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Landscape: Hemorrhagic Preventable Death Richard L. Alcorta, MD FACEP State EMS Medical Director

Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

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Page 1: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

Landscape: Hemorrhagic Preventable Death

Richard L. Alcorta, MD FACEP

State EMS Medical Director

Page 2: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

• 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,

Page 3: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

• 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

Page 4: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

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? •

Page 5: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

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)

Page 6: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

Current EMS Issues

• Limited Effectiveness of “Tie-on Pressure Dressings”

• Spectrum of Hemostatic Products – Powders – Impregnated Gauzes

• Limited Knowledgeable EMS Medical Direction

Page 7: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

• No Good IV Pro-Coagulant/ Oxygen Carrying Alternative to Whole Blood – Crystalloids – Hetastarch – Plasma Expander

• Lyophilized Freeze Dried Plasma Promising but not FDA approved

Page 8: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication
Page 9: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

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

Page 10: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

Tourniquets in

EMS

Page 11: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

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)

Page 12: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

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

Page 13: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

“Injectable” Wound Sponges

• Old Concept Wound Packing - Made New • Effective in Confined Space • Need More Post Market Data

Page 14: Landscape: Hemorrhagic Preventable Death - fda.gov Hemorrhagic Preventable Death . Richard L. Alcorta, ... Anti-Tourniquet ... • Civilian Rarity of Indication

Summary

• Improved Education of Evidence Base Recommendations

• Tourniquets Save Lives • Junctional Tourniquets (Military definitely) • Hemostatic Agents (Aftermarket

Evaluations) • “Injectable” Wound Sponges