Acute Pulmonary EmbolismNCT06545864
Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism
An observational study of Acute Pulmonary Embolism, run by Assiut University at 1 site in Egypt.
Trial summary
To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- Streptokinase Injection and Penumbra System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Mar 2030
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients will be subjected to: On admission: Detailed history for assessment of risk factors Clinical examination: Laboratory investigations. Trans-thoracic echocardiography to detect signs of PE: MSCT pulmonary angiography: for assessment of site, size and shape of pulmonary embolism. PESI and sPESI scores will be calculated for all patients. In hospital follow up: During hospital stay all patients will be followed up daily for assessment of hemodynamic, oxygen saturation, TTE, troponin level, need of mechanical ventilation or death. One month follow up after discharge: for the assessment of: Hemodynamic. Transthoracic echocardiography. MSCT pulmonary angiography.
Who may be able to join
- Patients diagnosed with acute intermediate-high pulmonary embolism
Who cannot join
- Patients less than 18 years of age.
- Low risk, intermediate low risk, acute pulmonary embolism
- patients with RV masses will be excluded.
- Patient refusal of treatment strategy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Hospital University
Asyut
Mohamed O Abdelhameed, master, 01061878040, mosman87@gmail.com
About this study
Official title: In Hospital Clinical Outcomes and Short Term Follow up of Systemic Thrombolysis Versus Catheter Directed Management for the Treatment of Acute Intermediate-high Pulmonary Embolism
To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).
- Conditions
- Acute Pulmonary Embolism
- Being tested
- Streptokinase Injection, Penumbra System
- Keywords
- intermediate-high, acute pulmonary embolism, systemic thrombolysis, catheter- directed management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streptokinase InjectionDrug
Also called Kabikinase, Streptase
250000 IU as a loading dose over 30 min. Followed by 100000 IU/hour over 12:24hours or accelerated regimen 1.5 million IU over 2 hours
Penumbra SystemDevice
which comprised of several devices:
- RED Reperfusion Catheters
- Penumbra JET Reperfusion Catheters
- ACE Reperfusion Catheters
- MAX Reperfusion Catheters
- 3D Revascularization Device
- Penumbra ENGINE Aspiration Source
- Penumbra ENGINE Canister
- Aspiration Tubing
| Study group | Role | What they receive |
|---|---|---|
| patients who received systemic thrombolysis | patients have been diagnosed with acute intermediate-high pulmonary embolism received I.V. streptokinase if there are no contraindications. Receives: Drug: Streptokinase Injection | |
| patients who underwent catheter-based intervention | patients have been diagnosed with acute intermediate-high pulmonary embolism underwent catheter-based intervention including thrombus aspiration or catheter directed thrombolysis using Penumbra System Receives: Device: Penumbra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: during hospital stay (about 1 week) and one month after discharge
Change in heart rate
Measured: during hospital stay (about 1 week) and one month after discharge
Change in respiratory rate
Measured: during hospital stay (about 1 week) and one month after discharge
Change of O2 saturation.
Measured: during hospital stay (about 1 week)
Change of RV signs of PE by Transthoracic echocardiography
Measured: during hospital stay (about 1 week) and one month after discharge
Need for mechanical ventilation.
Measured: during hospital stay (about 1 week)
Need for surgical intervention.
surgical embolectomy
Measured: during hospital stay (about 1 week)
Duration of hospital stay.
Measured: during hospital stay (about 1 week)
Secondary outcomes (3)
incidence of Perforation of pulmonary artery
may occur during catheter directed interventions
Measured: during hospital stay (about 1 week)
incidence of pericardial effusion
due to: infection cardiac perforation during catheter directed interventions
Measured: during hospital stay (about 1 week) and one month after discharge
incidence of Major bleeding
that requires blood transfusions or urgent intervention
Measured: during hospital stay (about 1 week) and one month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam J William, Assiut University
- Investigators
- Ayman K Mohamed, PHD, Principal investigator, Assiut UniversityMohamed O Abdelhameed, master, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545864
- Sponsor's protocol ID
- 123456@qerty
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Hospital Clinical Outcomes and Short Term Follow up of Systemic Thrombolysis Versus Catheter Directed Management for the Treatment of Acute Intermediate-high Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06545864
- Acronym / sponsor ID
- 123456@qerty
- Conditions
- Acute Pulmonary Embolism
- Keywords
- intermediate-high, acute pulmonary embolism, systemic thrombolysis, catheter- directed management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 9 Aug 2024 (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.
To compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who received systemic thrombolysis | – | Drug: Streptokinase Injectionpatients have been diagnosed with acute intermediate-high pulmonary embolism received I.V. streptokinase if there are no contraindications. |
| patients who underwent catheter-based intervention | – | Device: Penumbra Systempatients have been diagnosed with acute intermediate-high pulmonary embolism underwent catheter-based intervention including thrombus aspiration or catheter directed thrombolysis using Penumbra System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be subjected to: On admission: Detailed history for assessment of risk factors Clinical examination: Laboratory investigations. Trans-thoracic echocardiography to detect signs of PE: MSCT pulmonary angiography: for assessment of site, size and shape of pulmonary embolism. PESI and sPESI scores will be calculated for all patients. In hospital follow up: During hospital stay all patients will be followed up daily for assessment of hemodynamic, oxygen saturation, TTE, troponin level, need of mechanical ventilation or death. One month follow up after discharge: for the assessment of: Hemodynamic. Transthoracic echocardiography. MSCT pulmonary angiography.
Key inclusion criteria (1 listed)
- Patients diagnosed with acute intermediate-high pulmonary embolism
Key exclusion criteria (4 listed)
- Patients less than 18 years of age.
- Low risk, intermediate low risk, acute pulmonary embolism
- patients with RV masses will be excluded.
- Patient refusal of treatment strategy.
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 |
|---|---|---|
| Streptokinase InjectionAlso: Kabikinase, Streptase250000 IU as a loading dose over 30 min. Followed by 100000 IU/hour over 12:24hours or accelerated regimen 1.5 million IU over 2 hours | Drug | patients who received systemic thrombolysis |
| Penumbra Systemwhich comprised of several devices: * RED Reperfusion Catheters * Penumbra JET Reperfusion Catheters * ACE Reperfusion Catheters * MAX Reperfusion Catheters * 3D Revascularization Device * Penumbra ENGINE Aspiration Source * Penumbra ENGINE Canister * Aspiration Tubing | Device | patients who underwent catheter-based intervention |
Primary outcome
Change in blood pressure
Time frame: during hospital stay (about 1 week) and one month after discharge
Change in heart rate
Time frame: during hospital stay (about 1 week) and one month after discharge
Change in respiratory rate
Time frame: during hospital stay (about 1 week) and one month after discharge
Change of O2 saturation.
Time frame: during hospital stay (about 1 week)
Change of RV signs of PE by Transthoracic echocardiography
Time frame: during hospital stay (about 1 week) and one month after discharge
Need for mechanical ventilation.
Time frame: during hospital stay (about 1 week)
Need for surgical intervention.
Time frame: during hospital stay (about 1 week)
surgical embolectomy
Duration of hospital stay.
Time frame: during hospital stay (about 1 week)
3 secondary outcomes
incidence of Perforation of pulmonary artery
Time frame: during hospital stay (about 1 week)
incidence of pericardial effusion
Time frame: during hospital stay (about 1 week) and one month after discharge
incidence of Major bleeding
Time frame: during hospital stay (about 1 week) and one month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. compare in hospital clinical outcomes and one month follow up of systemic thrombolysis versus catheter directed management for the treatment of acute intermediate- high risk pulmonary embolism (using streptokinase or tissue plasminogen activator (TPA) and catheter-based intervention group using Penumbra System).
Related trials for Acute Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Not yet recruitingPhase 3
Reduced-Dose Thrombolysis in Intermediate-Risk Pulmonary Embolism With High-Risk Features
Pulmonary Embolism
Not yet recruiting
Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Acute Pulmonary Embolism
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
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.
Ayman K Mohamed, PHD principal investigator
Assiut University
Mohamed O Abdelhameed, master study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pulmonary Embolism, run by Assiut 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 4 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: opening soon, as of the sponsor's last update on 9 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mariam J william (01009083119, mariamjoseph1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: during hospital stay (about 1 week) and one month after discharge). The study lists 8 primary outcomes in all. 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 9 Aug 2024.