Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06833827

'Thrombectomy in High-Risk Pulmonary Embolism - Device Versus Thrombolysis Netherlands': TORPEDO-NL

Led by Leiden University Medical Center · Updated on 2025-02-19

111

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

L

Leiden University Medical Center

Lead Sponsor

D

Dutch Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for patients with high-risk pulmonary embolism (PE), a serious condition that requires immediate clot removal in addition to blood thinners. This trial compares two approaches: catheter-directed thrombectomy (CDT), a procedure that directly removes clots using a device, versus standard full-dose systemic thrombolysis, which dissolves clots using medication. The study aims to see if CDT can reduce death rates and serious complications better than the usual treatment, while also improving recovery and quality of life over one year. Participants are randomly assigned to one of two groups. One group receives the CDT procedure, where a catheter is guided through veins to the lungs to extract clots using suction, combined with blood thinners during the procedure. The other group receives full-dose systemic thrombolysis using clot-dissolving drugs such as Alteplase, Urokinase, or Tenecteplase. The study is open-label, meaning both patients and doctors know which treatment is given. Researchers will monitor effects at various points, including day 7, day 30, and up to one year after treatment. During the trial, participants undergo evaluations including clinical and hemodynamic assessments to determine treatment success, monitoring of oxygen levels, length of stay in intensive care and hospital, and quality of life questionnaires over a year. The main measure is a combined rate of death, treatment failure, major bleeding, and stroke at 30 days. Secondary outcomes include survival, bleeding events, oxygen use, and long-term functional recovery. Cost-effectiveness of the treatments will also be analyzed after one year.

CONDITIONS

Brief Title

'Thrombectomy in High-Risk Pulmonary Embolism - Device Versus Thrombolysis Netherlands': TORPEDO-NL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with confirmed acute pulmonary embolism as shown by imaging or echocardiography
  • High risk for mortality defined by cardiac arrest, obstructive shock, persistent low blood pressure, or abnormal right heart function with respiratory failure
  • Catheter-directed thrombectomy (CDT) must be available and technically feasible with randomization-to-needle time of 60 minutes or less
Not Eligible

You will not qualify if you...

  • Ongoing cardiac arrest or need for extracorporeal cardiopulmonary resuscitation or immediate extracorporeal membrane oxygenation
  • Glasgow Coma Scale below 8 after cardiac arrest resuscitation
  • Alternative diagnosis causing acute failure like sepsis, severe COPD, or advanced heart failure
  • "Do not resuscitate" or "do not admit to ICU" directives
  • Absolute contraindications to systemic thrombolysis including recent hemorrhagic or ischemic stroke, brain tumors, recent major trauma or surgery, active or severe bleeding
  • Reperfusion therapy or vena cava filter placement within past 3 months
  • Thrombus passing through a patent foramen ovale
  • Known or suspected chronic thromboembolic pulmonary hypertension
  • Known allergies to thrombolysis medication or heparin
  • Judged inappropriate for thrombectomy by investigators
  • Chronic use of full-dose anticoagulation before presentation
  • Pregnancy
  • Participation in interfering clinical studies
  • Previous enrollment in this study
  • Refusal of deferred consent by patient or next of kin

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Immediate intervention with follow-up up to 30 days

Participants receive either catheter-directed thrombectomy or systemic thrombolysis as treatment for high-risk pulmonary embolism.

1 treatment visit followed by multiple assessments up to 30 days

Follow-up

Duration - Up to 1 year

Participants are monitored for treatment outcomes, safety, and recovery including survival, bleeding events, and quality of life.

Visits at day 7, day 30, and additional assessments at 3, 6, 9, and 12 months

Trial Site Locations

Total: 1 location

1

Leiden University Medical Centre

Leiden, South Holland, Netherlands, 2333ZA

Actively Recruiting

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Research Team

W

W. J.E. Stenger, MD

F

F. A. Klok, Prof. MD. PhD.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Novel Risk Stratification and Hemodynamic Profiling in Acute Pulmonary Embolism: A Proposed Classification Inspired by Society for Cardiovascular Angiography and Intervention Shock Staging.

Sonali Arora, Saraschandra Vallabhajosyula, Vikas Aggarwal...

https://pubmed.ncbi.nlm.nih.gov/38964819

Development of an international standard set of outcome measures for patients with venous thromboembolism: an International Consortium for Health Outcomes Measurement consensus recommendation.

Adam M Gwozdz, Cindy M M de Jong, Luz Sousa Fialho...

https://pubmed.ncbi.nlm.nih.gov/36055334

Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

Roxana Mehran, Sunil V Rao, Deepak L Bhatt...

https://pubmed.ncbi.nlm.nih.gov/21670242

Usefulness of standard computed tomography pulmonary angiography performed for acute pulmonary embolism for identification of chronic thromboembolic pulmonary hypertension: results of the InShape III study.

Yvonne M Ende-Verhaar, Lilian J Meijboom, Lucia J M Kroft...

https://pubmed.ncbi.nlm.nih.gov/30962147

Systemic Thrombolysis Therapy is Associated With Improved Outcomes Among Patients With Acute Pulmonary Embolism and Respiratory Failure.

Matthew Koslow, Gali Epstein Shochet, Feda Fenadka...

https://pubmed.ncbi.nlm.nih.gov/32466857