Development of a rapid, scalable, and deployable point-of-care blood volume diagnostic for monitoring postpartum and trauma-related hemorrhage

Quantiport, Inc., Portland OR

Investigators

Abstract

ABSTRACT Postpartum hemorrhage (PPH) is the leading cause of maternal mortality globally, accounting for 1/4th of all delivery-associated deaths. PPH is described as the cumulative blood loss of 1L or more with symptoms of hypovolemia within 24 hours after giving birth. Recently, reports have demonstrated that about 53-93% of PPH- related deaths could have been prevented by administering timely medical treatments and interventions. Currently, OB-GYNs use subjective visual assessments of blood loss and patient condition or semi-objective assessments of blood-soaked pads, drapes, and other materials that also absorb amniotic fluid, urine, and other excretions along with blood at delivery. We can certainly do better: This represents a great unmet and critical need given there is currently no quantitative method of assessing blood volume, or blood loss, to identify and direct PPH treatment decisions and interventions. To address this need and in direct response to NOT-EB- 21-001, QuantiPort is developing a novel rapid, scalable, deployable, easy-to-use, and inexpensive point- of-care BV diagnostic device to measure BV for postpartum and trauma-related hemorrhage in this NIH SBIR Phase I application. To measure BV, our team has developed a unique approach comprised of a non- imaging ultrasound transducer positioned on the skin, over a major blood vessel, which will quantify the intravascular concentration of a microbubble (MB) tracer agent (Sonazoid®, GE Healthcare) injected intravenously. The actual blood volume result can be obtained in under 3 minutes and assessments may be repeated every 20 minutes to provide quantitative measurements over time to determine the rate of blood loss or to assess the efficacy of therapeutic interventions. As the system design is simple and unwieldy, this small, lightweight device can easily fit into existing clinical workflows. The proposed MB tracer is safe, non-radiolabeled, has similar rheology to red blood cells to eliminate volumetric inaccuracies, and is stable at room temperature for months to years. To execute the proposed studies, our objectives for this application include: 1) building a manual non-imaging ultrasound system and optimizing the detection MB tracer agent using an in vitro vascular- flow phantom, and 2) performing proof-of-concept testing of the BV diagnostic in vivo in Japanese macaques at the Oregon National Primate Research Center. Successful execution of these studies will result in the development of a unique and novel ultrasound system to accurately measure BV in a rapid, portable, and cost- effective way for PPH and trauma care. Our goal is to ensure that QuantiPort’s device can effectively guide timely and actionable interventions to improve maternal morbidity and mortality due to PPH, which is a key intention of NOT-EB-21-001.