Remote care for people with low-risk blood clots (DVT or PE)
Evaluation of Feasibility and Impact of Remote Care in Patients With Thromboembolic Disease of Low Risk
This study will test whether giving people with low-risk deep vein thrombosis or pulmonary embolism a 4G tablet and remote follow-up improves coordination of care and treatment adherence over 6 months and 1 year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Eure-Seine Academic / other |
| Locations | 1 site (Évreux) |
| Trial ID | NCT05684770 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study enrolls patients identified in the emergency department with low-risk thromboembolic disease (deep vein thrombosis or pulmonary embolism) and provides routine treatment per national guidelines plus a 4G tablet for education, questionnaires, remote consultations and adherence monitoring. Outcomes include feasibility of coordination between hospital physicians and primary care at 6 months and 1 year, plus complication rates, thromboembolism-related hospitalizations, and treatment compliance at those time points. Patients with major bleeding risk, severe comorbidities, renal failure, caval thrombosis, or contraindications to direct oral anticoagulants are excluded. The intervention focuses on remote organization and patient-facing digital support to determine whether it can safely streamline follow-up for low-risk patients.
Who should consider this trial
Good fit: Adults identified in the emergency department with DVT or PE judged to be low mortality risk, who are covered by social protection and able to use remote technology, are ideal candidates.
Not a fit: Patients with active bleeding or high hemorrhagic risk, severe renal failure, recent major surgery, caval thrombosis, cancer or other major comorbidities, contraindications to DOACs, or an inability to engage with remote care are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could reduce in-person visits, improve treatment adherence and coordination between providers, and potentially lower complication- and hospitalization rates for low-risk thromboembolic patients.
How similar studies have performed: Prior telemedicine and remote anticoagulation programs have shown promising improvements in follow-up and adherence, though results have varied and high-quality evidence for broad outcomes is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients identified in the emergency department with a thromboembolic disease, with a deep vein thrombosis or pulmonary embolism with a low risk of mortality according to recommendations * affiliated or beneficiary of social protection Exclusion Criteria: * patient having a severe obstruction syndrome, a thromboembolic disease already under treatment or a suspicion of thrombocytopenia induced by heparin * patient with an active hemorrhage or a major risk of hemorrhage, a renal severe failure, comorbidities such as cancer, or the impossibility to organise a consultation or a patient in a non favorable medico-social context * patient with a caval thrombosis * patient suffering of a disease at hemorrhagic risk or neurosurgery intervention done in the last month or other surgery in the last 15 days prior to inclusion * patient with contraindication of direct oral anticoagulants, such as bitherapy with antiplatelet agent, imidazoles, macrolides, antiretroviral treatments or an anti-phospholipid syndrome * patient that lives in an area not covered by internet * patient that has no primary care physician * patient not able to understand the study (language, psychological problem) or not able to read or write * patient under legal protection
Where this trial is running
Évreux
- Centre Hospitalier Eure-Seine — Évreux, France (Recruiting)
Study contacts
- Principal investigator: Vincent Eble, MD — CH Eure-Seine
- Study coordinator: Lydia BEN BEKKOU, ARC
- Email: arc2.circe@ch-eureseine.fr
- Phone: +332 32 33 86 75
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.