NCT02238639已完成不适用
Efficacy and Safety of an Active Strategy for the Diagnosis and Treatment of Acute Pulmonary Embolism (PE) in Patients With Unexplained Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): a Randomized Clinical Trial
Ministry of Health, Spain20 个研究点 分布在 1 个国家目标入组 746 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 746
- 试验地点
- 20
- 主要终点
- All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
研究概览
简要总结
The primary objective is to demonstrate the clinical benefits of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.
The secondary objective is to assess the safety of an active strategy for the diagnosis and treatment of PE compared to usual care in patients with unexplained exacerbations of COPD who require hospital admission.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of COPD according to SEPAR-ALT criteria: post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.7;
- •Hospital admission because COPD exacerbation without initial clinical suspicion of PE in the Emergency Department (according by the Emergency Department physician evaluation).
排除标准
- •Contraindication to multidetector computed tomographic angiography (allergy to intravenous contrast medium, or renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula)
- •Informed consent denied
- •Pregnancy
- •Life expectancy less than 3 months
- •Anticoagulant therapy at the time of hospital admission
- •Diagnosis of pneumothorax, or pneumonia (fever, and purulent sputum, and new infiltrate in chest X-ray)
- •Diagnosis of lower respiratory tract infection (fever [>37.8ºC], increased sputum volume and/or increased sputum purulence).
- •Indication of invasive mechanical ventilation at the time of hospital admission;
- •Impossibility for follow-up.
结局指标
主要结局
All-cause Mortality, Symptomatic Venous Thromboembolism Recurrence, or Need for Readmission.
时间窗: 90-day follow-up
Clinical composite endpoint of all-cause mortality, or symptomatic venous thromboembolism recurrence, or need for readmission.
次要结局
- Serious Adverse Events(90-day follow-up)
- Hospitalization(90-day follow-up)
- Major Bleeding(90-day follow-up)
- Clinically Relevant Non Major Bleeding(90-day follow-up)
- All-cause Mortality(90-day follow-up)
- Symptomatic Recurrent Venous Thromboembolism(90-day follow-up)
研究者
David Jimenez
Senior Consultant
Ministry of Health, Spain
研究点 (20)
Loading locations...
相似试验
已完成
4 期
Fibrinogen in Haemorrhage of DeliveryPost-Partum HemorrhageNCT02155725Laboratoire français de Fractionnement et de Biotechnologies448
已完成
不适用
Strategy to Recognize and Initiate Treatment of Chronic Heart FailureHeart FailureNCT01202006UMC Utrecht585
已完成
不适用
PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous ThromboembolismHematologic NeoplasmMultiple MyelomaLymphomaMyelodysplastic SyndromeAcute LeukemiaNCT01855698Gruppo Italiano Malattie EMatologiche dell'Adulto99
进行中（未招募）
不适用
Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight WearMyopiaNCT06009458Acuity Polymers, Inc.387
已完成
2 期
Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic LeukemiaIntermediate Risk Chronic Lymphocytic LeukemiaFit PatientsRisk-Adapted and MRD-Driven StrategyNCT04010968French Innovative Leukemia Organisation120