Management of External Hemorrhage in Tactical Combat Casualty Care: The Adjunctive Use of XStat™ Compressed Hemostatic Sponges: TCCC Guidelines Change 15-03.

Exsanguination from wounds in the so-called junctional regions of the body (i.e., the neck, the axilla, and the groin) was responsible for 19% of the combat fatalities who died from potentially survivable wounds sustained in Afghanistan or Iraq during 2001 to 2011. The development of improved techniques and technology to manage junctional hemorrhage has been identified in the past as a high-priority item by the Committee on Tactical Combat Casualty Care (CoTCCC) and the Army Surgeon General's Dismounted Complex Blast Injury (DCBI) Task Force. Additionally, prehospital care providers have had limited options with which to manage hemorrhage resulting from deep, narrow-track, penetrating trauma. XStat™ is a new product recently approved by the US Food and Drug Administration as a hemostatic adjunct to aid in the control of bleeding from junctional wounds in the groin or axilla. XStat has now been recommended by the CoTCCC as another tool for the combat medical provider to use in the management of junctional hemorrhage. The evidence that supports adding XStat to the TCCC Guidelines for the treatment of external hemorrhage is summarized in this paper.

Conceptualized Use of Self-Expanding Foam to Rescue Special Operators From Abdominal Exsanguination: Percutaneous Damage Control for the Forward Deployed.

BACKGROUND: Noncompressible hemorrhage is the leading cause of potentially survivable death on the battlefield. In Special Operations Forces (SOF), 50% of potentially survivable deaths have been related to noncompressible hemorrhage. Currently, there are no widely available presurgical interventions that can slow abdominal bleeding. Consequently, many of the preventable deaths occur en route to definitive care as a failure to rescue from exsanguination. A self-expanding polyurethane foam has been developed as a percutaneous damage control intervention to rescue casualties who would otherwise die of noncompressible hemorrhage, and allow them to survive long enough to reach surgical intervention. The purpose of this paper is to summarize the existing preclinical data, describe the role of SOF personnel in foam delivery-system development, and to integrate these together to conceptualize how foam could be incorporated into SOF medical care. METHODS: All existing publications on self-expanding foam are reviewed. Additionally, eight SOF medical providers with combat experience provided end-user input to delivery-device design through an interactive human-factors testing process. RESULTS: Ten preclinical publications described efficacy, safety, dose translation, and risk-benefit analysis of exsanguination rescue with percutaneous-foam damage control. SOF medical providers guided weight, cubic, operational requirements, and limits for the foam delivery device. CONCLUSION: Presurgical exsanguination rescue with percutaneous foam damage control is safe and effective with a favorable risk-benefit profile in preclinical studies. Battlefield, presurgical use by SOF medical providers is conceptually possible. Adoption of the technology on the battlefield should proceed with SOF medical provider input.

Safety and Effectiveness Evidence of SAM(r) Junctional Tourniquet to Control Inguinal Hemorrhage in a Perfused Cadaver Model.

BACKGROUND: Hemorrhage from the trunk?appendage junctions is a common, preventable cause of death on the battlefield. The recently U.S. Food and Drug Administration (FDA)-cleared SAM? Junctional Tourniquet (SJT) was designed to control out-of-hospital inguinal and axillary hemorrhage. The purpose of the present study was to provide safety and effectiveness data associated with use of the SJT. Such data provided support for regulatory clearance. METHODS: The SJT was tested in a perfused cadaver experiment simulating inguinal or axillary wound hemorrhage. RESULTS: No safety problems or tissue damage occurred, and flow normalized promptly after tourniquet removal. During SJT use, an average of 107 mmHg occluded the distal external iliac artery in an average of 7 seconds of inflation time; manual pressure as a control averaged 139 mmHg. In SJT use, an average of 739 mmHg occluded the axillary artery in an average of 5 seconds of inflation time; manual pressure as a control averaged 1237 mmHg. The control was a referent that achieved results that were similar in one body area but different in the other; both findings indicate the device is as safe as, if not safer than, manual compression. CONCLUSION: The SJT was shown to be safe and effective in hemorrhage control in a cadaver model for both the axillary and inguinal areas. The SJT's Target Compression Devices required pressures approximately equal to or lower than manual pressure to achieve hemostasis in these junctional regions.