Presentation on theme: "Joint Hemostatics In-Progress Review: Introduction"— Presentation transcript:
1 Joint Hemostatics In-Progress Review: Introduction 25 April 2012
2 Background: Causes of Death on the Battlefield All DeathsPotentially survivable: 19%OtherCentral Nervous SystemAirway CompromiseNon-survivable: 81%Potentially Survivable Deaths: 75% KIA and 25% DOWNon-survivable injuries:Catastrophic TBICardiac laceration / punctureThoracic great vessel injuryIntra thoracic tracheal injuryOpen pelvisTop cause of preventable DOW*:Hemorrhage 76%Burn 13%TBI 6%MOF 3%Airway 1%*DOW: Died of Wounds at Role 3+Hemorrhage: 84%33% Tourniquetable67% Non-compressible/ non-tourniquetable (internal injuries)Kelly et al., 2008
3 DoD Joint Program Committee for Combat Casualty Care Top Three Needs1. Improved ability to diagnose, resuscitate, and stabilize casualties with survivable wounds2. Improved ability to stop internal bleeding and external bleeding3. 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 develomentPurpose: 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 importantJoint/Interagency Steering Committee Role:Advise the JPC-6 and Service R&D programsReview overall program and provide recommendationsDevelop (and update) a DoD-level strategic planProduce recommendations and position papers regarding significant strategic level issues relevant to the programFacilitate harmonization of research requirements, objectives, and programs; ensure that Service-unique requirements are also metPromote communication and cooperation among programs
6 Strategic Approach: Major Efforts GoalImproved Blood ProductsDevelop safer and more logistically supportable blood products for transfusionDamage Control ResuscitationIdentify the best ways to use existing and newly developed blood products, drugs, and fluids (Including Transfusion Practice using existing products-CPGs)Coagulopathy of TraumaElucidate mechanisms to identify diagnostic and therapeutic targets for the development of rapid diagnostics and drugs to prevent or treat coagulopathy of traumaImmune/Inflammatory ModulationEvaluate promising approaches and identify key mechanisms leading to the long-term ability to modulate inflammatory responses of the patientMetabolic and Tissue StabilizationEvaluate promising approaches and identify key mechanisms leading to long-term ability to modulate/stabilize metabolic responses (Including oxygen delivery)HemostaticsEvaluate/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 bleedingAreas of research and testing in hemostaticsDARPA Wound Stasis Program to develop a field treatment for intracavitary bleedingHemostatic drugsDevices for junctional bleeding(CROC; hemostatic pellets)Other approaches to noncompressible hemorrhage(e.g. abdominal tourniquet)Endovascular hemostasisImproved topical hemostatics (Internal Use)Improved topical hemostatics (External Use)Improved limb tourniquetsPrimarilyR&DPrimarilyTesting
8 DoD Hemorrhage R&D Investment By Major Effort ($M) FY10FY11FY12FY13Improved Blood Products62.0042.8637.3043.37Damage Control Resuscitation55.6116.3311.2624.08Coagulopathy of Trauma12.0610.726.685.56Inflammatory Modulation5.718.083.093.39Metabolic and Tissue Stabilization16.7320.5217.7512.78Hemostatics19.5622.2115.558.75Total171.67120.7391.6397.92DoD Spending on hemostatics has been ~$15-20M/year and declining
9 StatusWe currently effective hemostatic dressings and limb tourniquets that are largely effectiveThe major technology gaps in hemostatics are Non-compressible and Junctional bleedingWe 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 themNeed improved coordination and communication to enhance efficiencyFunding 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 focusFrustration - user community that we are not testing dressings of interestFrustration - research community – why use S&T funds?
11 Some Recent ProgressRecent efforts to establish consensus testing approaches (with Inter-Service Agreement)DHP funding for FY12 – Dressings and TourniquetsPossible DHP 6.7 fundsImproved 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 OfficeDoD Hemorrhage and Resuscitation Research and Development Steering CommitteeOthers
13 Goals of the Conference Agree on a framework for linking needs, testing, and acquisition processes for hemostatic dressings and limb tourniquetsEstablish an agreed list of hemostatic dressings and limb tourniquets (and related topical hemostatics) that require testing in FY13Share latest testing data for hemostatic dressings and tourniquetsDefine/confirm standardized models for testingIdentify organization(s) that will/propose to perform testing for FY13 (Not-directive – requires chain of command approval, etc.)Identify funding source for testingDefine/revise desirable characteristics for new topical hemostatics and limb tourniquetsImprove integration with acquisition processesProvide a predictable forum for dissemination of information and planning
14 Key Coordinating Partners Defense Medical Materiel Program OfficeDoD Hemorrhage and Resuscitation R&D Steering CommitteeUSA 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 ServicesPurpose: To promote standardized medical supplies and equipment, joint interoperability of operational medical capabilities, and efficiency in the acquisition and lifecycle management of medical materiel
17 DiscussionDefine/revise desirable characteristics for hemostatic dressings and tourniquetsWhat 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 bleedingOf these:>half non-compressible (intracavitary) bleeding~one-fifth compressible (axilla, groin, neck) but junctional or otherwise difficult~one-third tourniquetableSource: 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? EfficacyWeightSizeDurabilityEase of useCostFlexibility/versatilityEffective with coagulopathyAdditional functionsOther1
21 DiscussionList of Hemostatic Dressings and Related Topical Hemostats for FY13 Testing
22 Generalized testing process Two-partScreeningGovernment organization (e.g. lab) assesses available data to determine if a screening test is warrantedLimited number/scopeMilitary experts provide early reality check and assessmentCompany may be required to pay for screeningJoint Military Efficacy Testing (JMET)Must be FDA approved (or near approval)Must be successful in screening using relevant modelMust be on the Joint listConsiderationWhat 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