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

开发快速、可扩展且可部署的护理点血容量诊断，用于监测产后和创伤相关出血

• 批准号: 10603819
• 负责人: LAWRENCE J BUSSE
• 金额: $ 23.13万
• 依托单位: QUANTIPORT, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603819
• 关键词: Accounting; Address; Albumins; Amniotic Fluid; Animal Model; Animals; Birth; Blood; Blood Tests; Blood Vessels; Blood Volume; Calibration; Cessation of life; Clinical; Colloids; Computer software; Critical Care; Data; Detection; Development; Devices; Diagnostic; Diagnostic Equipment; Electronics; Erythrocytes; Excision; Excretory function; Experimental Models; Goals; Healthcare; Hemorrhage; Hour; Hypovolemia; Hypovolemics; In Vitro; Intention; Intervention; Intravenous; Japanese Monkey; Life; Liquid substance; Manuals; Maternal Health; Maternal Mortality; Measurement; Measures; Medical; Methods; Microbubbles; Modeling; Monitor; Morbidity - disease rate; Oregon; Outcome; Patients; Performance; Persons; Phase; Physicians; Physiological; Positioning Attribute; Postpartum Hemorrhage; Postpartum Period; Primates; Radiolabeled; Reporting; Reproducibility; Research; Research Subjects; Resuscitation; Rheology; Signal Transduction; Skin; Small Business Innovation Research Grant; Speed; Sterile coverings; Symptoms; System; Techniques; Technology; Temperature; Test Result; Testing; Therapeutic Effect; Therapeutic Intervention; Time; Tracer; Transducers; Trauma; Ultrasonic Transducer; Ultrasonography; United States National Institutes of Health; Urine; Visual; absorption; advanced system; clinically significant; commercialization; cost; cost effective; design; diagnostic strategy; efficacy evaluation; improved; in-vivo diagnostics; light weight; maternal morbidity; mortality; novel; phase 1 study; point of care; point-of-care diagnostics; portability; prevent; preventable death; prototype; response; standard of care; trauma care; ultrasound; underserved community

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.

抽象的 产后出血（PPH）是全球孕产妇死亡的主要原因，占全球1/4 交付相关的死亡。 PPH被描述为1L或更多的累积失血，症状 分娩后24小时内低血症。最近，报告表明，约有53-93％的人口 可以通过及时的医疗治疗和干预措施来阻止相关死亡。 目前，ob-gyn使用失血和患者状况或半目标的主观视觉评估 对还吸收羊水，尿液和其他的血液浸泡垫，窗帘和其他材料的评估 排泄物以及分娩时的血液。我们当然可以做得更好：这代表了一个很棒 需要给出目前没有评估血量或失血的定量方法来识别和 直接PPH治疗决策和干预措施。解决这一需求并直接响应不eb- 21-001，Quantiport正在开发一种新型的快速，可扩展，可部署，易于使用且廉价的点 - 在此NIH中测量产后和创伤相关出血的BV的护理诊断装置 SBIR I期应用程序。为了衡量BV，我们的团队已经开发了一种独特的方法，该方法完成了非 - 成像放置在皮肤上的超声传感器，在主要的血管上，这将量化 注射微泡（MB）示踪剂（Sonazoid®，GE Healthcare）的血管内浓度 静脉注射。实际的血量结果可以在3分钟内获得，评估可能是 每20分钟重复一次以随着时间的推移提供定量测量以确定失血率 或评估理论干预措施的效率。由于系统设计简单而笨拙，因此 轻量级设备很容易适合现有的临床工作流程。拟议的MB示踪剂是安全的，不标记的， 具有与红细胞相似的流动性，以消除体积不准确，并且在室温下稳定 几个月到几年。为了执行拟议的研究，我们对此应用的目标包括：1）建造 手动非成像超声系统，并使用体外血管 - 优化MB示踪剂 流幻影和2）在日本猕猴中对BV诊断进行概念验证测试 俄勒冈州国家灵长类动物研究中心。这些研究的成功执行将导致 开发独特而新颖的超声系统，以快速，便携式和成本量准确测量BV PPH和创伤护理的有效方法。我们的目标是确保Quantiport的设备可以有效地指导及时指导 以及可行的干预措施，以改善由于PPH引起的孕产妇发病率和死亡率，这是 非EB-21-001。