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Clinical Trials in Egypt / NCT06545864
Starting soon Observational

Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism

NCT06545864 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Observational
Started
2024-10-01
Last updated
2024-08-09

Condition(s) studied

Acute Pulmonary Embolism

Investigational drug(s) / intervention(s)

Streptokinase InjectionPenumbra System

Streptokinase Injection: 250000 IU as a loading dose over 30 min. Followed by 100000 IU/hour over 12:24hours or accelerated regimen 1.5 million IU over 2 hours

Penumbra System: which comprised of several devices: * RED Reperfusion Catheters * Penumbra JET Reperfusion Catheters * ACE Reperfusion Catheters * MAX Reperfusion Catheters * 3D Revascularization Device * Penumbra ENGINE Aspiration Source * Penumbra ENGINE Canister * Aspiration Tubing

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients diagnosed with acute intermediate-high pulmonary embolism Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Change in blood pressure — during hospital stay (about 1 week) and one month after discharge
  • Change in heart rate — during hospital stay (about 1 week) and one month after discharge
  • Change in respiratory rate — during hospital stay (about 1 week) and one month after discharge
  • Change of O2 saturation. — during hospital stay (about 1 week)
  • Change of RV signs of PE by Transthoracic echocardiography — during hospital stay (about 1 week) and one month after discharge
  • Need for mechanical ventilation. — during hospital stay (about 1 week)
  • Need for surgical intervention. — during hospital stay (about 1 week)
    surgical embolectomy
  • Duration of hospital stay. — during hospital stay (about 1 week)

Trial sites (1)

FacilityCityRegionStatus
Hospital University Asyut Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06545864 on ClinicalTrials.gov ↗ ← All trials in Egypt