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

ConditionAcute Pulmonary Embolism
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial population

All patients will be subjected to: On admission: Detailed history for assessment of risk factors Clinical examination: Laboratory investigations. Trans-thoracic echocardiography to detect signs of PE: MSCT pulmonary angiography: for assessment of site, size and shape of pulmonary embolism. PESI and sPESI scores will be calculated for all patients. In hospital follow up: During hospital stay all patients will be followed up daily for assessment of hemodynamic, oxygen saturation, TTE, troponin level, need of mechanical ventilation or death. One month follow up after discharge: for the assessment of: Hemodynamic. Transthoracic echocardiography. MSCT pulmonary angiography.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Streptokinase Injection

    Drug

    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

    Device

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: patients who received systemic thrombolysis1 intervention
Group B: patients who underwent catheter-based intervention1 intervention

Trial outcomes

Primary outcomes

1

Change in blood pressure

Time frame
during hospital stay (about 1 week) and one month after discharge
2

Change in heart rate

Time frame
during hospital stay (about 1 week) and one month after discharge
3

Change in respiratory rate

Time frame
during hospital stay (about 1 week) and one month after discharge
4

Change of O2 saturation.

Time frame
during hospital stay (about 1 week)

Secondary outcomes

1

incidence of Perforation of pulmonary artery

may occur during catheter directed interventions

Time frame
during hospital stay (about 1 week)
2

incidence of pericardial effusion

due to: infection cardiac perforation during catheter directed interventions

Time frame
during hospital stay (about 1 week) and one month after discharge
3

incidence of Major bleeding

that requires blood transfusions or urgent intervention

Time frame
during hospital stay (about 1 week) and one month after discharge

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: