pulmonary embolism, clotting in the lung clotting in the lung
Conditions
Interventions
The intervention consists of immediate thrombectomy without systemic/locally administered thrombolysis. 
Thrombectomy is performed via jugular or femoral venous access by an interventional cardiologist, interventional radiologist or vascular surgeon according to the instructions for use (IFU) for the par
catheter using a syringe or dedicated aspiration system, with multiple aspirations performed as needed. Procedural objectives will be clearly stated prior to the intervention and patient*s clinical an
major CDT complications such as cardiac arrest or severe haemoptysis. Complications will be solved directly, with a procedure/treatment best suitable according to the treating physician, to minimalize
promote patient recovery.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients with confirmed acute PE, i.e. contrast filling defect in a lobar or more proximal pulmonary artery on computed tomography pulmonary angiography (CTPA), and/or obstructive shock with echocardiographic confirmed dilatation of the right ventricle and a congested vena cava inferior, both with/without echocardiographic signs of clot in transit or deep vein thrombosis of the leg. 2. High risk for mortality, i.e. a. post cardiac arrest (after temporary need for cardiopulmonary resuscitation), OR b. obstructive shock (systolic blood pressure <90 mmHg and signs of end-organ hypoperfusion (e.g. elevated lactate levels >2 mmol/l) or the need for vasopressors (adrenalin or noradrenalin) to maintain an adequate blood pressure), OR c. persistent hypotension (systolic blood pressure <90 mmHg or systolic blood pressure drop >=40 mmHg for at least 15 minutes) not caused by new onset arrhythmia, hypovolemia, or sepsis, OR d. abnormal RV function on transthoracic echocardiography or CTPA AND elevated cardiac troponin levels AND respiratory failure defined as hypoxemia (SaO2 <90%) refractory to O2 supplementation by nasal cannula or Venturi mask, requiring full face mask O2 supplementation (100% FiO2), high-flow nasal O2, or (non-)invasive mechanical ventilation. 3. CDT available and technically feasible so as to allow for a randomization-to-needle time of 60 minutes or less.
Exclusion criteria
Exclusion criteria: 1. ‘Catastrophic PE’, i.e. ongoing cardiac arrest and/or need for extracorporeal cardiopulmonary resuscitation (ECPR) and/or immediate indication for venoarterial extracorporeal membrane oxygenation (VA-ECMO) as judged by the responsible physician(s) 2. Glascow Coma Scale <8 following resuscitation for cardiac arrest 3. Alternative diagnosis than acute PE contributing largely to the acute hemodynamic and/or respiratory failure, e.g. sepsis, COPD GOLD 3 or 4, or known heart failure with NYHA Functional Classification of 4, as judged by the treating physician. 4. A known ‘do not admit to the ICU’ or ‘do not resuscitate’ directive 5. An absolute contraindication to systemic thrombolysis, i.e. - History of hemorrhagic stroke - Ischemic stroke in past 6 months - Central nervous system neoplasm - Major trauma, major surgery or major head injury in past 3 weeks (note: mild external laceration of the head after, e.g. syncope, does not count as major head injury, especially when a CT scan of the head shows no hematoma) - Active bleeding, life-threatening or into a critically organ/area; OR known severe bleeding diathesis with previous bleeding fulfilling these criteria 6. Reperfusion therapy (systemic thrombolysis, surgical thrombectomy or CDT/other catheter directed therapy), or placement of a non-retrieved inferior vena cava filter for acute pulmonary embolism in the past 3 months 7. Thrombus in transit through a patent foramen ovale. 8. Known chronic thromboembolic pulmonary hypertension (CTEPH), or strong suspicion of CTEPH based on pre-existing clinical findings and combinations of signs of PE chronicity on echocardiography and/or CTPA. 9. Known hypersensitivity to systemic thrombolysis, heparin, or to any of the excipients 10. If, in the Investigator's opinion, or after consultation with the local PERT-team or EC-members, the patient is not appropriate for thrombectomy 11. Chronic use of full-dose oral or parenteral anticoagulation before presentation. 12. Pregnancy 13. Current participation in another study that would interfere with participation in this study 14. Previous enrolment in this study 15. Refusal of deferred consent by the next of kin or by the patient himself to use the data. Deferred consent will not be asked to relatives of patients who die in scene, but are included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the 30-day composite incidence of the binary endpoints of: 1) all-cause mortality 2) treatment failure 3) major bleeding 4) and all-cause stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: - Survival at day 7 and day 30 - Treatment failure at day 7 and day 30 - All-cause mortality at day 7, day 30 and day 90 - All-cause stroke at day 7 and day 30 - The composite incidence of the binary endpoints of all-cause mortality, treatment failure, major bleeding and all-cause stroke at day 7 - Desirability of Outcome Ranking (DOOR) at day 722 - BARC3b and BARC3c bleeding, at day 7 and day 30 - ISTH major and non-major clinically relevant bleeding at day 7 and day 30 - Oxygen supplementation (LO2/min) at 48 hours - Length of stay (days) at the ICU and in hospital at day 30 - Quality of life, functional status and symptom burden symptom burden at day 7 and after 3, 6, 9 and 12 months according to the ICHOM-VTE set - Cost-effectiveness analysis with a time horizon of one year and budget impact analysis | — |
Countries
Netherlands
Contacts
Public ContactF.A. Klok
Leids Universitair Medisch Centrum
Outcome results
None listed