landscape: hemorrhagic preventable death - fda.gov hemorrhagic preventable death . richard l....
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Landscape: Hemorrhagic Preventable Death
Richard L. Alcorta, MD FACEP
State EMS Medical Director
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• CDC indicate that traumatic injuries in 2008 accounted for 181,226 deaths.
• NHTSA MVCs in 2010 were responsible for 32,885 deaths and 2,239,000 injures.
• 2010 interpersonal violence and falls were responsible for 20,000 and 31,600 deaths,
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• Death from road injuries was the fifth leading cause of death, exceeded only by death from ischemic heart disease, lung cancer, stroke, and chronic obstructive pulmonary disease.
Bulger, E: NHTSA: Efficacy of Prehospital Application of Tourniquets and Hemostatic Dressings To Control Traumatic External Hemorrhage
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External Hemorrhage
• An analysis by Kauvar et al. of the National Trauma Data Bank for the years 2002–2005 found a 2.8% death rate among patients with an “isolated lower extremity trauma with an arterial component.” Among the same set of patients, 6.5% suffered amputations.
• Preventable? •
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Current EMS Issues
• Most EMS providers rely on direct pressure, pressure dressings, pressure points and elevation to treat severe extremity hemorrhage, using tourniquets only as a last resort.
• Direct Pressure only - Anti-Tourniquet Protocols (Military vs Civilian Transport Time)
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Current EMS Issues
• Limited Effectiveness of “Tie-on Pressure Dressings”
• Spectrum of Hemostatic Products – Powders – Impregnated Gauzes
• Limited Knowledgeable EMS Medical Direction
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• No Good IV Pro-Coagulant/ Oxygen Carrying Alternative to Whole Blood – Crystalloids – Hetastarch – Plasma Expander
• Lyophilized Freeze Dried Plasma Promising but not FDA approved
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Tourniquets • Tourniquet variability
– Provider Made Caveat – Manufacture reliability and effectiveness – Change in evacuation from scene to
definitive care • Timeliness of Application and Duration of
Application
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Tourniquets in
EMS
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Junctional Tourniquets
• Civilian Rarity of Indication • Timeliness of Application (Survival to
EMS Arrival?) • Civilian vs Military Mechanisms of Injury • Cost per Ambulance (Maryland has 750
Public Safety and 442 Commercial)
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Hemostatic Agents
• Pre-release Data validation (safety and efficacy)
• Post release monitoring – “Untoward” reporting - Historic demonstration exothermic injury to tissues – – Device Monitoring Data Set
(NEMSIS / NTDB) • Tremendous variety of products and little
to guide EMS Medical Directors decision
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“Injectable” Wound Sponges
• Old Concept Wound Packing - Made New • Effective in Confined Space • Need More Post Market Data
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Summary
• Improved Education of Evidence Base Recommendations
• Tourniquets Save Lives • Junctional Tourniquets (Military definitely) • Hemostatic Agents (Aftermarket
Evaluations) • “Injectable” Wound Sponges