Comparing intensive follow-up care with standard care for patients with non-severe pulmonary embolism.
Evaluation of the Efficacy of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone, in Non-severe Pulmonary Embolism - Randomised Open Study At Dijon University Hospital and Langres University Hospital.
This study is testing whether more frequent check-ins with a nurse after being treated for non-severe pulmonary embolism can help patients do better than just regular follow-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT06598930 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intensive medical follow-up provided by an advanced practice nurse compared to standard medical follow-up for patients diagnosed with non-severe pulmonary embolism. The aim is to improve patient outcomes by reducing recurrence rates and complications associated with pulmonary embolism through enhanced monitoring and support. Participants will receive either routine follow-up or intensive follow-up after being discharged from the hospital. The study is conducted in France, focusing on patients treated at Dijon University Hospital or Langres University Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been diagnosed with non-severe pulmonary embolism and are residents in the specified regions.
Not a fit: Patients who are not affiliated with a social security system or those under legal protection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of non-severe pulmonary embolism, reducing recurrence and complications for patients.
How similar studies have performed: While similar approaches have been explored, this specific evaluation of intensive follow-up for non-severe pulmonary embolism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Anne-Lise ANTEMI-RIBREUX
- Email: anne-lise.antemi@chu-dijon.fr
- Phone: 0380669363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.