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Evaluation of the Effectiveness of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone in Non-severe Pulmonary Embolism.

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Universitaire Dijon
NCT06598930 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In France, venous thromboembolism (VTE), which includes pulmonary embolism (PE) and deep-vein thrombosis (DVT), is the 3rd leading cause of cardiovascular disease, leading to major public health problems. Despite current monitoring and treatment, the recurrence rate and the rate of haemorrhagic complications remain high, at 18.5% and 12% respectively in the year following the thrombotic event. Patients with PE diagnosed in the emergency department are very often admitted to hospital. However, according to international recommendations on the treatment of PE, outpatient management with early discharge could be envisaged but is rarely carried out in practice, particularly for non-severe PE (spESI = 0). Current post-pulmonary embolism follow-up involves an early medical consultation with a specialist after discharge from hospital, with follow-up at 1, 3 and 6 months. The aim is to evalua

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📋 Eligibility rules (as published)
Inclusion Criteria: * Person who has given oral consent * Person affiliated to the social security system * Over 18 years of age * Resident in the 21-52 region * Emergency care at Dijon University Hospital or Langres University Hospital less than 24 hours after diagnosis of non-severe pulmonary embolism (spESI = 0) Symptomatic PE is confirmed if there is : * a high pre-test clinical probability and a high probability ventilation-perfusion (V/Q) lung scan according to the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) criteria * a proximal DVT diagnosed by ultrasound in a patient with symptoms of PE; * a positive CT pulmonary angiogram (PA) showing a central filling defect highlighted by contrast material or a complete occlusion in a segmental or more proximal pulmonary artery. * No contraindication to anticoagulant treatment Exclusion Criteria: * Person not affiliated to or not benefiting from a social security scheme * Person subject to a legal protection measure (curatorship, guardianship) * Person subject to a legal protection measure * Pregnant women, women in labour or breastfeeding mothers * An adult who is incapable or unable to give consent * Minors * Contraindication to anticoagulant treatment
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What it tests

  • Routine follow-up
  • Intensive follow-up
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Where

1 site
Chu Dijon Bourgogne
Dijon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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