Pulmonary Embolism Subacute MassiveNCT07374978
Effect of Thrombolysis on 30-day Mortality in Intermediate High Risk Pulmonary Patients With Low Bleeding Risk
A study testing Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator and Unfractionated Heparin IV in people with Pulmonary Embolism Subacute Massive and Thrombolytic Therapy, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Pulmonary Embolism Subacute Massive, Thrombolytic Therapy
- What is being tested?
- Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator and Unfractionated Heparin IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 23Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
InvestIgators aimed to determine the effect of thrombolysis in Intermediate high risk pulmonary embolism patients with low bleeding risk as regards mortality and bleeding events.
Study design : randomized clinical study conducted Ain Shams University Hospitals over 2 years duration , included 100 participants divided into two groups; control group (50) and study group (50).
Participants assigned to the control group received standard treatment in the form of anticoagulation (intravenous unfractionated heparin) whole participant assigned to control group received thrombolytic therapy (streptokinase or recombinant tissue plasminogen activator) Investigators performed baseline echocardiography for all participants before receiving treatment and assessment of bleeding risk using HASBLED score Follow up of participants' vital data was done in a monitored care unit Participants were assessed one month later for dyspnea and its grade and follow up echocardiography was done also.
- Being tested
- Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator, Unfractionated Heparin IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activatorDrug
Thrombolytic therapy acting on thrombus in pulmonary embolism patients
Unfractionated Heparin IVDrug
Standard anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This arm will receive standard anticoagulation in the form of intravenous unfractionated heparin Receives: Drug: Unfractionated Heparin IV |
| Study group | Active comparator | This arm will receive thrombolytic therapy in the form of either streptokinase or recombinant tissue plasminogen activator Receives: Drug: Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality and bleeding events
Cardiac arrest due to pulmonary embolism (mortality) and major bleeding
Measured: 30 days for mortality and bleeding within hospital stay duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jul 2023
- Primary completion1 May 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism Subacute MassiveStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374978
- Sponsor's protocol ID
- MD129/2023
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thrombolysis on 30-day Mortality in Intermediate High Risk Pulmonary Patients With Low Bleeding Risk
- ClinicalTrials.gov ID
- NCT07374978
- Acronym / sponsor ID
- MD129/2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
InvestIgators aimed to determine the effect of thrombolysis in Intermediate high risk pulmonary embolism patients with low bleeding risk as regards mortality and bleeding events.
Study design : randomized clinical study conducted Ain Shams University Hospitals over 2 years duration , included 100 participants divided into two groups; control group (50) and study group (50).
Participants assigned to the control group received standard treatment in the form of anticoagulation (intravenous unfractionated heparin) whole participant assigned to control group received thrombolytic therapy (streptokinase or recombinant tissue plasminogen activator) Investigators performed baseline echocardiography for all participants before receiving treatment and assessment of bleeding risk using HASBLED score Follow up of participants' vital data was done in a monitored care unit Participants were assessed one month later for dyspnea and its grade and follow up echocardiography was done also.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Unfractionated Heparin IVThis arm will receive standard anticoagulation in the form of intravenous unfractionated heparin |
| Study group | Active comparator | Drug: Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activatorThis arm will receive thrombolytic therapy in the form of either streptokinase or recombinant tissue plasminogen activator |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (23 listed)
- o High risk PE
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activatorThrombolytic therapy acting on thrombus in pulmonary embolism patients | Drug | Study group |
| Unfractionated Heparin IVStandard anticoagulation | Drug | Control group |
Primary outcome
30 day mortality and bleeding events
Time frame: 30 days for mortality and bleeding within hospital stay duration
Cardiac arrest due to pulmonary embolism (mortality) and major bleeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator and Unfractionated Heparin IV in people with Pulmonary Embolism Subacute Massive and Thrombolytic Therapy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day mortality and bleeding events (time frame: 30 days for mortality and bleeding within hospital stay duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.