Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Streptokinase Injection, Penumbra System.
- Who it may be relevant to
- Registry conditions: Acute Pulmonary Embolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Interventions
- Drug 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 - Device 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
Primary outcome measures
- Change in blood pressure [Time frame: during hospital stay (about 1 week) and one month after discharge]
- Change in heart rate [Time frame: during hospital stay (about 1 week) and one month after discharge]
- Change in respiratory rate [Time frame: during hospital stay (about 1 week) and one month after discharge]
- Change of O2 saturation. [Time frame: during hospital stay (about 1 week)]
- Change of RV signs of PE by Transthoracic echocardiography [Time frame: during hospital stay (about 1 week) and one month after discharge]
- Need for mechanical ventilation. [Time frame: during hospital stay (about 1 week)]
- Need for surgical intervention. [Time frame: during hospital stay (about 1 week)]
- Duration of hospital stay. [Time frame: during hospital stay (about 1 week)]
Secondary outcome measures (3)
- incidence of Perforation of pulmonary artery [Time frame: during hospital stay (about 1 week)]
- incidence of pericardial effusion [Time frame: during hospital stay (about 1 week) and one month after discharge]
- incidence of Major bleeding [Time frame: during hospital stay (about 1 week) and one month after discharge]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Egypt · 1 center
- Hospital University — Asyut
Identifiers
NCT: NCT06545864 · 123456@qerty