Pulmonary EmbolismNCT03595085
Catheter Directed Interventions in Pulmonary Embolism
A study testing catheter directed fragmentation and thrombolysis and Streptokinase in people with Pulmonary Embolism, run by Assiut University.
Trial summary
Evaluating the safety and outcomes of catheter directed thrombolysis following catheter fragmentation in acute high risk pulmonary embolism Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- catheter directed fragmentation and thrombolysis and Streptokinase
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with angiographically confirmed acute high risk pulmonary embolism with shock index >1.
- Pulmonary arterial occlusion with >50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure >25 mmHg)
- Patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis
- Patients with high risk pulmonary embolism who cannot receive fibrinolysis
- Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV dysfunction, or major myocardial necrosis)
Who cannot join
- Patients with echocardiographically confirmed right sided thrombi.
- Patients with low-risk pulmonary embolism or intermediater-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
- Acute gastrointestinal bleeding.
- Anticoagulation with international normalized ratio >1.8 or severe coagulopathy.
- Anaphylactic reaction to contrast media.
- Acute stroke.
- Acute renal failure or severe chronic non-dialysis dependent kidney disease.
- Uncooperative patient
About this study
Official title: Safety and Efficacy of Catheter Directed Interventions in Acute High Risk Pulmonary Embolism
Evaluating the safety and outcomes of catheter directed thrombolysis following catheter fragmentation in acute high risk pulmonary embolism
Read the detailed description
Acute pulmonary embolism is common, but its presentation highly varies ranging from asymptomatic to massive pulmonary embolism. Massive pulmonary embolism is a common life-threatening condition and represents the most serious manifestation among venous thromboembolic disease.
Acute pulmonary embolism is considered the third most common cause of death among hospitalized patients . The mortality rate can exceed 58% in patients with acute pulmonary embolism presenting with haemodynamic instability , mostly occur within 1 hour of presentation.
In patients with high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk.
The first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. However a significant proportion of patients may not be a candidate for Intravenous thrombolysis because of major contraindications. An alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited.
Percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by local thrombolytic therapy is accepted as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow. Several reports have shown that catheter-directed therapy is a safe and effective treatment for acute PE to restore pulmonary flow and decreasing Pulmonary artery systolic pressure , However, current knowledge on efficacy and safety of catheter-directed therapy in management of intermediate high risk pulmonary embolism is limited.
- Conditions
- Pulmonary Embolism
- Being tested
- catheter directed fragmentation and thrombolysis, Streptokinase
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter directed fragmentation and thrombolysisProcedure or surgery
A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery. After ensuring initial flow, Initial bolus dose of streptokinase (250.000 international unit) will be given over 10 min followed by continuous infusion of (100.000 international unit per hour)for 24 hours
StreptokinaseDrug
intravenous streptokinase at a dose of 250 000 international unit as a loading dose over 30 minutes, followed by 100 000 international unit per hour over 12-24 hours
| Study group | Role | What they receive |
|---|---|---|
| catheter directed interventions | Experimental | Those patients will undergo catheter directed fragmentation followed by local thrombolysis using streptokinase Receives: Procedure: catheter directed fragmentation and thrombolysis |
| systemic thrombolysis | Active comparator | Those patients will receive systemic streptokinase Receives: Drug: Streptokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis
Measured: 30 days
Secondary outcomes (3)
Changes in blood pressure
systolic and diastolic blood pressure will be measured at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
Measured: 24 hours
oxygen saturation
oxygen saturation will be measured by arterial blood gases analysis at first admission and compared with measurements the following second, eighth, and 24th hours of the intervention
Measured: 24 hours
changes in right ventricular dysfunction
right ventricular dysfunction will be assessed by echocardiography and Mean pulmonary artery systolic pressure will be estimated by transthoracic echocardiography at first admission and 24 hours after catheter-directed intervention
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595085
- Sponsor's protocol ID
- CTPE
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available.
PubMed 18296591Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.
PubMed 25173341Uflacker R. Interventional therapy for pulmonary embolism. J Vasc Interv Radiol. 2001 Feb;12(2):147-64. doi: 10.1016/s1051-0443(07)61821-1.
PubMed 11265879Kasper W, Konstantinides S, Geibel A, Olschewski M, Heinrich F, Grosser KD, Rauber K, Iversen S, Redecker M, Kienast J. Management strategies and determinants of outcome in acute major pulmonary embolism: results of a multicenter registry. J Am Coll Cardiol. 1997 Nov 1;30(5):1165-71. doi: 10.1016/s0735-1097(97)00319-7.
PubMed 9350909Stein PD, Alnas M, Beemath A, Patel NR. Outcome of pulmonary embolectomy. Am J Cardiol. 2007 Feb 1;99(3):421-3. doi: 10.1016/j.amjcard.2006.08.050. Epub 2006 Dec 15.
PubMed 17261411Engelberger RP, Kucher N. Reperfusion Treatment for Acute Pulmonary Embolism. Hamostaseologie. 2018 May;38(2):98-105. doi: 10.1055/s-0038-1641717. Epub 2018 May 29.
PubMed 29843174Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.
PubMed 25856269Mohan B, Chhabra ST, Aslam N, Wander GS, Sood NK, Verma S, Mehra AK, Sharma S. Mechanical breakdown and thrombolysis in subacute massive pulmonary embolism: A prospective trial. World J Cardiol. 2013 May 26;5(5):141-7. doi: 10.4330/wjc.v5.i5.141.
PubMed 23710301Dilektasli AG, Demirdogen Cetinoglu E, Acet NA, Erdogan C, Ursavas A, Ozkaya G, Coskun F, Karadag M, Ege E. Catheter-Directed Therapy in Acute Pulmonary Embolism with Right Ventricular Dysfunction: A Promising Modality to Provide Early Hemodynamic Recovery. Med Sci Monit. 2016 Apr 15;22:1265-73. doi: 10.12659/msm.897617.
PubMed 27081754
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Catheter Directed Interventions in Acute High Risk Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03595085
- Acronym / sponsor ID
- CTPE
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 23 Jul 2018 (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.
Evaluating the safety and outcomes of catheter directed thrombolysis following catheter fragmentation in acute high risk pulmonary embolism
Detailed description
Acute pulmonary embolism is common, but its presentation highly varies ranging from asymptomatic to massive pulmonary embolism. Massive pulmonary embolism is a common life-threatening condition and represents the most serious manifestation among venous thromboembolic disease.
Acute pulmonary embolism is considered the third most common cause of death among hospitalized patients . The mortality rate can exceed 58% in patients with acute pulmonary embolism presenting with haemodynamic instability , mostly occur within 1 hour of presentation.
In patients with high risk pulmonary embolism , the main aim of therapy is to rapidly recanalize the affected pulmonary arteries with thrombolysis or embolectomy; to decrease right ventricular afterload and reverse right ventricular failure and shock, prevent chronic thromboembolic pulmonary hypertension , and decrease the recurrence risk.
The first-line treatment in patients with acute high risk pulmonary embolism presenting with persistent hypotension and/or cardiogenic shock is intravenous thrombolytic therapy. However a significant proportion of patients may not be a candidate for Intravenous thrombolysis because of major contraindications. An alternative option in patients with absolute contraindications or has failed intravenous thrombolysis is surgical embolectomy , but the number of experienced tertiary care centers that can do emergency surgical embolectomy are limited.
Percutaneous catheter mechanical fragmentation of proximal pulmonary arterial clots followed by local thrombolytic therapy is accepted as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow. Several reports have shown that catheter-directed therapy is a safe and effective treatment for acute PE to restore pulmonary flow and decreasing Pulmonary artery systolic pressure , However, current knowledge on efficacy and safety of catheter-directed therapy in management of intermediate high risk pulmonary embolism is limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| catheter directed interventions | Experimental | Procedure: catheter directed fragmentation and thrombolysisThose patients will undergo catheter directed fragmentation followed by local thrombolysis using streptokinase |
| systemic thrombolysis | Active comparator | Drug: StreptokinaseThose patients will receive systemic streptokinase |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with angiographically confirmed acute high risk pulmonary embolism with shock index >1.
- Pulmonary arterial occlusion with >50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure >25 mmHg)
- Patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis
- Patients with high risk pulmonary embolism who cannot receive fibrinolysis
- Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV dysfunction, or major myocardial necrosis)
Key exclusion criteria (8 listed)
- Patients with echocardiographically confirmed right sided thrombi.
- Patients with low-risk pulmonary embolism or intermediater-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
- Acute gastrointestinal bleeding.
- Anticoagulation with international normalized ratio >1.8 or severe coagulopathy.
- Anaphylactic reaction to contrast media.
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 |
|---|---|---|
| catheter directed fragmentation and thrombolysisA(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery. After ensuring initial flow, Initial bolus dose of streptokinase (250.000 international unit) will be given over 10 min followed by continuous infusion of (100.000 international unit per hour)for 24 hours | Procedure or surgery | catheter directed interventions |
| Streptokinaseintravenous streptokinase at a dose of 250 000 international unit as a loading dose over 30 minutes, followed by 100 000 international unit per hour over 12-24 hours | Drug | systemic thrombolysis |
Primary outcome
30-day mortality
Time frame: 30 days
measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis
3 secondary outcomes
Changes in blood pressure
Time frame: 24 hours
oxygen saturation
Time frame: 24 hours
changes in right ventricular dysfunction
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Background: PubMed 18296591Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available.
- Background: PubMed 25173341Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.
- Background: PubMed 11265879Uflacker R. Interventional therapy for pulmonary embolism. J Vasc Interv Radiol. 2001 Feb;12(2):147-64. doi: 10.1016/s1051-0443(07)61821-1.
- Background: PubMed 9350909Kasper W, Konstantinides S, Geibel A, Olschewski M, Heinrich F, Grosser KD, Rauber K, Iversen S, Redecker M, Kienast J. Management strategies and determinants of outcome in acute major pulmonary embolism: results of a multicenter registry. J Am Coll Cardiol. 1997 Nov 1;30(5):1165-71. doi: 10.1016/s0735-1097(97)00319-7.
- Background: PubMed 17261411Stein PD, Alnas M, Beemath A, Patel NR. Outcome of pulmonary embolectomy. Am J Cardiol. 2007 Feb 1;99(3):421-3. doi: 10.1016/j.amjcard.2006.08.050. Epub 2006 Dec 15.
- Background: PubMed 29843174Engelberger RP, Kucher N. Reperfusion Treatment for Acute Pulmonary Embolism. Hamostaseologie. 2018 May;38(2):98-105. doi: 10.1055/s-0038-1641717. Epub 2018 May 29.
- Background: PubMed 25856269Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.
- Background: PubMed 23710301Mohan B, Chhabra ST, Aslam N, Wander GS, Sood NK, Verma S, Mehra AK, Sharma S. Mechanical breakdown and thrombolysis in subacute massive pulmonary embolism: A prospective trial. World J Cardiol. 2013 May 26;5(5):141-7. doi: 10.4330/wjc.v5.i5.141.
- Background: PubMed 27081754Dilektasli AG, Demirdogen Cetinoglu E, Acet NA, Erdogan C, Ursavas A, Ozkaya G, Coskun F, Karadag M, Ege E. Catheter-Directed Therapy in Acute Pulmonary Embolism with Right Ventricular Dysfunction: A Promising Modality to Provide Early Hemodynamic Recovery. Med Sci Monit. 2016 Apr 15;22:1265-73. doi: 10.12659/msm.897617.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing catheter directed fragmentation and thrombolysis and Streptokinase in people with Pulmonary Embolism, run by Assiut University.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595085, which also lists 9 linked publications.
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 24 Jul 2018.