Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization
Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization Units (TROMBODOM/ADOMFIB Study)
Universidad Pública de Navarra
1,953 participants
Mar 1, 2023
OBSERVATIONAL
Conditions
Summary
The thromboembolic disease is a common complication of patients admitted to conventional hospitalization units. To prevent such complications, thromboprophylaxis is indicated in high-risk patients identified with validated risk-assessment models such as Padua score and IMPROVE-VTE score. However, the relation between thromboembolic disease and inpatients is yet to be demonstrated in new clinical settings such as at home hospitalization units. Moreover, patient immobilization is key in the pathogenesis of thromboembolic complications: therefore, it is crucial to collect raw data of patient mobility during admission. The goal of this observational study is to compare the thromboembolic risk of patients admitted with acute medical diseases to at home hospitalization units with conventional hospitalization units. The main questions it aims to answer are: * Is the estimated thromboembolic risk of patients admitted with acute medical diseases to at home hospitalization units similar to those admitted to conventional hospitalization units? * Are the risk-assessment models used to predict thromboembolic risk of patients admitted with acute medical diseases to conventional hospitalization units (Padua and IMPROVE-VTE score) valid in at home hospitalization patients? Participants admitted with acute medical diseases to either a conventional hospitalization unit or at home hospitalization units will be included in a prospective registry in order to investigate the 90 days incidence of thromboembolic disease. A cohort of such patients will be controlled with triaxial accelerometer in order to collect raw data regarding patient mobility during admission.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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.
Interventions
A group of patients will be controlled with triaxial accelerometer (GENEActiv watch) on left wrist at a sampling rate of 85,70 Hz to measure movement in the x, y, and z direction, in order to collect raw data regarding patient mobility (duration of sleep, the time spent in sedentary attitudes and the amount of light, moderate and vigorous physical activity) during the admission (from the admission day to discharge).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06110949