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Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization

NCT06110949 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1953

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

  • Thromboprophylaxis
  • Thromboembolism, Venous
  • Atrial Fibrillation
  • Physical Inactivity
  • Hospital at Home

Interventions

DEVICE

Triaxial 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).

Sponsors & Collaborators

  • Sociedad Española De Medicina Interna

    collaborator OTHER

  • Daiichi Sankyo

    collaborator INDUSTRY

  • Universidad Pública de Navarra

    lead OTHER

Principal Investigators

  • Joao Modesto dos Santos, Medical Doctor · Hospital Universitario de Navarra, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-01-31
Completion
2025-03-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06110949 on ClinicalTrials.gov