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NCT07885787
Post Pulmonary Embolism In Patients Treated With Catheter Based Therapy
Conditions: Pulmonary Embolism Acute
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Assiut University
Location: Assiut university heart hospital Asyut
Summary
Comparing the effects of the mechanical thrombectomy versus medical treatment alone on development and severity of post pulmonary embolism syndrome.
To define predictors of post pulmonary embolism syndrome. Incidence of category D and category E pulmonary embolism among P.E patients presenting by hemodynamic compromise.
Correlation with NEWS risk score (Respiratory rate, oxygen saturation, temperature, systolic blood pressure, heart rate, level of consciousness, and need for supplemental oxygen).
Eligibility Criteria
Inclusion Criteria:
* Age 18-80 years old.
* Clinical signs and symptoms consistent with acute PE with duration of 14 days or less.
* Objectively confirmed acute PE, based on CTPA imaging showing a filling defect in at least one main or proximal lobar pulmonary artery.
* Category E patients according to AHA recent guidelines for management of P.E including patients with cardiopulmonary failure states (either cardiac arrest, refractory cardiogenic shock or recurrent or persistent hypotension with cardiogenic shock).
* Category D patients (i.e patients with incipient cardiopulmonary failure) including normotensive shock with marker of decreased perfusion or end-organ dysfunction (eg, acute ischemic kidney injury, persistently elevated lactate) accompanied by transient hypotension and patients with transient or recurrent hypotension (including relative hypotension compared with the patient's baseline blood pressure) that is short-lived or responds to volume expansion and not accompanied by any signs of reduced perfusion or end-organ dysfunction.
* Category C2,C3 patients with symptomatic disease with increased risk of adverse outcomes by validated severity index and either abnormal RV or abnormal cardiac biomarkers or both.
* Femoral access deemed suitable for mechanical thrombectomy.
* Informed consent is obtained from either the patient or legally authorized representative.
Exclusion Criteria:
* Category A patients including asymptomatic and incidentally diagnosed PE cases.
* Category B patients with symptomatic acute PE and low risk of adverse outcomes by validated severity indices.
* Category C1 patients with symptomatic disease with increased risk of adverse outcomes by validated severity index with normal RV and normal cardiac biomarkers.
* History or imaging findings consistent with CTEPH or CTEPD diagnosis.
* Any known contraindication to anticoagulation including allergy, hypersensitivity, or heparin induced thrombocytopenia.
* Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated.
* Active bleeding or disorders contraindicating anticoagulant therapy.
* Platelets \
Source: ClinicalTrials.gov (NCT07885787). StuddyBuddy aggregates publicly available trial information.