enoxaparin Versus Unfractionated Heparin in Subjects who Present to the Emergency Department with Acute Coronary Syndrome

Sponsor:

Aventis Pharmaceuticals

PAH Investigators:

Charles V. Pollack, Jr., MA, MD, FACEP
Shane Edward Ruckle, MD
Paul Anthony Andrulonis, Jr., MD

Rationale:

This study will evaluate patients who present to the ED and are diagnosed with non-ST segment elevation ACS, including unstable angina and non-ST-segment elevation MI. Therapy for these conditions has evolved over the last decade and several studies have shown the superiority of combined antiplatelet and anticoagulant treatment over antiplatelet therapy alone. Enoxaparin has been approved in the US for prevention of ischemic complications in USA and non-Q-wave MI, but it is not widely used in the ED setting. This study will compare the efficacy and safety of enoxaparin and unfractioned heparin in this patient population.

*We expect to begin this protocol in the near future.


Dr. Pollack is the national co-PI for RESCUE-ACS.

[back to top]

 



About Penn Medicine   Contact Us   Site Map   Privacy Statement   Legal Disclaimer   Terms of Use

Penn Medicine, Philadelphia, PA 800-789-PENN © 2013, The Trustees of the University of Pennsylvania