跳至主要内容
临床试验/NCT06246045
NCT06246045撤回不适用

The Impact of System Wide Pulmonary Embolism Screening Program on PERT Activation, Utilization of Advanced Therapies, and 90-Day Outcomes

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家目标入组 390 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
390
试验地点
2
主要终点
Time-to-activation

研究概览

简要总结

Pulmonary embolism (PE) remains a high mortality and morbidity disease state. The investigators have previously shown that use of a Pulmonary Embolism Response Team (PERT) can improve overall readmission, bleeding, and mortality outcomes. Unfortunately, PERT may still be underutilized from a national standpoint and may not be readily available in underserved areas.

The use of artificial intelligence (AI) may help streamline and systematically ensure unbiased mechanism for activation of PERT for discussion of patients with siginficant clot burden and hemodynamic abnormalities. AI algorithms have been FDA approved for use of triage of the PE patient. The institutional PERT program will adapt the use of an AI algorithm for activation as routine care; the efficiency of activation will be compared to our retrospective historical comparison for efficiency and appropriateness of activation.

The active phase of the study is designed to further differentiate between patients who are considered to be intermediate-high risk category but yet do not clearly qualify for invasive therapy (catheter-directed therapy, systemic thrombolysis, or invasive hemodynamic support). These patients will undergo walking test to further understand noninvasive hemodynamic compromise and undergo 2:1 randomization to early-invasive strategy versus mtranditional medical therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients obtaining a CT at University Hospitals found to have a pulmonary embolism with evidence of right ventricular strain (RV:LV > 0.9) along with an abnormal vital sign (HR > 110 bpm, RR > 30/min, SBP < 100 mmHg, or O2 saturation < 90%)
  • Patients undergoing PERT discussion as deemed appropriate by the provider

排除标准

  • Pregnant patients. Women of childbearing age will be asked if they are pregnant before enrollment. No formal pregnancy test will be performed as a part of this study. If a patient does require invasive intervention, as part of the routine procedure for cardiac catheterization laboratory, women of childbearing age will either undergo pregnancy testing or opt-out per their own discretion
  • Patients unable to perform 6MWT (e.g., lack of one or both legs) will not be included in the randomization. They will be included in the observation for routine treatment

结局指标

主要结局

Time-to-activation

时间窗: 3 days

Activation of PERT from time of CT scan to call; compared to historical control

次要结局

  • Length of stay(30 days)
  • Change in quality of life as measured by PEmb QoL(Baseline, 30 days, 90 days)
  • 6-minute walk test (6MWT)(6 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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