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
Airway Compromise
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
Goal
Improved Blood Products
Develop safer and more logistically supportable blood products for transfusion
Damage Control Resuscitation
Identify the best ways to use existing and newly developed blood products, drugs, and fluids (Including Transfusion Practice using existing products-CPGs)
Coagulopathy of Trauma
Elucidate mechanisms to identify diagnostic and therapeutic targets for the development of rapid diagnostics and drugs to prevent or treat coagulopathy of trauma
Immune/Inflammatory Modulation
Evaluate promising approaches and identify key mechanisms leading to the long-term ability to modulate inflammatory responses of the patient
Metabolic and Tissue Stabilization
Evaluate promising approaches and identify key mechanisms leading to long-term ability to modulate/stabilize metabolic responses (Including oxygen delivery)
Hemostatics
Evaluate/identify existing products and develop new products or procedures to control bleeding

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)
FY10
FY11
FY12
FY13
Improved Blood Products
62.00
42.86
37.30
43.37
Damage Control Resuscitation
55.61
16.33
11.26
24.08
Coagulopathy of Trauma
12.06
10.72
6.68
5.56
Inflammatory Modulation
5.71
8.08
3.09
3.39
Metabolic and Tissue Stabilization
16.73
20.52
17.75
12.78
Hemostatics
19.56
22.21
15.55
8.75
Total
171.67
120.73
91.63
97.92
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: versus J Trauma. 2008;64(2):S21-S27.

19. Desirable characteristics/technology gaps for improved dressings and tourniquets?
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
Screening 1
JMET 1
R&D 1

25. Discussion List of LimbTourniquets for FY13 Testing

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