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Page 1: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Stephen Cohn, MD, FACS, UTHSC-SA

Page 2: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

NTI Science Committee

Subject matter experts Senior leadership In-depth knowledge/awareness of prior and current trauma research

Members: Peggy Knudson, MD, Chair Ellen J. MacKenzie, PhD

David B. Hoyt, MD, Vice-Chair Andrew B. Peitzman, MD

Timothy C. Fabian, MD Basil A. Pruitt, Jr., MD

Donald H. Jenkins, MD Ronald M. Stewart, MD

Gregory J. Jurkovich, MD

Page 3: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Science Committee Role

Determines priorities for each RFP, which is then broadly distributed

Reviews pre-proposals and issues invitations for full proposals

Evaluates proposals, makes proposal selections, and recommends awards and funding decisions to the Board

The Board, which includes representatives of Army, Air Force, and Navy, considers recommendations for full approval

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Page 4: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Review Criteria

Scientific merit Clinical relevance Clinical impact Innovation Feasibility of completing study on time Military relevance Appropriate budget Potential for follow-on studies Multicenter involvement

Page 5: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Proposals and Awards

April, 2010 85 pre-proposals from 25 states plus DC

15 invitations for full proposals

7 awarded studies, with 22 participating sites

January, 2011 92 pre-proposals from 25 states

21 invitations for full proposals

8 awarded studies, with 20 participating sites

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Page 6: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Pre-proposal Response

Page 7: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Award Distribution

16 Lead Sites

42 Participating Sites

Page 8: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

NTI Awarded Studies$3.8 million

Mycoplasma Pneumoniae in the ICU Dr. Joel Baseman, University of Texas Health Science Center

at San Antonio Timing and Mechanism of Traumatic Coagulopathy

Dr. Mitchell Cohen, University of California at San Francisco Evaluation of Ventilator Bundle in Injured Patients

Dr. Martin Croce, University of Tennessee Health Science Center at Memphis

Comparative Effectiveness of Clinical Care Processes in Resuscitation and Management of Moderate to Severe Traumatic Injuries

Dr. Shahid Shafi, Baylor Research Institute Comparison of IV Iron Supplementation to both

Enteral Supplementation and Placebo for the Anemia of Traumatic Critical Illness

Dr. Fred Pieracci, University of Colorado at Denver 8

Page 9: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Vasopressin Supplementation during Resuscitation of Hemorrhagic Shock

Dr. Carrie Sims, University of Pennsylvania

Characterization of the effects of the early Sex-Hormone Environment Following Injury

Dr. Jason Sperry, University of Pittsburgh The Safety and Efficacy of Platelet Transfusion in

Patients Receiving Antiplatelet Therapy that Sustain Intracranial Hemorrhage Mark Cipolle, Christiana Health Care System, Newark DE

Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia after Severe Trauma Jean-Francois Pittet, University of Alabama at Birmingham

Detection and Management of Non-Compressible Hemorrhage by Vena Cava Ultrasonography Jay J Doucet, University of California San Diego 9

Page 10: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Splenic Injury Prospective Outcomes Trial Ben Zarzaur, AAST/ PI: University of Tennessee Health Science

Center, Memphis TN Transfusion of Stored Fresh Whole Blood in a Civilian

Trauma Center: A Prospective Evaluation of Feasibility and Outcomes Gill Cryer, UCLA Dept of Surgery, Los Angeles, CA

Acute Lung Injury Ventilation Evaluation (ALIVE) Trial Suresh Agarwal, Boston Medical Center, Boston, MA

Methicillin-Resistant Staphylococcus aureus in a Trauma Population: Does Decolonization Prevent Infection? Robert Maxwell, Univ. of Tenn. HSC, Chattanooga, TN

Thrombelastography (TEG®) based dosing of enoxaparin for thromboprophylaxis: a prospective randomized trial Martin A Schreiber, Oregon Health & Science University,

Portland, OR Hepcidin and Anemia in Trauma

Lena M. Napolitano, Univ. of Michigan Health System, Ann Arbor MI

Page 11: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Research Project Awards:NTI Role/Responsibilities

Manages RFP and review process Manages regulatory compliance through

TATRC, HRPO, and USAMRMC Manages contracts Monitors scientific progress and prepares

reports Holds annual investigator meeting Sponsors annual trauma conference to

disseminate results, encourage investigators, and support military/civilian exchange

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Page 12: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Timing and Mechanism of Traumatic Coagulopathy

Wireless Vital Sign Monitor Project Mycoplasma Pneumoniae in the ICU

Page 13: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Stephen Cohn, MD, FACS, UTHSC-SA

Page 14: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Mycoplasma Pneumoniae in the ICU

Preliminary data showed M. pneumoniae common in ICU patients with suspected

VAP

associated with prolonged ventilator course

associated with poor oxygenation in subjects with ARDS

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Page 15: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Mycoplasma Pneumoniae in the ICU

Multicenter, prospective, observational study Investigating the role of Mycoplasma

pneumoniae in ICU patients with suspected ventilator-associated pneumonia (VAP)

Objectives are to: determine the incidence of M. pneumoniae

infection among critically ill ventilator-dependent subjects

evaluate the impact of this pathogen on ICU outcomes

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Page 16: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Mycoplasma Pneumoniae in the ICU

Apply novel diagnostic assays targeting the Community Acquired Respiratory Distress Syndrome (CARDS) toxin

Subjects undergo routine bronchoscopy with bronchoalveolar lavage (BAL) for the diagnosis of VAP

Samples of BAL fluid and serum collected Polymerase chain reaction (PCR) assessment for

CARDS toxin gene sequences BAL tested for CARDS toxin protein Serum assayed for anti-CARDS toxin antibodies Additional serum samples collected to test for

seroconversion16

Page 17: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Mycoplasma Pneumoniae in the ICU

Research will: Determine the incidence of M. pneumoniae

Determine the ventilator course and ICU outcomes

Determine the physiologic implications of M. pneumoniae in this setting

Expand upon preliminary findings from a single hospital

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Page 18: Stephen Cohn, MD, FACS, UTHSC-SA. NTI Science Committee  Subject matter experts  Senior leadership  In-depth knowledge/awareness of prior and current

Mycoplasma Pneumoniae in the ICU

First study to employ these novel assays for the rapid detection of M. pneumoniae infection in the ICU

First study to systematically evaluate the contribution of this pathogen to pulmonary dysfunction in critically ill subjects.

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