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Prevention of postpartum hemorrhage: identifying pregnant women at risk and determining the safe and effective use of tranexamic acid using state-of-the-art pharmacokinetic/pharmacodynamics modeling

预防产后出血：利用最先进的药代动力学/药效学模型识别处于危险中的孕妇并确定氨甲环酸的安全有效使用

基本信息

批准号：
10406309
负责人：
Homa Khorrami Ahmadzia
金额：
$ 15.52万
依托单位：
GEORGE WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-15 至 2024-04-30
项目状态：
已结题

项目摘要

Project Summary/Abstract The primary goal of this proposal is to help further my development into an independent investigator in the area translational and clinical peripartum hemostasis research. With my clinical background in Maternal-Fetal Medicine and research experiences in epidemiologic and translational study methods, I am ideally positioned to succeed through the NIH K23 Career Mentored Development Award mechanism. The proposed study focuses on improving methods to identify women at risk for postpartum hemorrhage and evaluate the optimal dosing of tranexamic acid (TXA) for prevention in at risk women. The specific aims are as follows: 1) To improve the statistical risk prediction model for deliveries requiring blood transfusion, 2) To conduct a prospective clinical pharmacokinetic study using TXA prophylactically at time of delivery, and 3) To determine the pharmacodynamics (PD) of TXA in peripartum period and explore pre-delivery markers to predict peripartum blood transfusion. Collectively, these aims will better identify women at greatest risk for severe postpartum hemorrhage and determine the optimal dosing and effects of TXA on hemostasis when used for prevention of hemorrhage. I have identified excellent mentors and collaborators/advisors on her research team to help accomplish the outlined aims. The multidisciplinary nature of the project justifies a larger mentorship team in order for me to be successful. The primary mentor is Dr. John van den Anker, an internationally recognized expert in pharmacokinetic research and translational studies who is well-funded by NIH. My three other co-mentors include Dr. Madeline Rice, a senior epidemiologist at the GW Biostatistics Center, Dr. Richard Amdur, a senior biostatistician at GW Medical Faculty Associates and Dr. Naomi Luban, an internationally recognized and NIH-funded pediatric transfusion medicine expert. Important to my successful completion of Aim 2 is collaboration with GW obstetric anesthesiologist Dr. Jeffrey Berger. Finally, two additional senior investigators and internationally recognized experts are Dr. Alisa Wolberg and Dr. Andra James. Their collaboration and career mentorship will help ensure my success during and especially beyond this award. I will participate in coursework and focused workshops as well as hands-on training designed to promote investigator independence. I will benefit from an ideal working environment, rooted in the Clinical and Translational Science Institute partnering GW and Children’s National Medical Center but also extended through supplemental training at the GW Biostatistics Center and Dr. Wolberg’s hemostasis and thrombosis lab. In summary, this proposal sets forth aims that are significant, innovative and feasible, and will provide me with the tools and mentorship to develop into an independent investigator working to better understand how peripartum hemostasis can be optimized using tranexamic acid.

项目概要/摘要该提案的主要目标是帮助我进一步发展成为该领域的独立调查员围产期止血的转化和临床研究。凭借我在母胎方面的临床背景流行病学和转化研究方法方面的医学和研究经验，我处于理想的位置通过 NIH K23 职业指导发展奖机制取得成功。拟议的研究重点是改进方法来识别有产后出血风险的妇女并评估最佳方案氨甲环酸 (TXA) 的剂量用于高危女性的预防。具体目标如下： 1）改进需要输血的分娩的统计风险预测模型，2) 进行在分娩时预防性使用 TXA 进行前瞻性临床药代动力学研究，以及 3) 确定围产期 TXA 的药效学 (PD) 并探索产前标志物进行预测围产期输血。总的来说，这些目标将更好地识别面临严重重症风险的女性产后出血并确定 TXA 用于止血时的最佳剂量和效果预防出血。我在她的研究团队中找到了优秀的导师和合作者/顾问帮助实现概述的目标。该项目的多学科性质证明需要更大的指导团队，让我取得成功。主要导师是约翰·范·登·安克 (John van den Anker) 博士，他是一位国际药代动力学研究和转化研究领域公认的专家，得到 NIH 的大力资助。我的三其他共同导师包括 GW 生物统计中心的高级流行病学家 Madeline Rice 博士、 Richard Amdur 是 GW 医学院的高级生物统计学家，Naomi Luban 博士是国际公认且由 NIH 资助的儿科输血医学专家。对我的成功很重要目标 2 的完成是与 GW 产科麻醉师 Jeffrey Berger 博士合作完成的。最后，两个其他高级研究人员和国际公认的专家是 Alisa Wolberg 博士和 Andra 博士詹姆斯.他们的合作和职业指导将有助于确保我在工作期间和之后的成功这个奖项。我将参加课程作业和重点研讨会以及旨在促进研究者的独立性。我将受益于植根于临床和临床的理想工作环境转化科学研究所与 GW 和儿童国家医疗中心合作，但也扩大了合作范围通过GW生物统计中心和Wolberg博士的止血和血栓形成补充培训实验室。综上所述，本提案提出的目标是重大的、创新的、可行的，将为我提供参考。借助工具和指导，发展成为一名独立调查员，更好地了解如何使用氨甲环酸可以优化围产期止血。

项目成果

期刊论文数量（12）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

National trends in tranexamic acid use in the peripartum period, 2015-2019.

DOI：
10.1007/s11239-020-02141-4
发表时间：
2020-10
期刊：
Journal of thrombosis and thrombolysis
影响因子：
4
作者：
Ahmadzia HK;Hynds EB;Amdur RL;Gimovsky AC;James AH;Luban NLC
通讯作者：
Luban NLC

The association between body mass index and postpartum hemorrhage after cesarean delivery.

DOI：
10.1038/s41598-023-38526-7
发表时间：
2023-07-25
期刊：
SCIENTIFIC REPORTS
影响因子：
4.6
作者：
Whitley, Julia;Dazelle, Wayde;Kripalani, Shawn;Ahmadzia, Homa
通讯作者：
Ahmadzia, Homa

Improving Development of Drug Treatments for Pregnant Women and the Fetus.

DOI：
10.1007/s43441-022-00433-w
发表时间：
2022-11
期刊：
THERAPEUTIC INNOVATION & REGULATORY SCIENCE
影响因子：
1.5
作者：
David, Anna L.;Ahmadzia, Homa;Ashcroft, Richard;Bucci-Rechtweg, Christina;Spencer, Rebecca N.;Thornton, Steve
通讯作者：
Thornton, Steve

Pharmacoethics and pregnancy: Overcoming the therapeutic orphan stigma.

药物伦理学和怀孕：克服治疗孤儿耻辱。