NCT03595085

Catheter Directed Interventions in Pulmonary Embolism

Safety and Efficacy of Catheter Directed Interventions in Acute High Risk Pulmonary Embolism

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Evaluating the safety and outcomes of catheter directed thrombolysis following catheter fragmentation in acute high risk pulmonary embolism

Detailed description

Acute pulmonary embolism is common, but its presentation highly varies ranging from asymptomatic to massive pulmonary embolism. Massive pulmonary embolism is a common life-threatening condition and represents the most serious manifestation among venous thromboembolic disease. Acute pulmonary embolism is considered the third most common cause of death among hospitalized patients . The mortality rate can exceed 58% in patients with acute pulmonary embolism presenting with haemodynamic instability , mostly occur within 1 hour of presentation. In patients with 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 local thrombolytic therapy is accepted as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow. Several reports have shown that catheter-directed therapy is a safe and effective treatment for acute PE to restore pulmonary flow and decreasing Pulmonary artery systolic pressure , However, current knowledge on efficacy and safety of catheter-directed therapy in management of intermediate high risk pulmonary embolism is limited.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
PROCEDURE	catheter directed fragmentation and thrombolysis	A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery. After ensuring initial flow, Initial bolus dose of streptokinase (250.000 international unit) will be given over 10 min followed by continuous infusion of (100.000 international unit per hour)for 24 hours
DRUG	Streptokinase	intravenous streptokinase at a dose of 250 000 international unit as a loading dose over 30 minutes, followed by 100 000 international unit per hour over 12-24 hours

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-10-01
• Completion: 2021-03-01
• First posted: 2018-07-23
• Last updated: 2018-07-24