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:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT04688320
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 and over
* Verified diagnosis of massive PE (using MSCT with PA contrast)
* Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
* Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
* women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
* men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility)
* Availability of signed and dated informed consent of the patient to participate in the study.
Exclusion Criteria:
* • Increased risk of bleeding:
* Extensive bleeding at present or within the previous 6 months, hemorrhagic diathesis;
* Intracranial (including subarachnoid) hemorrhage at present or in history, suspected hemorrhagic stroke;
* A history of hemorrhagic stroke or stroke of unknown etiology;
* Ischemic stroke or transient ischemic attack within the last 6 months, except for the current acute ischemic stroke within 4.5 hours;
* A history of diseases of the central nervous system (including neoplasms, aneurysms, surgery on the brain or spinal cord);
* Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;
* Long-term or traumatic cardiopulmonary resuscitation (\> 2 min), delivery within the previous 10 days, recent puncture of an uncompressible blood vessel (eg, subclavian or jugular vein);
* Severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;
* Confirmed gastric or duodenal ulcer within the last three months;
* Neoplasm with an increased risk of bleeding;
* Concurrent administration of oral anticoagulants, for example, warfarin with an INR\> 1.3;
* Arterial aneurysms, developmental defects of arteries / veins;
* Severe uncontrolled arterial hypertension;
* Acute pancreatitis;
* Bacterial endocarditis, pericarditis;
* suspicion of aortic dissecting aneurysm;
* any other conditions, in the opinion of the doctor, associated with a high risk of bleeding.
* Lactation, pregnancy
* Known hypersensitivity to Alteplase, Fortelizin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04688320
Study Brief:
Protocol Section:
NCT04688320