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.
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
- Conditions the study is for
- Pulmonary Embolism and Thrombosis, Extracorporeal Membrane Oxygenation, Percutaneous Pulmonary Thrombectomy
- 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.
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.
- Conditions
- Pulmonary Embolism and Thrombosis, Extracorporeal Membrane Oxygenation, Percutaneous Pulmonary Thrombectomy
- 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.
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)
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.
- First posted29 Jul 2024
- Study start22 Apr 2024
- Primary completion24 Jul 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism and ThrombosisStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Thromboembolism in Patients Undergoing Percutaneous Pulmonary Thrombectomy: Need for Mechanical Respiratory And/or Circulatory Assistance
- ClinicalTrials.gov ID
- NCT06525480
- Acronym / sponsor ID
- PR(AG)102/202
- Conditions
- Pulmonary Embolism and Thrombosis, Extracorporeal Membrane Oxygenation, Percutaneous Pulmonary Thrombectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 29 Jul 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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with intermediate/high risk pulmonary thromboembolism requiring percutaneous pulmonary thrombectomy
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Patients with high/intermediate risk of pulmonary embolism who undergo pulmonary mechanical thrombectomy
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Low-risk pulmonary embolism patients
- Patients who do not undergo pulmonary mechanical thrombectomy
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 |
|---|---|---|
| Percutaneous pulmonary thrombectomyPulmonary thrombus extraction | Procedure or surgery | – |
Primary outcome
Incidence and causes of hemodynamic and/or respiratory instability
Time frame: From the diagnosis of pulmonary embolism until 30 days after percutaneous pulmonary thrombectomy
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
1 secondary outcome
Need for ECMO treatment
Time frame: From the diagnosis of pulmonary embolism until 30 days after percutaneous pulmonary thrombectomy
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 4 Dec 2024.
- 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.
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 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.