Status:
RECRUITING
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.
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Non-severe Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 probl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06598930
Start Date
December 11 2024
End Date
July 1 2027
Last Update
December 18 2024
Active Locations (1)
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1
Chu Dijon Bourgogne
Dijon, France, 21000