Xstat

BACKGROUND: Hemorrhage control in prolonged field care (PFC) presents unique challenges that drive the need for enhanced point of injury treatment capabilities to maintain patient stability beyond the Golden Hour. To address this, two hemostatic agents, Combat Gauze (CG) and XSTAT, were evaluated in a porcine model of uncontrolled junctional hemorrhage for speed of deployment and hemostatic efficacy over 72-hours. METHODS: The left subclavian artery and subscapular vein were isolated in anesthetized male Yorkshire swine (70-85 kg) and injured via 50% transection, followed by 30-seconds of hemorrhage...

BACKGROUND: Exsanguination is the leading cause of preventable posttraumatic death, especially in the prehospital arena. Traditional hemorrhage control methods involve packing the wound with hemostatic agents, providing manual pressure, and then applying a pressure dressing to stabilize the treatment. This is a lengthy process that frequently destabilizes upon patient transport. Conversely, the iTClamp, a compact wound closure device, is designed to rapidly seal wound edges mechanically, expediting clot formation at the site of injury...

BACKGROUND: Exsanguination is the leading cause of preventable posttraumatic death, especially in the prehospital arena. Traditional hemorrhage control methods involve packing the wound with hemostatic agents, providing manual pressure, and then applying a pressure dressing to stabilize the treatment. This is a lengthy process that frequently destabilizes upon patient transport. Conversely, the iTClamp, a compact wound closure device, is designed to rapidly seal wound edges mechanically, expediting clot formation at the site of injury...

Although there are many hemostatic agents available for use on the battlefield, uncontrolled hemorrhage is still the primary cause of preventable death. Current hemostatic dressings include QuikClot® Combat Gauze (QCCG) and XStat®, which have inadequate success in reducing mortality. To address this need, a new hemostatic material was developed using shape memory polymer (SMP) foams, which demonstrate biocompatibility, rapid clotting, and shape recovery to fill the wound site. SMP foam hemostatic efficacy was examined in a lethal, noncompressible porcine liver injury model over 6 h following injury...

INTRODUCTION: Community consultation (CC) is a key step for exception from informed consent research. Using social media to conduct CC is becoming more widely accepted but has largely been conducted by single sites. We describe our experience of a social media-based CC for a multicenter clinical trial, coordinated by the lead clinical site. METHODS: Multicenter CC was administered by the lead site and conducted in preparation for a three-site prehospital randomized clinical trial...

Hemorrhagic shock is one of the leading causes of prehospital death in the armed forces. In this state, the body begins to shut down because of blood volume depletion. In both civilian and military trauma, a significant number of hemorrhage deaths occur in the first several hours after injury. Researchers all over the globe are working to develop relatively inexpensive and easy-to-transport products to prevent soldiers from going into hemorrhagic shock. For example, many advances have been made during the last several years toward the development of ideal hemostatic dressings...

In the United States, trauma claims the lives of over 150,000 civilians each year. In military settings, trauma and exsanguination result in 50% of combat related deaths. The majority of these deaths result from uncontrolled non-compressible hemorrhage. Non-compressible hemorrhage often results from deep vascular injuries within the torso, however can also occur secondary to penetrating injuries that involve the extremities. Given the high mortality rates for non-compressible hemorrhage, rapid and effective management of patients suffering from hemorrhage is essential to good patient outcomes...

BACKGROUND: Management of Non-Compressible Torso Hemorrhage (NCTH) consists primarily of aortic occlusion which has significant adverse outcomes, including ischemia-reperfusion injury, in prolonged field care paradigms. One promising avenue for treatment is through use of RevMedx XSTAT 30™ (an FDA approved sponge-based dressing utilized for extremity wounds). We hypothesized that XSTAT 30™ would effectively mitigate NCTH during a prolonged pre-hospital period with correctable metabolic and physiologic derangements...

Exsanguinating hemorrhage is a primary cause of battlefield death. The iTClamp is a relatively new device (FDA approval in 2013) that takes a different approach to hemorrhage control by applying mechanism wound closure. However, no previous studies have explored the feasibility of utilizing the iTClamp in conjunction with hemostatic packing. To fill this important gap in the literature, a novel swine model was developed, and a total of 12 trials were performed using QuikClot Combat Gauze or XSTAT sponges in conjunction with the iTClamp to treat arterial injuries through 5 cm or 10 cm skin incisions in the groin, axilla, or neck...

Uncontrolled blood loss is a major cause of preventable death worldwide. A severe injury can occur anywhere at any time. Controlling blood loss is an important issue for patient care in the hospital setting. Through the casualties of war, the lifesaving value of quick interventions was developed. Since 2001, new hemostatic agents have advanced the benefits of controlling blood loss. There are unforgettable lessons learned in the preventable deaths of many soldiers and should be passed on to the next generation of health care providers, to include all hospitals up to level I trauma hospitals...

BACKGROUND: Hemorrhage remains the leading cause of preventable death after trauma. The XSTAT expandable minisponge hemostatic device was developed for the control of severe, life-threatening bleeding from junctional wounds not amenable to tourniquet application. This is an initial report of the clinical use of this novel method of hemorrhage control for civilian penetrating injury. METHODS: A review of trauma admissions at a high-volume Level I trauma center was performed from July 2016 to November 2017...

BACKGROUND: Hemorrhage is associated with most potentially survivable deaths on the battlefield. Effective and field-tested products are lacking to treat junctional and noncompressible injuries. XSTAT® is a newly developed, U.S. Food and Drug Administration-approved product designed to treat junctional hemorrhage. The Committee on Tactical Combat Casualty Care has recently approved the product for use as part of its treatment guidelines, but data are lacking to assess its efficacy in different wounding patterns and physiologic states...

BACKGROUND: Although uterine tamponade is an effective treatment for postpartum hemorrhage (PPH), current methods have key limitations in their use, particularly in low resource settings. The XStat™ Mini Sponge Dressing (MSD) is approved for the management of non-compressible wounds in the battlefield/trauma setting. The MSD applies highly compressed medical sponges capable of stopping high-flow arterial bleeding within seconds. The objective of our study was to adopt the MSD for use in managing PPH...

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...