An interventional study of mechanical fragmentation and In Situ thrombolysis in Pulmonary Embolism, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Venous thromboembolic disease represents one of the most important causes of cardiovascular death in the world. Symptomatic pulmonary embolism (PE) occurs in about 500,000 patients annually, with an estimated mortality as high as 30% in high-risk patients .
High-risk pulmonary embolism clinically manifests with hemodynamic instability and systemic hypotension (systolic blood pressure \< 90 mm Hg, pressure drop of more than 40 mm Hg or requiring administration of inotropic agents. In this form of PE (pulmonary embolism) imaging studies usually reveal a "saddle embolus" at the bifurcation of the pulmonary trunk, embolism of the main pulmonary artery, or embolic occlusion of at least two lobar arteries.
Mortality in high-risk pulmonary embolism is at the level of 60%, and in 66% of these patients fatal outcomes take place during the first hours from the onset of clinical symptoms. The remaining patients with severe pulmonary embolism , those with intermediate risk of mortality, do not reveal hypotension, but present with clinical symptoms comprising dyspnea and/or tachycardia. Estimated 30-day mortality in patients with intermediate risk PE (pulmonary embolism) is at the level of 15-20%, and these patients are at a risk of developing pulmonary hypertension and right ventricle heart failure. Given the fact that 40% of patients with class 4 or 5 of the Pulmonary Embolism Severity Index present with contraindications for systemic fibrinolytic therapy, Catheter-directed reperfusion therapy seems to be a promising alternative treatment modality.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
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Exclusion Criteria:
patients without any contraindications for systemic fibrinolytic therapy will be treated with traditional systemic thrombolysis (intravenous administration of streptokinase).
patients will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy.
Procedure: mechanical fragmentation
patients will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC(Swan-Ganz pulmonary artery catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women).
Procedure: In Situ thrombolysis
patients who will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy
Group (C) will include the patients who will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC (Swan-Ganz catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women).
Rate of mortality (mortality rate)
number of deaths from total number of patients in each arm
Time frame: 30-day
Rate of complications
as major and minor bleedings
Time frame: 7 days
Rate of Success
number of cases with clinical success which defined as stabilization of hemodynamic parameters, resolution of hypoxia, survival from PE(pulmonary embolism) and restoring of right ventricular function (improvement of ghit ventricle and pulmonary artery pressure and decrease troponin level)
Time frame: 2 weeks
Percent of Changes in mean blood pressure
the percent of change in mean arterial blood pressure
Time frame: Baseline (measured at first admission) and compared with measurements the following second, eighth, and 24th hours of the intervention.
Mean pulmonary artery pressure
Mean pulmonary artery pressure will be estimated by transthoracic echocardiography
Time frame: Baseline (at addmission) and 24 hours after catheter-directed intervention
Duration of ICU(intensive care unit) stay
the duration of ICU (intensive care unit) stay by days
Time frame: "through study completion, an average of 1 year".
Duration of hospital stay
the duration of hospital stay by days
Time frame: "through study completion, an average of 1 year".
No study locations are listed for this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Assiut University