Project Summary and Abstract
This supplement requests support of effort for key individuals that will allow the Wayne State University site for
the Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) to continue operations as a Hub
titled Michigan SIREN Collaborative for recruiting participants into emergency care research. Supplemental
support is requested to maintain operations between the end of regular funding for the first 5 years of SIREN
and start of the second 5 years of SIREN. Uninterrupted support of the Hub will ensure successful enrollment
of participants into the ongoing SIREN trials at our Hub and spokes; ICECAP, BOOST-3, and HOBIT. We will
continue to support the ancillary studies for these trials: PRECICECAP, Bio-BOOST and BIO-HOBIT.
Our specific Aims remain:
1) Exemplary execution of pre-hospital and ED-based clinical trials, through our well-established, collaborative
clinical partnership that has long espoused the goal of advancing emergency care. Leveraging our track record
of successful performance, we prioritize:
a. Facilitation of rapid start up, including streamlined agreements and centralized regulatory approval;
b. Shared infrastructure to ensure enrollment of at least 100 patient/yr in four or more active studies over
the five years, including mobile intervention teams, and centralized training with internal “certification” of all
research staff involved in SIREN activities
c. Unmitigated fidelity to study protocols, including timely provision of accurate data.
2) Considerable expertise in the recruitment and retention of minority and other difficult to reach emergency care
patient populations, with a focus on:
a. Community partnerships to demonstrate the value added aspects of the SIREN network.
b. Long-term commitment to improving the health, and health care of patients, family members, and other
caregivers across the state of Michigan.
c. Enriching the overall diversity of SIREN by including patients within distinct racial and ethnic subgroups
across the spectrum of socioeconomic and psychosocial circumstances.
3) Exceptional collaborators from the major population centers, healthcare systems and academic environments
in the state of Michigan, many of whom have had a long-standing dedication to NIH funded research and
community based initiatives, inclusive of:
a. Well-established, municipal and private EMS divisions in metropolitan Detroit, Ann Arbor, and Grand
Rapids providing access to a collective population of more than 5,000,000 individuals;
b. Medical and surgical specialty and sub-specialty content experts from WSU, the University of Michigan,
Michigan State University, and Oakland University in the areas of emergency medicine, neurology,
cardiology, pulmonology, neurosurgery, trauma surgery, cardiothoracic surgery, hematology, anesthesiology
and critical care.
c. A large core of established investigators (many with existing NIH funding) considered innovators and
leaders in areas that are directly relevant to SIREN such as cardiac arrest, cerebral resuscitation, traumatic
brain injury, sepsis, blunt and penetrating trauma, hypertension, heart failure and pulmonary edema, vascular
emergencies, and acute myocardial ischemia/infarct.
d. Access and support from the CTSA program located within the Michigan Institute for Clinical & Health
Research and the Acute and Critical Care Clinical Trial Node at the University of Michigan.