A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 18
- 主要终点
- Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock
研究概览
简要总结
Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism
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
- •Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:
- •a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP <90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan
- •Age ≥18 years
排除标准
- •Contraindications for catheter-based treatment
- •Contraindications to systemic fibrinolytic treatment or anticoagulation*
- •Active, potentially life-threatening bleeding
- •Surgery within 24h before screening
- •Cranial or spinal surgery within 14d before screening
- •Stroke within 14d before screening
- •Intracranial tumor
- •Any condition not listed here but estimated as clinically relevant as judged by the treating investigator
- •Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.
研究组 & 干预措施
conventional care
Patients in the conventional care group will receive guideline directed therapy including reperfusion treatment. If no clinically relevant hemodynamic improvement occurs, catheter-interventional treatment may be used as stated in the current ESC-guidelines
干预措施: Conventional care (Drug)
Early Catheter-Interventional Treatment + conventional care
Patients in this group will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration, if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these. Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion.
干预措施: Early Catheter-Interventional Treatment (Procedure)
Early Catheter-Interventional Treatment + conventional care
Patients in this group will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration, if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these. Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion.
干预措施: Conventional care (Drug)
结局指标
主要结局
Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock
时间窗: 7 days
1. mortality (all-cause) up to 7 days after randomization and 2. either one of the following 1. recurrent cardiac arrest or 2. persistent / recurrent shock (systolic BP \<90 mmHg or vasopressors or ECMO required to achieve a systolic BP ≥90 mmHg, in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) 24 hours after randomization
次要结局
- Mortality (all-cause)(30 days)
- All-cause mortality(7 days)
- PE-related mortality(7 days)
- Bail out therapy(7 days)
- GUSTO moderate or severe bleeding(7 days)
- VA-ECMO use(7 days)
- Change in echocardiographic parameters(24 hours)
- Days of ICU stay(30 days)
- Time to hemodynamic stabilization(30 days)