In Hospital Clinical Outcomes and Short Term Follow up of Systemic Thrombolysis Versus Catheter Directed Management for the Treatment of Acute Intermediate-high Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients diagnosed with acute intermediate-high pulmonary embolism
排除标准
- •Patients less than 18 years of age.
- •Low risk, intermediate low risk, acute pulmonary embolism
- •patients with RV masses will be excluded.
- •Patient refusal of treatment strategy.
研究组 & 干预措施
patients who received systemic thrombolysis
patients have been diagnosed with acute intermediate-high pulmonary embolism received I.V. streptokinase if there are no contraindications.
干预措施: Streptokinase Injection (Drug)
patients who underwent catheter-based intervention
patients have been diagnosed with acute intermediate-high pulmonary embolism underwent catheter-based intervention including thrombus aspiration or catheter directed thrombolysis using Penumbra System
干预措施: Penumbra System (Device)
结局指标
主要结局
Change in blood pressure
时间窗: during hospital stay (about 1 week) and one month after discharge
Change in respiratory rate
时间窗: during hospital stay (about 1 week) and one month after discharge
Change of O2 saturation.
时间窗: during hospital stay (about 1 week)
Need for mechanical ventilation.
时间窗: during hospital stay (about 1 week)
Change in heart rate
时间窗: during hospital stay (about 1 week) and one month after discharge
Change of RV signs of PE by Transthoracic echocardiography
时间窗: during hospital stay (about 1 week) and one month after discharge
Need for surgical intervention.
时间窗: during hospital stay (about 1 week)
surgical embolectomy
Duration of hospital stay.
时间窗: during hospital stay (about 1 week)
次要结局
- incidence of Perforation of pulmonary artery(during hospital stay (about 1 week))
- incidence of pericardial effusion(during hospital stay (about 1 week) and one month after discharge)
- incidence of Major bleeding(during hospital stay (about 1 week) and one month after discharge)
研究者
Mariam J William
Principal Investigator
Assiut University