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

NCT06110949 | Recruiting DMC

• 1 other identifier: PI_2021/100//PI_2022/91
• Study Type: observational
• Target: 1,953
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Thromboprophylaxis; Thromboembolism; Atrial Fibrillation; Accelerometry; Hospital at Home

Outcome Measures

Primary Outcomes (6)

• Estimated thrombotic risk at admission measured with Padua score

  Estimated thrombotic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with Padua score (high or low risk). "Padua" score is a risk assessment model that scores from 0 to 20, with a score of 4 or higher identifying patients at "high risk" of thromboembolic disease.

  Within 3 months after hospitalization

• Estimated thrombotic risk at admission measured with IMPROVE-VTE score

  Estimated thrombotic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with IMPROVE-VTE score (high or low risk). "IMPROVE-VTE" score is a risk assessment model that scores from 0 to 12, with a score of 2 or higher identifying patients at "high risk" of thromboembolic disease.

  Within 3 months after hospitalization

• Estimated hemorrhagic risk at admission

  Estimated hemorrhagic risk of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units will be measured with IMPROVE-Bleeding score (high or low risk). "IMPROVE-Bleeding" score is a risk assessment model that scores from 0 to 33, with a score of 7 or higher identifying patients at "high risk" of hemorrhagic events.

  Within 3 months after hospitalization

• Incidence of thrombotic events

  Incidence of thrombotic events (deep venous thrombosis and pulmonary embolism) of patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units

  Within 3 months after hospitalization

• Incidence of atrial fibrillation diagnosis

  Incidence of atrial fibrillation diagnosis in patients admitted with acute medical diseases to at home hospitalization units and conventional hospitalization units

  Within 3 months after hospitalization

• Accelerometry

  A GENEActiv watch will be used on left wrist at a sampling rate of 85,70 Hz to measure movement in the x, y, and z direction. The results will be the duration of sleep, the time spent in sedentary attitudes and the amount of light, moderate and vigorous physical activity. All the outcomes may range from 1 to 1440 minutes per day.

  The duration of the hospitalization, from 0,9 days to 9 days

Secondary Outcomes (14)

• Prevalence of reduced mobility, measured with self-perceived immobilization

  Baseline

• Prevalence of reduced mobility, measured with accelerometry

  The duration of the hospitalization, from 0,9 days to 9 days

• Concordance of self-perceived immobilization and objective accelerometry measurements of physical activity for reduced mobility identification

  At admission and during the duration of the hospitalization, from 0,9 days to 9 days

• International Physical Activity Questionnaire (IPAQ)

  First day of hospitalization and 3 months after hospitalization

• The Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)

  First day of hospitalization and 3 months after hospitalization

Study Arms (2)

At home hospitalization cohort

Participants admitted with acute medical diseases to at home hospitalization units will be included in a prospective registry in order to investigate the 90 days incidence of thromboembolic disease. A group of such patients will be controlled with triaxial accelerometer in order to collect raw data regarding patient mobility during admission.

Device: Triaxial accelerometry

Conventional hospitalization cohort

Participants admitted with acute medical diseases to a conventional hospitalization unit will be included in a prospective registry in order to investigate the 90 days incidence of thromboembolic disease. A group of such patients will be controlled with triaxial accelerometer in order to collect raw data regarding patient mobility during admission.

Device: Triaxial accelerometry

Interventions

Triaxial accelerometry DEVICE

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).

At home hospitalization cohort; Conventional hospitalization cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with acute medical diseases (non-surgical setting) to either a conventional hospitalization unit or at home hospitalization units, whenever able to understand the study protocol and sign the informed consent form, will be offered to participate in this study. In patients' best interests, those with end-of-life disease, receiving palliative care or with an expected life survival inferior to 3 months will not be included. To correctly evaluate the study outcomes, patients receiving therapeutic doses of any anticoagulant drug, those with active diagnosis of thromboembolic disease or prior diagnosis of atrial fibrillation will not be included. Finally, this study excludes pregnant or breast-feeding people and patients with active or recent SARS-CoV2 infection, due to well recognized differences in the pathophysiology of thromboembolic disease in such populations.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pública de Navarra: lead
• Sociedad Española De Medicina Interna: collaborator
• Daiichi Sankyo: collaborator

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Atrial Fibrillation; Sedentary Behavior; Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Joao Modesto dos Santos, Medical Doctor

  Hospital Universitario de Navarra, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao Modesto dos Santos, Medical Doctor

CONTACT

0034689208762; jmodestosantos@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: November 1, 2023
• Study Start: March 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: March 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)