Effect of Thrombolysis on 30-day Mortality in Intermediate High Risk Pulmonary Patients With Low … (NCT07374978) | Clinical Trial Compass
CompletedNot Applicable
Effect of Thrombolysis on 30-day Mortality in Intermediate High Risk Pulmonary Patients With Low Bleeding Risk
Egypt100 participantsStarted 2023-07-01
Plain-language summary
The aim of investigators was to study the effect and safety of Thrombolysis in Intermediate high risk pulmonary embolism patients with low bleeding risk as regards Mortality and bleeding events.
Who can participate
Age range
25 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with intermediate high risk pulmonary embolism diagnosed according to clinical probability using revised Geneva Score and diagnosis confirmed by echocardiography and Troponin I or T level and CT pulmonary angiography
Exclusion Criteria:
* o High risk PE
* Intermediate low risk PE
* low risk PE
* Patients with left ventricular systolic dysfunction (ischemic or non-ischemic etiology)
* Patients with chronic lung diseases (obstructive or restrictive)
* Patients with contraindications to thrombolysis:
* History of haemorrhagic stroke or stroke of unknown origin
* Ischaemic stroke in previous 6 months
* Central nervous system neoplasm
* Major trauma, surgery, or head injury in previous 3 weeks
* Bleeding diathesis (known inherited bleeding disorder, for example, haemophilia, platelet count \<50,000/uL)
* Active bleeding
* Transient ischaemic attack in previous 6 months
* Oral anticoagulation
* Pregnancy or first post-partum week
* Non-compressible puncture sites
* Traumatic resuscitation
* Severe hypertension (systolic BP \>180 mmHg)
* Advanced liver disease
* Infective endocarditis
* Active Peptic ulcer
* Patients who develop hypotension or bradycardia or allergic reaction requiring discontinuation of Streptokinase infusion.
* Patients with HAS-BLED score greater than or equals 3 (high bleeding risk for thrombolysis)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
30 day mortality and bleeding events
Timeframe: 30 days for mortality and bleeding within hospital stay duration