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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT04088292
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Informed consent for trial participation
3. Intermediate high-risk PE according to ESC criteria
4. Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
5. 14 days of symptoms or less
Exclusion Criteria:
1. Altered mental state (GCS \< 14)
2. No qualifying CT angiography performed (\> 24 hour since CT angiography)
3. Females of child bearing potential, unless negative HCG test is present
4. Thrombolysis for PE within 14 days of randomization
5. Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
6. Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
7. Comorbidity making 6 months survival unlikely
8. Absolute contraindications for thrombolysis
1. Hemorrhagic stroke or stroke of unknown origin at any time
2. Ischemic stroke in the preceding 6 months
3. Central nervous system damage or neoplasms
4. Recent major trauma/surgery/head injury in the preceding 3 weeks
5. Gastrointestinal bleeding within the last month
6. Known bleeding risk
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04088292
Study Brief:
Protocol Section:
NCT04088292