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Research Center Profile:
Staten Island University Hospital

Center Information

Barry Hahn
Research Director
Staten Island University Hospital
475 Seaview Avenue
Staten Island, NY 10305
USA
718-226-3215
201-820-0383 (fax)
barry_hahn@siuh.edu
www.siuhresearch.com/
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Therapeutic Areas

Cardiology/Vascular Diseases
Dental and Oral Health
Devices
Immunology
Infections and Infectious Diseases
Musculoskeletal
Nephrology
Pediatrics/Neonatology
Pharmacology/Toxicology
Pulmonary/Respiratory Diseases
Trauma (Emergency, Injury, Surgery)

Center Overview

Staten Island University Hospital, a Level I trauma, 714-bed, specialized teaching hospital provides care to Staten Island, the New York metropolitan region and to patients from around the world. The hospital is a tertiary care, medical center with over 95,000 emergency department visits per year. Our population includes individuals from a wide range of cultural and socioeconomic backgrounds.

Staten Island University Hospital is a 911-receiving center. Separate adult and pediatric emergency services and a full time urgent care center, are staffed by board certified emergency physicians. Specialized services are provided in the Emergency Department continuously and include a Stroke Team, Cardiac Cath Team and Burn Center. An on site laboratory and pharmacy function 24 hours a day and each has experience in conducting clinical trials.

The Emergency Department clinical research group is comprised of a "hands-on" primary investigator and two full time clinical research coordinators. Electronic data capture has been utilized to conduct phase II and III trials in a variety of therapeutic areas. These include critical care, cardiology, pulmonary medicine, pediatrics, vascular medicine and trauma. Broadband internet connection as well as state of the art medical equipment and research facilities are available. We maintain an excellent working relationship with the local institutional review board and various departments in the hospital. We are strongly committed to maintaining GCP and continue to meet, and often times surpass, our subject enrollment goals. We at Staten Island University look forward to working with you!

Performance Metrics

Number of Studies Conducted: 22
Number of Studies Actually Completed: 17
Number of Active Patients in the Database: 10
Regulatory Submission Turn-Around Time: 3 Month(s)
Average Number of Total Patients Enrolled: 20
Average Percent of Total Patients Randomized: 90%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 95%
EDC Capabilities: Yes

Clinical Research Experience

Our patients and expertise include the following areas:

  • Asthma
  • Burn / Wound Care
  • Cardiology
  • Critical Care
  • Devices
  • Disease Markers
  • Hematology
  • Infectious Disease
  • Pain
  • Pediatrics
  • Pulmonary
  • Quality Improvement
  • Toxicology
  • Trauma
  • Vascular

Clinical / Grant Funded Study Experience:

  • A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Patients with Acute Asthma
  • Multi-marker INdex for the Diagnosis of Sepsis in the Emergency DepartmenT (MINDSET)
  • National Emergency Department Safety Study (NEDSS)
  • Sublingual Capnometry for Rapid Determination of the Severity of Hemorrhagic Shock
  • Congestive Heart Failure Clinical Specimen Collection Study
  • Clinical Specimen Collection Study - Renal Failure Population
  • Sensitivity and Specificity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in an Emergency Room Population
  • A Phase 3 Randomized, Double-blind, Parallel-group. Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization
  • Increased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration (INFUSE-Pediatric Rehydration Study): Subcutaneous Rehydration with Recombinant Human Hyaluronidase (hylenex) compared to Intravenous Rehydration in Infants and Young Children with Mild to Moderate Dehydration
  • INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration (INFUSE-Pediatric Rehydration Study): Phase IV Study of Subcutaneous Rehydration with Recombinant Human Hyaluronidase (Hylenex) for Infants and Children
  • Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock
  • An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX┬« P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin derivatives in subjects requiring emergency surgery or invasive intervention
  • An open-label, randomized, multicenter, Phase IIIb study to assess the efficacy, safety, and tolerance of Beriplex┬« P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin derivatives in subjects with acute major bleeding
  • An Open-Label, Multiple-Dose, Multiple-Day, Non-Randomized, Single-Arm Safety Study of Repeat-Doses of DIC075V (Intravenous Diclofenac Sodium) in Patients with Acute PostOperative Pain
  • A Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study to Estimate the Safety, Tolerability, and Efficacy of NXL104/Ceftazidime vs. Imipenem Cilastatin Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections in Hospitalized Adults
  • A Multi-Center, Randomized, Open-Label, Parallel, Active-Comparator, Multiple Dose Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Pediatric Patients
  • CPI-NAC-001: A Multi-center, Double-blind, Randomized, Controlled Study to Determine the Efficacy and Safety of a New Formulation of Acetylcysteine Injection.
  • Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (the ATTRACT Trial)
  • The Performance of the AppyScore™ Test in the Evaluation of Possible Acute Appendicitis in Children, Adolescents and Young Adults Presenting to the Emergency Department — Study number CP12-001

Facility Description

Clinical staff are available around the clock to evaluate and consent potential subjects. Coordinators are experienced with EDC, eCRF, IVRS, FACTS, data fax, portals, and data upload for central reading. All potential subjects are initially screened and monitored via our computerized emergency department information system (EDIS). Once patients are admitted, charts can be viewed via an electronic medical record.

We maintain a comfortable and spacious area for site monitoring with high speed internet, convenient retrieval of subject records, source documents, and CRFs, including pharmacy records. Limited EMR system access can granted for monitoring purposes.

Lab:
We have the ability to draw and process our own blood samples. There is a fully accredited, on-site lab open 24 hours a day.

A microbiologist is available to prepare and store isolates for shipment to a central lab. We have a -17 degree celsius freezer available. Laboratory staff is experienced in the handling and packaging of specimens with dry ice.

Pharmacy:
SIUH has an on-site central pharmacy which is operational 24 hours a day. There is also a satellite pharmacy available in the emergency department.

Study medications can be stored at room temperature or refrigerated in a secure manner in either of these locations.

We have experience randomizing patients to study drug assignment using an IVRS (Interactive Voice Response System).

IRB: We utilize a local IRB which meets monthly. Submission deadline is 2 weeks prior to the upcoming meeting date. Approval letters are typically received within one week of IRB approval.

The SIUH IRB allows for a surrogate consent process (i.e., consent by legally authorized representative)

IRB contact information:
Offices of the IRB
North Shore LIJ Health System & Staten Island University Hospital
The Feinstein Institute for Medical Research
350 Community Drive
Manhasset, NY 11030
(516) 562-3101
irb@nshs.edu

Regulatory:
Contracts and Budgets are all reviewed by in-house staff. Both can be reviewed independently from the IRB process.

The protocol and consent document do not have to be reviewed by any committee other than the IRB.

Transportation / Parking:
Staten Island is located minutes away from New York City, Brooklyn and New Jersey. The hospital is close to all major airports. The facility is easily accessible and valet parking is available.

Investigator Experience

Barry Hahn, MD, FACEP
Director of Research

Dr. Hahn is the founder and director of the clinical trials research division in the Department of Emergency Medicine at Staten Island University Hospital. He has a hands-on mentality and research experience in a broad range of pharmaceutical and device products. He is the author of numerous publications in peer reviewed journals.

Dr. Hahn began working at Staten Island University Hospital in 2004 after completing an emergency medicine residency and chief resident year at Kings County Hospital / SUNY Downstate in Brooklyn, NY. He maintains an associate professorship at SUNY Downstate.

Dr. Hahn is a board certified emergency medicine physician. He is a fellow of the American College of Emergency Physicians as well as a member of the American Board of Emergency Medicine and the Society for Academic Emergency Medicine. He has been a member of the local IRB since 2009. Dr. Hahn also functions as the Research Director for the emergency medicine program at Staten Island University Hospital.

Staff Expertise

Maria Scibilia, RN
Clinical Research Coordinator

Maria Scibilia, a registered nurse, has been a clinical research coordinator in the Department of Emergency Medicine at Staten Island University Hospital since 2008.

In 2004 she received her Bachelor of Science Degree from Wagner College located in Staten Island, New York. After graduating from Wagner College, she has worked as an Emergency Room nurse for Staten Island University Hospital, New York Methodist Hospital and Columbia Presbyterian Hospital.

Currently, she has been working on clinical and academic trials at Staten Island University Hospital, where she also has been working toward incorporating the hospital staff to aid in the recruitment of potential study participants.

Gabriella Taflin, RN
Clinical Research Coordinator

Gabriella Taflin, a registered nurse, is a clinical research coordinator for the Department of Emergency Medicine at Staten Island University Hospital. She is a graduate of St. Paula's School of Nursing located on Staten Island, NY and obtained her undergraduate degree from Pace University located in Pleasantville, NY.

Gabriella joined the Research Department in 2011 and coordinates many studies and trials extending from the Emergency Department into Intensive Care Unit, Critical Care Unit, and Pediatrics. Gabriella has been well equipped to coordinate enrollment of potential research subjects and continues to work on clinical and academic trials at Staten Island University Hospital.

Patient Demographics

We are always ranked among the highest enrolling sites in trials we participate in. This is because of our extensive patient population. The emergency department sees over 95,000 visits per year. All patients visiting the emergency department and outpatient facilities are screened for potential study enrollment.

An estimated that 500,000 people live in Staten Island. Our target population consists of the following and includes males and females of all age groups:

  • 75.7% White (65.8% non-Hispanic White alone)
  • 10.2% Black or African American (9.6% non-Hispanic Black or African American alone)
  • 0.2% American Indian and Alaska Native
  • 7.4% Asian
  • 4.6% other
  • 1.9% two or more races

Hispanics or Latinos of any race made up 15.9% of the population.

Contact Center

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