Clinical trial NCT06545864: Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Pulmonary Embolism
Keywords: intermediate-high
acute pulmonary embolism
systemic thrombolysis
catheter- directed management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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 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.

Primary outcomes:
measure: Change in blood pressure
timeFrame: during hospital stay (about 1 week) and one month after discharge
measure: Change in heart rate
timeFrame: during hospital stay (about 1 week) and one month after discharge
measure: Change in respiratory rate
timeFrame: during hospital stay (about 1 week) and one month after discharge
measure: Change of O2 saturation.
timeFrame: during hospital stay (about 1 week)
measure: Change of RV signs of PE by Transthoracic echocardiography
timeFrame: during hospital stay (about 1 week) and one month after discharge
measure: Need for mechanical ventilation.
timeFrame: during hospital stay (about 1 week)
measure: Need for surgical intervention.
timeFrame: during hospital stay (about 1 week)
measure: Duration of hospital stay.
timeFrame: during hospital stay (about 1 week)
Secondary outcomes:
measure: incidence of Perforation of pulmonary artery
timeFrame: during hospital stay (about 1 week)
measure: incidence of pericardial effusion
timeFrame: during hospital stay (about 1 week) and one month after discharge
measure: incidence of Major bleeding
timeFrame: during hospital stay (about 1 week) and one month after discharge
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Hospital University
Study officials:
affiliation: Assiut University
name: Ayman K Mohamed, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Mohamed O Abdelhameed, master
role: STUDY_DIRECTOR
References: