Validation of a pediatric thrombosis risk assessment model and characterization of bleeding in hospitalized children through the Children's Hospital Acquired Thrombosis (CHAT) Consortium

通过儿童医院获得性血栓 (CHAT) 联盟验证儿科血栓风险评估模型和住院儿童出血特征

• 批准号: 10673606
• 负责人: Julie Ann Jaffray
• 金额: $ 17.13万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673606
• 关键词: Address; Adult; Anticoagulants; Anticoagulation; Area; Award; Biological Assay; Blood coagulation; Calibration; California; Case/Control Studies; Characteristics; Child; Child Care; Childhood; Clinical; Clinical Research; Clinical Trials; Computerized Medical Record; Data; Development; Diagnosis; Discrimination; Disease; Dose; Drug Monitoring; Enrollment; Environment; Event; Faculty; Focus Groups; Funding; Future; Goals; Health; Health Care Costs; Hemoglobin; Hemorrhage; Hospitalization; Hospitalized Child; Hospitals; Incidence; Information Technology; Inpatients; Institution; Intervention Trial; Interview; Knowledge; Knowledge acquisition; Laboratories; Life; Location; Logistic Regressions; Los Angeles; Lung; Measures; Medical; Mentored Patient-Oriented Research Career Development Award; Mentors; Methods; Mission; Modeling; Monitor; Morbidity - disease rate; Multicenter Studies; Multivariate Analysis; Names; Newly Diagnosed; Nurses; Outcome; Pain; Patients; Pediatric Hospitals; Pediatrics; Pharmaceutical Preparations; Phase; Physicians; Populations at Risk; Prevention; Prevention strategy; Provider; Publishing; Qualitative Research; ROC Curve; Random Allocation; Randomized, Controlled Trials; Registries; Research; Research Design; Research Personnel; Risk; Risk Assessment; Risk Factors; Safety; Sampling; Severities; Signs and Symptoms; Specialist; Standardization; Structure; Target Populations; Thrombosis; Time; Training; Transcript; United States National Institutes of Health; Universities; Validation; Venous Insufficiency; aged; blood product; career; career development; cohort; deep vein; demographics; density; design; disability; effective intervention; efficacy evaluation; experience; high risk; implementation science; improved; indexing; inpatient service; large datasets; member; mortality; pediatric patients; prevent; prophylactic; prospective; skill acquisition; skills; standard of care; success; training opportunity; uptake; venous thromboembolism

PROJECT SUMMARY/ABSTRACT Venous thromboembolism (VTE), a serious and life-threatening condition, has increased in incidence for hospitalized pediatric patients by 70-200%. This has led to increased morbidity, mortality and longer hospitalizations, and is thought to be due to more effective care of children with serious and life-threatening disorders. Unfortunately, it is unclear which children are at the highest risk of hospital acquired (HA) VTE and how to prevent these events due to many studies being single center with small case numbers. This study addresses the critical need to identify children at a high risk of HA-VTE using a risk assessment model (RAM), but a low risk of bleeding. This cohort will be used as the target population for trials evaluating the efficacy and safety of prophylactic anticoagulation in order to progress towards the long term goal of HA-VTE prevention in children. The overall objectives of this study are to (1) prospectively validate a pediatric HA-VTE RAM created through Dr. Jaffray’s multi-center Children’s Hospital Acquired Thrombosis (CHAT) Consortium using a case-control study design and electronic medical record review (EMR); (2) evaluate the incidence and characterization of bleeding in hospitalized children on and off anticoagulation through EMR review; and (3) explore barriers to provider engagement with RAM implementation by conducting focus groups and semi- structured interviews of inpatient medical teams using qualitative thematic analysis strategies. To achieve these research aims, Dr. Jaffray has the immediate career goals to obtain new knowledge, skills, and experience that will allow her to (1) analyze data from large datasets from multicenter studies and build and validate risk models through multivariate analysis; (2) develop qualitative research skills to design and analyze focus groups and semi-structured interviews; and (3) acquire the knowledge to plan and conduct randomized controlled trials. Achieving these career goals will support her long term career goal of becoming an independently funded, leader in the effort to determine efficacious and safe VTE prevention strategies in children through multicenter randomized controlled trials. Dr. Jaffray will accomplish her research and training aims with the support of her primary mentor, Dr. Guy Young (pediatric thrombosis clinical research), and co-mentors, Dr. Neil Goldenberg (pediatric clinical trial research), Dr. Ernest Amankwah (biostatics), Dr. Neil Zakai (adult thrombosis clinical research) and Dr. Elizabeth Burner (qualitative research). Dr. Jaffray’s plan for career development is enhanced by the outstanding research environment at Children’s Hospital Los Angeles and The University of Southern California, which provides junior faculty members with numerous didactic and training opportunities designed specifically to facilitate the transition to research career independence. By completing her research and training aims, Dr. Jaffray will take the first necessary step in identifying children at high risk of HA- VTE who may safely benefit from prevention strategies and subsequently reduce the incidence of pediatric VTE.

项目总结/摘要 静脉血栓栓塞（VTE）是一种严重的危及生命的疾病， 住院儿科患者减少70- 200%。这导致了发病率、死亡率的增加， 住院治疗，并被认为是由于更有效地照顾儿童的严重和危及生命的 紊乱不幸的是，目前尚不清楚哪些儿童患医院获得性（HA）VTE的风险最高， 由于许多研究是单中心研究，病例数较少，因此如何预防这些事件。本研究 解决了使用风险评估模型识别HA-VTE高风险儿童的迫切需要 (RAM)，但出血风险低。该队列将被用作评价以下指标的试验的目标人群： 预防性抗凝治疗的有效性和安全性，以实现HA-VTE的长期目标 儿童预防。本研究的总体目的是（1）前瞻性验证儿童HA-VTE 通过Jaffray博士的多中心儿童医院获得性血栓形成（CHAT）联盟创建的RAM 使用病例对照研究设计和电子病历审查（EMR）;（2）评估发病率， 通过EMR审查住院儿童接受和不接受抗凝治疗的出血特征;（3） 通过开展焦点小组和半 采用定性主题分析策略对住院医疗团队进行结构化访谈。实现 这些研究目标，贾夫雷博士有直接的职业目标，以获得新的知识，技能， 经验，使她能够（1）分析来自多中心研究的大型数据集的数据，并建立和 通过多变量分析验证风险模型;（2）发展定性研究技能，以设计和分析 焦点小组和半结构化访谈;（3）获得计划和进行随机 对照试验。实现这些职业目标将支持她成为一名 独立资助，在努力确定有效和安全的儿童静脉血栓栓塞预防策略的领导者 通过多中心随机对照试验。Jaffray博士将完成她的研究和培训目标， 她的主要导师Guy Young博士（儿科血栓形成临床研究）和共同导师的支持， 博士Neil Goldenberg（儿科临床试验研究）、Ernest Amankwah博士（生物统计学）、Neil Zakai博士（成人 血栓形成临床研究）和伊丽莎白·伯纳博士（定性研究）。贾弗雷博士的职业规划 洛杉矶儿童医院的优秀研究环境和 南加州大学，为初级教师提供大量的教学和培训 专门为促进向研究职业独立过渡而设计的机会。通过完成 她的研究和培训目标，贾夫雷博士将采取必要的第一步，确定儿童在高风险， HA- VTE患者可安全地从预防策略中获益，并随后降低儿童VTE的发生率 VTE。