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Pulmonary EmbolismNCT04099186

Hydro-mechanical Defragmentation of Pulmonary Embolism

A study testing catheter directed hydro-mechanical fragmentation of pulmonary embolism in people with Pulmonary Embolism, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluating the safety and outcomes of hydro-mechanical defragmentation of high risk pulmonary embolism with contraindication for thrombolytic therapy Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
catheter directed hydro-mechanical fragmentation of pulmonary embolism
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Sep 2019to 30 Jan 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 18 years and older
  • All sexes
  • No healthy volunteers
  • 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 cannot receive fibrinolysis
  • Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV (right ventricle) dysfunction, or major myocardial necrosis)

Who cannot join

  • Patients with echocardiographically confirmed right sided thrombi.
  • Patients with low-risk pulmonary embolism or intermediate-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
  • Anaphylactic reaction to contrast media.
  • Acute renal failure or severe chronic non-dialysis dependent kidney disease.
  • Uncooperative patient

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University

    Asyut, 71515

Other trials in Egypt

About this study

Official title: Evaluation of Safety and Efficacy of Hydro-mechanical Defragmentation of High Risk Pulmonary Embolism With Contraindications to Thrombolytic Therapy

Evaluating the safety and outcomes of hydro-mechanical defragmentation of high risk pulmonary embolism with contraindication for thrombolytic therapy

Read the detailed description

In 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 injection of 200 ml saline at high pressure using power injector can be used as an alternative to intravenous thrombolytic therapy and surgical embolectomy because of their ability to rapidly recanalize occluded pulmonary blood flow.

Being tested
catheter directed hydro-mechanical fragmentation of pulmonary embolism
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 hydro-mechanical fragmentation of pulmonary embolismProcedure 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 , then 200 ml saline will be injected via power injector to aid fragmentation of thrombus

Study groups in NCT04099186
Study groupRoleWhat they receive
hydro-mechanical pulmonary embolism fragmentationExperimentalThose patients will undergo catheter directed fragmentation followed by injection of 100 ml of heparinized saline via power injector
Receives: Procedure: catheter directed hydro-mechanical fragmentation of pulmonary embolism
thrombolytic treated armNo interventionpatients with high risk and intermediate high risk PE who received thrombolysis as only treatment modality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day mortality

    measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis

    Measured: 30 days

Secondary outcomes (2)

  1. 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

  2. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start1 Sep 2019
  3. Primary completion1 Nov 2020
  4. Study completion30 Jan 2021

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
non randomized case control trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04099186
Sponsor's protocol ID
HMDPE
Status last verified
Jul 2021
First submitted
20 Sep 2019
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Konstantinides 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 25173341

  • Uflacker 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 11265879

  • Engelberger 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 29843174

  • Kuo 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 25856269

  • Mohan 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 23710301

  • Dilektasli 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

  • Hassan AKM, Ahmed H, Ahmed Y, Elfadl AA, Omar A. Efficacy and safety of hydro-mechanical defragmentation in intermediate- and high-risk pulmonary embolism. Egypt Heart J. 2021 Sep 25;73(1):84. doi: 10.1186/s43044-021-00204-2.

    PubMed 34564780

Questions about this trial

What is this clinical trial studying?

A study testing catheter directed hydro-mechanical fragmentation of pulmonary embolism in people with 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 4 inclusion and 5 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 20 Jul 2021. 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 (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 NCT04099186, which also lists 7 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 20 Jul 2021.

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