Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT06143969
Eligibility Criteria:
Inclusion Criteria
* Patients admitted with acute intermediate-high risk PE, defined according to ESC guidelines
* Symptoms onset within previous 14 days associated or not with deep venous thrombosis
* Confirmation of the PE by contrast-enhanced computed tomography of the chest with embolus located in at least one main or proximal lower lobe pulmonary artery
* Echocardiographic parameters of RV disfunction
* Patients with high-risk PE or hemodynamic deterioration on anticoagulation, who have absolute contraindications (high bleeding risk) to systemic thrombolysis and symptoms onset during the last 14 days. Patients with surgery-related embolic complications are also included (within 48 hours).
Exclusion Criteria
* Age \< 18 years old
* Patients unable to give informed consent
* Pregnancy
* Patients received fibrinolytic drugs in the preceding 4 days
* Bleeding diathesis
* Known bleeding disorder
* Low platelet count (\< 100.000/uL
* Gastrointestinal bleeding in the preceding 3 month
* Any ongoing known presence of malignant neoplasia months
* Advanced chronic kidney disease (defined as 11.000/uL)
* Gastrointestinal bleeding in the preceding 3 month
* Any ongoing known presence of malignant neoplasia at admission with survival rate \< 6
* Advanced chronic kidney disease (defined as eGFR \< 30 ml/min or on dialysis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06143969
Study Brief:
Protocol Section:
NCT06143969