Selecting research Priorities and studies

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Selecting research Priorities and studies

• Stephen Cohn, MD, FACS, UTHSC-SA

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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

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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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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

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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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Pre-proposal Response
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Award Distribution
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NTI Awarded Studies3.8 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

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• 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

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• 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

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Research Project AwardsNTI 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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select NTI Funded Studies

• Timing and Mechanism of Traumatic Coagulopathy
• Wireless Vital Sign Monitor Project
• Mycoplasma Pneumoniae in the ICU

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Mycoplasma Pneumoniae in the ICU

• Stephen Cohn, MD, FACS, UTHSC-SA

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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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Mycoplasma Pneumoniae in the ICU

• Multicenter, prospective, observational study
• Investigating the role of Mycoplasma pneumoniae
  in ICU patients with suspected ventilator-associat
  ed pneumonia (VAP)
• Objectives are to
• determine the incidence of M. pneumoniae
  infection among critically ill ventilator-dependen
  t subjects
• evaluate the impact of this pathogen on ICU
  outcomes

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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
  seroconversion

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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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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.