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This program is designed to support research examining early resuscitation of patients presenting in shock using the LifeFlow PLUS device, a simple hand-held tool for rapid delivery of fluids or blood products. LifeFlow was developed by 410 Medical and received FDA clearance for crystalloid administration in 2016, with subsequent clearance for blood and blood products in May 2020. Many hospitals and EMS agencies across the U.S. have adopted LifeFlow for the initial management of a wide variety of conditions including septic shock, anaphylaxis, post-ROSC hypotension, trauma, and obstetric or gastrointestinal hemorrhage. Accordingly, the intent of the LifeFlow Research program is to assist investigator-initiated resuscitation research. The research proposed by the applicant must be related to 410 Medical’s stated areas of research interest outlined below.
Sepsis is a life-threatening condition that results from the body’s overwhelming response to infection and affects millions of patients. In the U.S., over 200,000 people die each year, accounting for more deaths than prostate cancer, breast cancer and AIDS combined.
In patients with severe hemorrhage, every minute of resuscitation delay increases mortality. This is particularly true for traumatic brain injury patients. Standard methods of blood infusion are often too slow, particularly when vascular access is limited to smaller-gauge IV’s or IO. In-line warmers create additional resistance that may further slow infusion speed.
Shock requires immediate diagnosis and treatment, as symptoms can worsen quickly and permanent injury or death can result. Treatment protocols call for early, rapid, and controlled administration of fluids.
In children with decompensated shock from conditions such as hypovolemia, sepsis, hemorrhage, and anaphylaxis, rapid restoration of intravascular volume is required to correct hypotension and reverse shock. PALS guidelines specifically note that “early recognition and rapid intervention are critical to halting the progression from compensated shock to hypotensive shock to cardiopulmonary failure and cardiac arrest.”
Building on military experience in transfusing blood at the point of injury, EMS services have begun providing blood through ground and air ambulance services.