Joint Hemostatics In-Progress Review: Introduction

1. Joint Hemostatics In-Progress Review:Introduction 25 April 2012

2. Background:Causes of Death on the Battlefield All Deaths Potentially survivable: 19% Other Central Nervous System AirwayCompromise Non-survivable: 81% Potentially Survivable Deaths: 75% KIA and 25% DOW • Non-survivable injuries: • Catastrophic TBI • Cardiac laceration / puncture • Thoracic great vessel injury • Intra thoracic tracheal injury • Open pelvis • Top cause of preventable DOW*: • Hemorrhage 76% • Burn 13% • TBI 6% • MOF 3% • Airway 1% • *DOW: Died of Wounds at Role 3+ Hemorrhage: 84% 33% Tourniquetable 67% Non-compressible/non-tourniquetable (internal injuries) Kelly et al., 2008

3. DoD Joint Program Committee for Combat Casualty Care Top Three Needs 1. Improved ability to diagnose, resuscitate, and stabilize casualties with survivable wounds 2. Improved ability to stop internal bleeding and external bleeding 3. Improved therapy for hemorrhagic shock and head injury

4. DoD Hemorrhage and Resuscitation Program/Portfolio Scope and Purpose • Scope: The Hemorrhage and Resuscitation R&D program includes DoD efforts in the general areas of hemorrhage control, fluid resuscitation, blood products, transfusion, and pathophysiologic responses to traumatic hemorrhage, with a view ranging from basic and discovery research through clinical develoment • Purpose: Conduct research and development to provide improved methods, drugs, and devices to stop bleeding, restore lost blood volume, and mitigate the consequences of hemorrhage. Reduce mortality by up 16% overall.

5. Steering Committee Role • The present combination of Service programs, major Defense Health Program initiatives, significant CSI efforts, and numerous smaller initiatives make coordination extremely important • Joint/Interagency Steering Committee Role: • Advise the JPC-6 and Service R&D programs • Review overall program and provide recommendations • Develop (and update) a DoD-level strategic plan • Produce recommendations and position papers regarding significant strategic level issues relevant to the program • Facilitate harmonization of research requirements, objectives, and programs; ensure that Service-unique requirements are also met • Promote communication and cooperation among programs

6. Strategic Approach:Major Efforts

7. DoD Activities in Hemostatics • The major gaps in hemostatics: • Non-compressible and Junctional bleeding • Areas of research and testing in hemostatics • DARPA Wound Stasis Program to develop a field treatment for intracavitary bleeding • Hemostatic drugs • Devices for junctional bleeding • (CROC; hemostatic pellets) • Other approaches to noncompressible hemorrhage • (e.g. abdominal tourniquet) • Endovascular hemostasis • Improved topical hemostatics (Internal Use) • Improved topical hemostatics (External Use) • Improved limb tourniquets Primarily R&D Primarily Testing

8. DoD Hemorrhage R&D Investment By Major Effort ($M) DoD Spending on hemostatics has been ~$15-20M/year and declining

9. Status • We currently effective hemostatic dressings and limb tourniquets that are largely effective • The major technology gaps in hemostatics are Non-compressible and Junctional bleeding • We continue to test new dressings and tourniquets (for “tourniquetable” and compressible hemorrhage)

10. Issues • Lack of agreement on why (what gap are we trying to fill?) • Disagreements on what dressings and tourniquets to test and how to test them • Need improved coordination and communication to enhance efficiency • Funding is declining – need to ensure we are focusing (limited) resources on the right priorities • “Testing” takes away resources from research and development efforts – need alternative funding and need focus • Frustration - user community that we are not testing dressings of interest • Frustration - research community – why use S&T funds?

11. Some Recent Progress • Recent efforts to establish consensus testing approaches (with Inter-Service Agreement) • DHP funding for FY12 – Dressings and Tourniquets • Possible DHP 6.7 funds • Improved coordination still needed

12. Approach • Joint In-progress Review on Hemostatics • This will be the first of a series of recurring meetings (probably 1x/yr in person and 1x/yr conference call) • Recommended by the Joint Program Committee for Trauma (JPC-6) • Endorsed by: • Principal Assistant for Acquisition, USAMRMC (Dr. Bertram, SES) • Army Combat Casualty Care Research Program (RAD2; COL Hack) • Defense Medical Materiel Program Office • DoD Hemorrhage and Resuscitation Research and Development Steering Committee • Others

13. Goals of the Conference • Agree on a framework for linking needs, testing, and acquisition processes for hemostatic dressings and limb tourniquets • Establish an agreed list of hemostatic dressings and limb tourniquets (and related topical hemostatics) that require testing in FY13 • Share latest testing data for hemostatic dressings and tourniquets • Define/confirm standardized models for testing • Identify organization(s) that will/propose to perform testing for FY13 (Not-directive – requires chain of command approval, etc.) • Identify funding source for testing • Define/revise desirable characteristics for new topical hemostatics and limb tourniquets • Improve integration with acquisition processes • Provide a predictable forum for dissemination of information and planning 

14. Key Coordinating Partners • Defense Medical Materiel Program Office • DoD Hemorrhage and Resuscitation R&D Steering Committee • USA Medical Materiel Acquisition Activity

15. Defense Medical Materiel Program Office Mission: To recommend clinical, logistics, and program policy, as well as to support medical materiel development and acquisition processes across the four Services Purpose: To promote standardized medical supplies and equipment, joint interoperability of operational medical capabilities, and efficiency in the acquisition and lifecycle management of medical materiel

16. Questions/Comments

17. Discussion Define/revise desirable characteristics for hemostatic dressings and tourniquets What are the gaps that we are trying to fill for Limb Tourniquets and Hemostatic Dressings?

18. Potentially Salvageable Deaths • Up to 16% of all combat deaths could be saved with new technologies to control or treat bleeding • Of these: • >half non-compressible (intracavitary) bleeding • ~one-fifth compressible (axilla, groin, neck) but junctional or otherwise difficult • ~one-third tourniquetable Source: Kelly JF, et al. Injury severity and causes of death from Operation Iraqi Freedom and Operation Enduring Freedom: 2003-2004 versus 2006. J Trauma. 2008;64(2):S21-S27.

19. Desirable characteristics/technology gaps for improved dressings and tourniquets? Characteristics • Efficacy • Weight • Size • Durability • Ease of use • Cost • Flexibility/versatility • Effective with coagulopathy • Additional functions • Other • 1

20. Characteristics (Continued)

21. Discussion List of Hemostatic Dressings and Related Topical Hemostats for FY13 Testing

22. Generalized testing process • Two-part • Screening • Government organization (e.g. lab) assesses available data to determine if a screening test is warranted • Limited number/scope • Military experts provide early reality check and assessment • Company may be required to pay for screening • Joint Military Efficacy Testing (JMET) • Must be FDA approved (or near approval) • Must be successful in screening using relevant model • Must be on the Joint list • Consideration • What are you testing versus what is the desirable characteristic (e.g. a dressing may be lower cost but the same efficacy)?

23. Lists • Recommended List for Screening • Recommended List for JMET • Recommended List for R&D

24. List of Dressings to Test • JMET • 1 Screening • 1 R&D • 1

25. Discussion List of LimbTourniquets for FY13 Testing

26. List of Limb Tourniquets to Test • JMET • 1 Screening • 1 R&D • 1