Actively Recruiting
'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
204 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
TORPEDO-NL will be an investigator-initiated, academically sponsored, multicentre, open-label, randomized controlled trial (RCT). Patients with high-risk pulmonary embolism (PE) require immediate reperfusion therapy on top of anticoagulation. The standard reperfusion treatment in these patients is full-dose systemic thrombolysis. This carries a significant risk of major bleeding (10-25%) and intracranial haemorrhage (ICH, 3%). Catheter-directed thrombectomy (CDT) is a promising alternative to systemic thrombolysis with a more direct effect on reducing pulmonary artery clot burden and very likely a better safety profile. Randomized trials evaluating the safety and efficacy of CDT in high-risk patients are currently unavailable. The investigators hypothesize that in high-risk PE patients, CDT is superior to the current standard of systemic thrombolysis in terms of mortality and adverse events, i.e., is associated with a lower composite incidence of all-cause mortality, treatment failure, major bleeding and all-cause stroke. The investigators also hypothesize that CDT will lead to a shorter length of stay (LOS) at the intensive care unit (ICU) and in-hospital, faster recovery, and better long-term quality of life (QoL). Objective: To determine whether CDT in high-risk PE relative to systemic thrombolysis is: * more effective and safer in terms of a reduction of the composite endpoint on all-cause mortality and adverse events defined as treatment failure, major bleeding and all-cause stroke at day 30 (primary outcome) * leads to a better Desirability of Outcome Ranking (DOOR) at day 7 * associated with a lower level of oxygen supplementation at 48 hours * associated with shorter length of stay (LOS) at the intensive care unit (ICU) and in the hospital * associated with better functional recovery as well as better patient-reported outcomes such as QoL at one year * cost-effective after a time horizon of one year
CONDITIONS
Official Title
'Thrombectomy in High-Risk Pulmonary Embolism - Device Versus Thrombolysis Netherlands': TORPEDO-NL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with confirmed acute pulmonary embolism by imaging or echocardiography
- High risk for mortality defined by post cardiac arrest, obstructive shock, persistent low blood pressure, or abnormal right ventricular function with respiratory failure
- Catheter-directed thrombectomy available and feasible with randomization-to-needle time of 60 minutes or less
You will not qualify if you...
- Ongoing cardiac arrest or need for extracorporeal cardiopulmonary resuscitation or immediate VA-ECMO
- Glasgow Coma Scale less than 8 after resuscitation for cardiac arrest
- Alternative diagnosis causing hemodynamic or respiratory failure like sepsis, severe COPD, or advanced heart failure
- Do not admit to ICU or do not resuscitate directive
- Absolute contraindications to systemic thrombolysis including history of hemorrhagic stroke, recent ischemic stroke, CNS neoplasm, recent major trauma or surgery, active or severe bleeding
- Reperfusion therapy or inferior vena cava filter placement in past 3 months
- Thrombus in transit through patent foramen ovale
- Known or suspected chronic thromboembolic pulmonary hypertension
- Known hypersensitivity to thrombolysis, heparin, or excipients
- Deemed inappropriate for thrombectomy by investigator
- Chronic use of full-dose anticoagulation before presentation
- Pregnancy
- Participation in another interfering study
- Previous enrollment in this study
- Refusal of deferred consent by patient or next of kin
AI-Screening
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Trial Site Locations
Total: 1 location
1
Leiden University Medical Centre
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
Research Team
W
W. J.E. Stenger, MD
CONTACT
F
F. A. Klok, Prof. MD. PhD.
CONTACT
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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