Assessing thromboembolic risk in patients hospitalized at home versus traditional hospitals
Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization Units (TROMBODOM/ADOMFIB Study)
This study is trying to see if patients treated at home for acute medical issues have a different risk of blood clots compared to those treated in traditional hospitals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1953 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Pública de Navarra Academic / other |
| Locations | 1 site (Pamplona, Navarre) |
| Trial ID | NCT06110949 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the thromboembolic risk in patients admitted with acute medical diseases to at home hospitalization units versus conventional hospitalization units. It will recruit 1953 patients, collecting baseline clinical data and utilizing validated risk-assessment models like the Padua and IMPROVE-VTE scores. Additionally, mobility data will be gathered using triaxial accelerometers, and patients will be followed for 90 days post-discharge to monitor the incidence of thromboembolic events and bleeding complications. The study seeks to clarify the relationship between patient mobility and thromboembolic disease in different hospitalization settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older admitted with acute medical diseases to either conventional or at home hospitalization units.
Not a fit: Patients with end-of-life diseases, active thromboembolic conditions, or those receiving therapeutic anticoagulant doses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance thromboembolic risk assessment and prevention strategies for patients in various hospitalization settings.
How similar studies have performed: While the approach of assessing thromboembolic risk in home hospitalization settings is relatively novel, similar studies have shown success in traditional settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patients admitted with acute medical diseases to either a conventional hospitalization unit or at home hospitalization units * Capable and willing to provide an informed consent Exclusion Criteria: * End of life disease, palliative care or with an expected survival inferior to 3 months * Patients receiving therapeutic doses of any anticoagulant drug * Active diagnosis of thromboembolic disease * Prior diagnosis of atrial fibrillation * Pregnancy or breast-feeding. * SARS-CoV-2 diagnosed using real-time reverse transcriptase polymerase chain reaction (PCR) tests or positive for SARS-CoV-2 virus antigen \<90 days before randomization.
Where this trial is running
Pamplona, Navarre
- Hospital Universitario de Navarra — Pamplona, Navarre, Spain (Recruiting)
Study contacts
- Principal investigator: Joao Modesto dos Santos, Medical Doctor — Hospital Universitario de Navarra, Spain
- Study coordinator: Joao Modesto dos Santos, Medical Doctor
- Email: jmodestosantos@gmail.com
- Phone: 0034689208762
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.