Mechanical Respiratory/circulatory Support in Patients with Pulmonary Thrombectomy

NCT06525480 | Completed DMC

• 1 other identifier: PR(AG)102/202
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pulmonary Embolism and Thrombosis; Extracorporeal Membrane Oxygenation; Percutaneous Pulmonary Thrombectomy

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (1)

• Need for ECMO treatment

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

Interventions

Percutaneous pulmonary thrombectomy PROCEDURE

Pulmonary thrombus extraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d´Hebron Research Institute VHIR

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: April 22, 2024
• Primary Completion: July 24, 2024
• Study Completion: November 30, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)