Extracorporeal Life Support (ECLS)

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Materiel Agency (USAMMA) technology objectives. Strategic oversight for the award(s) supported by this RPP will be provided by USAMMA.

Technical Background: Current military conflicts have exposed service members to complex injuries and combat polytrauma. The signature injuries currently seen are combinations of blast injuries (improvised explosive devices), penetrating wounds (projectiles and gunfire) and blunt force trauma, often accompanied by hemorrhagic shock and infection. Each of these injuries puts casualties at risk of multisystem organ failure, but in combination have led to alarming rates of respiratory and renal failure. The use of conventional lung rescue strategies on standard ventilators, including lung protective ventilation, airway pressure release ventilation (APRV-a ‘rescue’ ventilator mode), and proning, can prove challenging to rescue severe cases. Additionally, the lack of expertise, equipment, and resources limit therapeutic capability.

The physiologic burden of injury-related sequela is not limited to the lungs, as renal failure occurs in up to 12.5% of patients and contributes to mortality in nearly 30% of combat casualties. A combination of shock, prolonged hypotensive resuscitation, and tissue damage from a blast leads to rhabdomyolsis, acute kidney injury (AKI), and renal failure. Temporary renal replacement therapy can be lifesaving in these cases, as untreated traumatic renal failure has an unacceptably high mortality.

In an effort to address these critical gaps in the most injured casualties, several strategies have emerged. An extracorporeal membrane oxygenation (ECMO) lung rescue team currently exists that can be launched from the United States to any Role 3 facility on the battlefield. This team has the expertise and is equipped to be able to cannulate patients on site and initiate full ECMO. ECMO is a strategy to bring the blood of the patient outside of the body through a circuit that will add oxygen and remove carbon dioxide, bypassing the compromised lung. ECMO generally requires large cannulas that can accommodate blood flows up to 5 L/min and requires specialized training. For renal failure, several Role 3 level assets have temporary renal replacement therapy (RRT) capability. Temporary RRT functions similar to ECMO, but operates at much lower blood flows (200-400 ml/min). Carbon dioxide (CO2) removal operates at similar flow rates as RRT and uses the same catheter sizes. This partial lung support can protect the lungs from injurius ventilation and has the potential to allow for avoidance of ventilation entirely. There are emerging uses for this therapy in trauma and combat casualty care, but it requires a more robust regulatory strategy at this time.

With the changing landscape of combat operations, and the mandate to provide up to 72 hours of prolonged care in the field, sicker patients will present to forward deployed Military Treatment Facilities (MTFs). These patients have potential for significant ischemia-reperfusion injury with resultant AKI and acute respiratory distress syndrome (ARDS). Therefore, there is a critical need to develop a single "bridge" extracorporeal life support (ECLS) device that can be used in patients with both AKI and ARDS. The goal of this bridge therapy is to keep patients alive until more definitive support and transport can be achieved. This device must be able to fully support CO2 removal while replacing the function of the kidneys through a standard dialysis catheter.

Though the military would most likely use the bridge ECLS device at a level 3 hospital facility, where more robust resources allow for adequate staffing, there may be a need to push farther forward, to the Role 2 if necessary, depending on the availability of evacuation assets. A device to meet the requirements would need to be lightweight, rugged, modular, and use-friendly for implementation in both the field and for transport during fixed or rotary wing medical evacuation. The device would also have to be designed for use by any critical care medical provider with minimal training. Ideally, such a device could be scalable, allowing for full ECMO capability at higher echelons of care.

Finally, the device would have to be air worthy. Air worthiness is determined using standards that allow equipment to be flown in air evacuation platforms, such as a sturdy frame that can withstand vibration, elevation changes, and rapid turning; a sealed container that can withstand environmental elements; and the low emission of electronic signals that do not interfere with airframe avionics.

Follow-on: The intent of the Government is to develop and procure such an ECLS device. Therefore, the Government reserves the right to continue development of an ECLS prototype resulting from this RPP through a separate Other Transaction Agreement (OTA) or other agreement as necessary. Obviously the degree that a prototype meets the stated clinical requirements as well as its utility in multiple field locations will dictate if further action is taken after this solicitation effort.

Military Relevance: Military relevance is a critical component of proposal submission. USAMMA is a unique and multifaceted organization that acts as the Army Surgeon General’s central focal point and Executive Agent for strategic medical logistics programs and initiatives. The Agency’s mission is to develop, acquire, provide, and sustain world class solutions and capabilities to enable medical readiness globally. Project Management Office, Medical Devices (PMO-MD) provides lifecycle management of advanced development and commercial medical devices supporting field medical organizations globally. This PMO provides oversight for technology, engineering, and manufacturing development efforts utilizing Defense Health Program (DHP) and Army Research, Development, Test, and Evaluation (RDT&E) funds.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.