RecruitingNCT06110949

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)


Sponsor

Universidad Pública de Navarra

Enrollment

1,953 participants

Start Date

Mar 1, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the risk of blood clots (deep vein thrombosis or pulmonary embolism) in patients admitted to the hospital with acute medical illnesses — either in a conventional hospital ward or through hospital-at-home programs. The goal is to better understand and predict clot risk in these settings. **You may be eligible if...** - You are 18 or older - You have been admitted with an acute medical illness to either a hospital ward or a hospital-at-home unit - You are able and willing to give informed consent **You may NOT be eligible if...** - You have a terminal illness or are receiving palliative care, or have less than 3 months expected survival - You are already receiving therapeutic doses of blood thinners - You have an active blood clot - You have known atrial fibrillation - You are pregnant or breastfeeding - You tested positive for COVID-19 within the last 90 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETriaxial accelerometry

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)

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

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NCT06110949


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