2024-511959-18-01招募中3 期
Registry-based randomized trial to determine the role of Oxygen in acute Pulmonary Embolism
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal36 个研究点 分布在 1 个国家目标入组 3,900 人开始时间: 2024年5月27日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 3,900
- 试验地点
- 36
- 主要终点
- Composite of hemodynamic collapse or death from any cause within 30 days after enrollment.
研究概览
简要总结
To evaluate the efficacy of supplemental oxygen in patients with intermediate-risk acute pulmonary embolism at day 30.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Pulmonary embolism confirmed by multidetector computed tomographic pulmonary angiography
- •Right ventricular enlargement confirmed by computed tomography (transverse view) or echocardiography (apical or subcostal four chamber) where the right ventricle/left ventricle ratio is >1.0
排除标准
- •Age less than 18 years
- •Participating in any other investigational drug or device study
- •Life expectancy <90 days at the discretion of the enrolling clinician
- •Oxygen saturation of less than 90% on pulse oximetry at the time of diagnosis
- •Technically inadequate basal computed tomography or echocardiography that prohibits the measurement of the right and left ventricle dimensions
- •Use of chronic oxygen therapy
- •Known hypercapnia (pCO2 >50 mmHg on arterial blood gases) at the time of diagnosis
- •Contraindication to anticoagulant therapy according to the physician judgement
- •Time elapsed since index diagnosis of pulmonary embolism symptom >10 days
- •Hemodynamic collapse at the time of PE diagnosis, defined as: need for cardiopulmonary resuscitation; or systolic blood pressure <90 mmHg for at least 15 min, or drop of systolic blood pressure by at least 40 mmHg for at least 15 min with signs of end organ hypoperfusion (cold extremities or low urinary output <30 mL/h or mental confusion); or need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of >90 mmHg
- •Inability to use mask or nasal prongs
结局指标
主要结局
Composite of hemodynamic collapse or death from any cause within 30 days after enrollment.
Composite of hemodynamic collapse or death from any cause within 30 days after enrollment.
次要结局
- Death from any cause within 30 days after enrollment
- Hemodynamic collapse within 30 days after enrollment
- Pulmonary embolism-related mortality within 30 days after enrollment
- Length of hospital stay
- Death from any cause within 90 days after enrollment
- Serious adverse events within 30 days after enrollment
- Major bleeding within 30 days after enrollment
- Recurrent symptomatic venous thromboembolism within 30 days after enrollment
研究者
Mayra
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
研究点 (36)
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