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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT00799968
Eligibility Criteria:
Inclusion Criteria:
* PTE confirmed either by a high probability ventilation-perfusion lung scanning (V/Q scan) or by CTPA.
* massive PTE patients with haemodynamic instability and/or cardiogenic shock
* Anatomic obstruction more than 2 lobes on CTPA and/or defect more than 7 segments on V/Q scan with evidence of right ventricular dysfunction (RVD) and pulmonary hypertension on echocardiography
* Symptoms within 15 days
* Written informed consent was obtained from all the patients before randomization
Exclusion Criteria:
* Received parenteral heparin for more than 72 hours
* Known allergic to urokinase
* Thrombolytic contraindications such as:
1. active bleeding or spontaneous intracranial hemorrhage;
2. major surgery, organ biopsy or recent puncture of a non-compressible vessel less than 10 days;
3. cerebral arterial thrombosis within 2 months;
4. gastro-intestinal bleeding within 10 days;
5. major trauma within the past 15 days;
6. neurosurgery or ophthalmologic operation with 30 days;
7. uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg);
8. recent external cardiac resuscitation manoeuvres;
9. platelet count \< 100 000/mm3 at admission;
10. pregnancy, puerperium or lactation with 2 weeks;
11. infectious pericarditis or endocarditis;
12. severe hepatic and kidney dysfunction;
13. hemorrhagic retinopathy due to diabetes;
14. a known bleeding disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00799968
Study Brief:
Protocol Section:
NCT00799968