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，占孕产妇死亡率的 1/4 分娩相关死亡被描述为累计失血 1L 或更多，并伴有以下症状： 最近的报告表明，约 53-93% 的 PPH- 会在产后 24 小时内出现低血容量。 通过及时的医疗和干预措施，相关死亡是可以避免的。 目前，妇产科医生使用主观视觉评估失血量和患者状况或半客观评估 对浸有血的垫子、手术单和其他也吸收羊水、尿液和其他物质的材料进行评估 我们当然可以做得更好：这是一个巨大的未满足和关键的问题。 鉴于目前没有评估血量或失血量的定量方法来识别和 直接 PPH 治疗决策和干预措施以满足这一需求并直接响应 NOT-EB-。 21-001，QuantiPort 正在开发一种新颖的快速、可扩展、可部署、易于使用且廉价的点- 该 NIH 中用于测量产后和创伤相关出血 BV 的非护理 BV 诊断装置 为了测量 BV，我们的团队开发了一种由非 SBIR 组成的独特方法。 成像超声换能器位于皮肤上的主要血管上方，这将量化 注射微泡 (MB) 示踪剂（Sonazoid®，GE Healthcare）的血管内浓度 静脉注射可在 3 分钟内获得实际血容量结果并可进行评估。 每 20 分钟重复一次，以提供一段时间内的定量测量结果，以确定失血率 或评估治疗干预的功效由于系统设计简单且笨重，所以这个小， 轻型设备可以轻松融入现有的临床工作流程。所提出的 MB 示踪剂是安全的、非放射性标记的、 与红细胞具有相似的流变性，可消除体积误差，并且在室温下稳定 为了执行拟议的研究，我们此应用程序的目标包括：1）建立一个 手动非成像超声系统并使用体外血管优化检测MB示踪剂 流模型，以及 2) 在日本猕猴体内进行 BV 诊断的概念验证测试 俄勒冈国家灵长类研究中心的成功执行将导致 开发独特新颖的超声系统，以快速、便携且成本低廉的方式精确测量 BV 我们的目标是确保 QuantiPort 的设备能够有效及时指导。 以及采取可行的干预措施，以改善产后产后出血 (PPH) 导致的孕产妇发病率和死亡率，这是 非-EB-21-001。