Status:
UNKNOWN
Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism
Lead Sponsor:
Poznan University of Medical Sciences
Conditions:
Pulmonary Embolism With Acute Cor Pulmonale
Eligibility:
All Genders
18+ years
Brief Summary
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmona...
Detailed Description
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmona...
Eligibility Criteria
Inclusion
- Clinical symptoms and presentation consistent with pulmonary embolism (PE).
- PE symptoms duration ≤ 14 days.
- High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours:
- Systolic blood pressure \> 90 mmHg and ≤ 100 mmHg
- Heart rate ≥ 110/min,
- Arterial blood saturation \<90% during spontaneous breathing (atm)
- Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed factors:
- Systolic blood pressure \> 90 mmHg and ≤ 100 mmHg
- Heart rate≥ 110/min,
- Arterial blood saturation \<90% during spontaneous breathing (atm)
Exclusion
- Pregnancy.
- Refusal to sign the informed consent form.
- Presence of intracardiac thrombus.
- Diagnosed thrombophilia.
- Severe thrombocytopenia (platelets count below 20 000 µL).
- History of severe or chronic pulmonary hypertension.
- Serum creatinine level higher than 1.8 mg/dl.
- Known serious and uncontrolled sensitivity to radiographic agents.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04473560
Start Date
October 1 2018
End Date
December 31 2022
Last Update
August 18 2020
Active Locations (1)
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1
Poznan University of Medical Sciences
Poznan, Greaterpoland, Poland, 61-701