MANAGEMENT OF PATIENTS WITH SUSPECTED PULMONARY EMBOLISH

疑似肺栓塞患者的处理

• 批准号: 6499110
• 负责人: SUMAN W RATHBUN
• 金额: $ 12.91万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-02-15 至 2006-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6499110
• 关键词: anticoagulants; blood tests; clinical research; computed axial tomography; dimer; drug withdrawal; health care cost /financing; health care service evaluation; health services research tag; human subject; longitudinal human study; lung imaging /visualization /scanning; magnetic resonance imaging; outcomes research; patient care management; pulmonary circulation obstruction; relapse /recurrence; venography; venous thrombosis

The specific aim of this outcomes research project is to obtain the research training and experience necessary to become an independent investigator in clinical research. This training will include both a formal didactic component leading to a Masters of Clinical Epidemiology, and individualized mentoring by the designated sponsor. Training and hands- on experience in research study design, execution, and the responsible conduct Of research win be accomplished by implementing a prospective study to evaluate the effectiveness and safety of a strategy for the management of patients with suspected pulmonary embolism (PE) and non-diagnostic lung scans, which is practical for community hospitals, and which avoids the need for invasive testing with pulmonary angiography in most patients. The hypothesis is that in patients with clinically suspected PE, non-diagnostic lung scans, and adequate cardiorespiratory reserve, clinically important venous thromboembolism (VTE) on follow-up is rare provided that (a) the results of D-dimer and compression ultrasound (C-US) are normal at presentation or (b) if D- dimer is positive, but C-US is normal on serial testing. Those patients with non-diagnostic lung scans, and adequate cardiorespiratory reserve defined by objective, reproducible and previously validated criteria will be eligible and entered into one of three experimental cohorts: VTE negative cohort includes patients with negative C-US and D-dimer results in whom anticoagulant therapy is withheld, Serial testing cohort includes patients with positive D-dimer but negative C-US who are managed by serial C-US testing, and VTE positive cohort includes patients with positive C-US results who are treated with anticoagulant therapy. The primary outcome measure will be the incidence of new symptomatic venous thromboembolism confirmed by objective testing, during a 3 month follow-up period. The analysis will compare the incidences of VTE on follow-up between each of the VTE negative and serial testing cohorts with the VTE positive cohort. If our hypothesis is correct, clinicians will have a safe, practical approach for the management of patients with clinically suspected PE, and non-diagnostic lung scans, which can be easily applied in community hospitals or the outpatient clinic. Completion of this research will be excellent preparation for the submission of an independent Investigator Grant (R-series), and establishment of the investigator as an expert consultant in the area of venous thromboembolic disease.

该成果研究项目的具体目的是获得成为临床研究独立研究者所需的研究培训和经验。该培训将包括正式的教学部分，以获得临床流行病学硕士学位，并由指定赞助商进行个性化指导。通过实施一项前瞻性研究来评估疑似肺栓塞（PE）和非诊断性肺部扫描患者管理策略的有效性和安全性，可以完成研究设计、执行和负责任的研究的培训和实践经验，这对社区医院来说是实用的，并且避免了对大多数患者进行肺血管造影侵入性检查的需要。假设在临床疑似PE，非诊断性肺部扫描和足够的心肺储备的患者中，如果(a) D-二聚体和压缩超声（C-US）表现正常或(b) D-二聚体阳性，但C-US在系列测试中正常，则随访中临床上重要的静脉血栓栓塞（VTE）是罕见的。那些具有非诊断性肺部扫描，且具有客观、可重复和先前验证的标准定义的足够的心肺储备的患者将符合条件，并进入以下三个实验队列之一：VTE阴性队列包括C-US和d -二聚体结果阴性且不进行抗凝治疗的患者，系列检测队列包括d -二聚体阳性但C-US阴性且接受系列C-US检测的患者，VTE阳性队列包括C-US结果阳性且接受抗凝治疗的患者。主要结局指标将是在3个月的随访期间，通过客观测试确认的新症状性静脉血栓栓塞的发生率。该分析将比较VTE阴性和系列检测队列与VTE阳性队列随访时的VTE发生率。如果我们的假设是正确的，临床医生将有一种安全、实用的方法来管理临床疑似PE和非诊断性肺部扫描的患者，这种方法可以很容易地应用于社区医院或门诊。这项研究的完成将为独立研究者资助（r系列）的提交做好准备，并使研究者成为静脉血栓栓塞性疾病领域的专家顾问。