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Pulmonary Embolism and ThrombosisNCT06525480

Mechanical Respiratory/circulatory Support in Patients with Pulmonary Thrombectomy

An observational study of Pulmonary Embolism and Thrombosis and Extracorporeal Membrane Oxygenation, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

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

Pulmonary embolism (PE) results from embolization of venous thrombi in the branches of the pulmonary arteries. Although anticoagulation is usually the preferred method of treatment, patients with high-risk and/or intermediate/high-risk pulmonary embolism may benefit from immediate reperfusion therapy, such as… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Percutaneous pulmonary thrombectomy
Type of treatment
Surgery or procedure
How many people
77 participants
Where
1 siteSpain
Study dates
22 Apr 2024to 30 Nov 2024
Phase
Observational
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

Study population: Adult patients with intermediate/high risk pulmonary thromboembolism requiring percutaneous pulmonary thrombectomy

Who may be able to join

  • Patients over 18 years of age
  • Patients with high/intermediate risk of pulmonary embolism who undergo pulmonary mechanical thrombectomy

Who cannot join

  • Patients under 18 years of age
  • Low-risk pulmonary embolism patients
  • Patients who do not undergo pulmonary mechanical thrombectomy

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Vall d´Hebron Research Institute VHIR

    Barcelona, Barcelona, 08035

Other trials in Spain

About this study

Official title: Pulmonary Thromboembolism in Patients Undergoing Percutaneous Pulmonary Thrombectomy: Need for Mechanical Respiratory And/or Circulatory Assistance

Pulmonary embolism (PE) results from embolization of venous thrombi in the branches of the pulmonary arteries.

Although anticoagulation is usually the preferred method of treatment, patients with high-risk and/or intermediate/high-risk pulmonary embolism may benefit from immediate reperfusion therapy, such as mechanical catheter thrombectomy. During this procedure, there may be an increase in pulmonary pressures caused by the introduction of pulmonary catheters, which may trigger hemodynamic instability. In addition, anesthesia performed during percutaneous mechanical thrombectomy may precipitate hemodynamic and respiratory compromise due to hypoxia, hypercapnia and increased airway pressure.

We will perform a retrospective, single-center study to determine the incidence and immediate causes of hemodynamic and/or respiratory deterioration, before, during and after (first 30 days) of percutaneous pulmonary thrombectomy, as well as the need for mechanical respiratory/circulatory support.

Read the detailed description

Pulmonary embolism (PE) is a consequence of the embolization of venous thrombi in the branches of the pulmonary arteries. It affects approximately 1 in 1,000 people per year worldwide and represents the third cause of cardiovascular death.

The degree of hemodynamic compromise due to PE can be determined by imaging studies, such as computed tomography angiography, transthoracic echocardiography (TTE), and transesophageal echocardiography (TEE). Additionally, laboratory tests may suggest circulatory compromise, such as elevated levels of cardiac troponin and N-terminal pro b-type natriuretic peptide (NT-proBNP) at the time of PE presentation.

There are different classifications to evaluate the severity of PE and we consider the presence of hemodynamic instability to differentiate high-risk PE from intermediate-risk PE. The presence of hemodynamic instability includes a state of obstructive shock (signs of hypoperfusion associated with a systolic blood pressure (SBP) <90mmHg, and/or SBP ≥ 90mmHg with the need for vasoactive drugs), persistent hypotension (SBP<90mmHg for ≥ 15 min or SBP decrease ≥ 40mmHg compared to baseline) or cardiac arrest with the need for cardiopulmonary resuscitation (CPR). The high risk of PE also includes the existence of some parameter included in the sPESI such as: history of cancer, age over 80 years, heart rate ≥ 110 bpm, history of chronic obstructive pulmonary disease, SBP <100 mmHg and SpO2 <90%.

Patients with high-risk and/or intermediate/high-risk pulmonary embolism benefit from immediate reperfusion therapy, such as systemic thrombolysis, catheter-directed thrombolysis, catheter thrombectomy or surgery. Although the incidence of complications and mortality in high-risk PE patients has been determined, the incidence and immediate causes of hemodynamic and/or respiratory deterioration before, during, and after pulmonary thrombectomy are unknown. Pulmonary thrombectomy is a technique that consists of the extraction or dissolution, using endovascular devices, of the thrombus that partially or totally obstructs a pulmonary artery. It is generally associated with the local intra-thrombus administration of thrombolytic drugs. The increase in pulmonary intravascular pressure generated during the procedure can trigger the appearance of complications (arrhythmias, acute overload of the right ventricle, hemodynamic and/or respiratory instability, shock, cardiovascular arrest). These complications usually require an increase in hemodynamic support (with an increase in vasoactive drugs) and/or respiratory support (orotracheal intubation and mechanical ventilation), and even mechanical support with ECMO, usually veno-arterial ECMO for cardiovascular assistance. Also, the type of anesthesia performed can precipitate the hemodynamic and/or respiratory compromise of patients due to the possible presence of hypoxia and hypercapnia in patients who present hypoventilation, and the increase in airway pressures caused by orotracheal intubation and mechanical ventilation. In some cases, the use of mechanical circulatory support, usually ECMO, may be justified; but it is currently unclear whether VA-ECMO should be initiated in all high-risk PE patients. It must be considered that VA-ECMO is associated with innumerable complications (bleeding, thrombi, vascular complications), which increase the longer the duration of support.

Determining the incidence and causes or context of the onset of hemodynamic and/or respiratory deterioration (leading to shock, need for orotracheal intubation, cardiopulmonary arrest and/or mechanical support with ECMO), before, during and after thrombectomy pulmonary disease, could help reduce the morbidity and mortality of these patients.

Being tested
Percutaneous pulmonary thrombectomy
Medical subject headings
Pulmonary Embolism, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous pulmonary thrombectomyProcedure or surgery

    Pulmonary thrombus extraction

What is being measured

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

  1. Incidence and causes of hemodynamic and/or respiratory instability

    Determine the incidence and immediate causes of hemodynamic and/or respiratory instability in patients with intermediate/high risk of pulmonary embolism.

    • Hemodynamic instability: obstructive shock (signs of hypoperfusion associated with a systolic blood pressure (SBP) <90mmHg, and/or SBP ≥ 90mmHg with the need for vasoactive drugs), persistent hypotension (SBP<90mmHg for ≥ 15 min or SBP decrease ≥ 40mmHg compared to baseline) or cardiac arrest with the need for cardiopulmonary resuscitation
    • Respiratory instability: SpO2 <90%, dyspnea

    Measured: From the diagnosis of pulmonary embolism until 30 days after percutaneous pulmonary thrombectomy

Secondary outcomes (1)
  1. Need for ECMO treatment

    Determine the percentage of patients who require ECMO and its associated complications (hemorrhage, thrombosis, ischemia)

    Measured: From the diagnosis of pulmonary embolism until 30 days after percutaneous pulmonary thrombectomy

Timeline

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

  1. First posted29 Jul 2024
  2. Study start22 Apr 2024
  3. Primary completion24 Jul 2024
  4. Study completion30 Nov 2024

Resources

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 only
Time perspective
Retrospective
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06525480
Sponsor's protocol ID
PR(AG)102/202
Status last verified
Jul 2024
First submitted
24 Jul 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Embolism and Thrombosis and Extracorporeal Membrane Oxygenation, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

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 2 inclusion and 3 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 4 Dec 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 Spain. 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?

Incidence and causes of hemodynamic and/or respiratory instability (time frame: From the diagnosis of pulmonary embolism until 30 days after percutaneous pulmonary thrombectomy). 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 4 Dec 2024.

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