Evaluation of Safety and Efficacy of Hydro-mechanical Defragmentation of High Risk Pulmonary Embolism With Contraindications to Thrombolytic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 30-day mortality
研究概览
简要总结
Evaluating the safety and outcomes of hydro-mechanical defragmentation of high risk pulmonary embolism with contraindication for thrombolytic therapy
详细描述
In high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk.
The first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. However a significant proportion of patients may not be a candidate for Intravenous thrombolysis because of major contraindications. An alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited.
Percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by injection of 200 ml saline at high pressure using power injector can be used as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
inclusion in each arm was made by pulmonary embolism response team not by the investigators . also at level of follow up assessment was done by blinded investigators.
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 with angiographically confirmed acute high risk pulmonary embolism with shock index >
- •Pulmonary arterial occlusion with >50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure >25 mmHg)
- •Patients with high risk pulmonary embolism who cannot receive fibrinolysis
- •Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis)
排除标准
- •Patients with echocardiographically confirmed right sided thrombi.
- •Patients with low-risk pulmonary embolism or intermediate-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
- •Anaphylactic reaction to contrast media.
- •Acute renal failure or severe chronic non-dialysis dependent kidney disease.
- •Uncooperative patient
结局指标
主要结局
30-day mortality
时间窗: 30 days
measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis
次要结局
- oxygen saturation(24 hours)
- Changes in blood pressure(24 hours)
研究者
Ayman khairy Mohamed
assisstant professor
Assiut University