Clinical trial NCT06110949: Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization
Official title: Thromboembolic Risk Assessment in Patients Admitted With Acute Medical Diseases to Conventional and At Home Hospitalization Units (TROMBODOM/ADOMFIB Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thromboprophylaxis
Thromboembolism, Venous
Atrial Fibrillation
Physical Inactivity
Hospital at Home
Keywords: Thromboprophylaxis
Thromboembolism
Atrial Fibrillation
Accelerometry
Hospital at Home
Lead sponsor: Universidad Pública de Navarra
Sponsor class: OTHER
Collaborators: name: Sociedad Española De Medicina Interna
name: Daiichi Sankyo
First posted: 2023-11-01
Enrollment: 1953
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 1953 patients will be recruited (1700 in at home hospitalization units and 253 in conventional hospitalization units). All patients must accept and sign the informed consent. After being admitted to the study, patients will be included in the prospective registry with baseline evaluation of basic clinical data, including risk-assessment models (Padua and IMPROVE-VTE scores), examination, ECG, self-assessed mobility, and biochemistry markers. Triaxial accelerometers will also record mobility and sleep time of 135 patients from conventional hospitalization units and 135 patients from at home hospitalization units, from which physical activity questionnaires (International Physical Activity Questionnaire (IPAQ), The Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)), handgrip strength, 30-second sit-to-stand test, the Short Physical Performance Battery (SPPB), the Spanish Version of 5-level European Quality of Life-5 Dimensions (5-level EQ-5D), Fried frailty criteria and Lobo's cognitive mini-examination will also be obtained. All 1953 patients will be followed for 90 days after discharge to assess thromboembolic disease incidence (pulmonary embolism, deep venous thrombosis, and atrial fibrillation), major and clinically relevant non-major bleedings (according to International Society on Thrombosis and Haemostasis Standards) and death.

Eligibility 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.

Primary outcomes:
measure: Estimated thrombotic risk at admission measured with Padua score
timeFrame: Within 3 months after hospitalization
measure: Estimated thrombotic risk at admission measured with IMPROVE-VTE score
timeFrame: Within 3 months after hospitalization
measure: Estimated hemorrhagic risk at admission
timeFrame: Within 3 months after hospitalization
measure: Incidence of thrombotic events
timeFrame: Within 3 months after hospitalization
measure: Incidence of atrial fibrillation diagnosis
timeFrame: Within 3 months after hospitalization
measure: Accelerometry
timeFrame: The duration of the hospitalization, from 0,9 days to 9 days
Secondary outcomes:
measure: Prevalence of reduced mobility, measured with self-perceived immobilization
timeFrame: Baseline
measure: Prevalence of reduced mobility, measured with accelerometry
timeFrame: The duration of the hospitalization, from 0,9 days to 9 days
measure: Concordance of self-perceived immobilization and objective accelerometry measurements of physical activity for reduced mobility identification
timeFrame: At admission and during the duration of the hospitalization, from 0,9 days to 9 days
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: First day of hospitalization and 3 months after hospitalization
measure: The Spanish Short Version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM)
timeFrame: First day of hospitalization and 3 months after hospitalization
measure: Handgrip strength
timeFrame: First (baseline) and last day of hospitalization (up to 9 days)
measure: 30-second sit-to-stand test
timeFrame: First (baseline) and last day of hospitalization (up to 9 days)
measure: The Short Physical Performance Battery (SPPB)
timeFrame: First (baseline) and last day of hospitalization (up to 9 days)
measure: The Spanish Version of 5-level European Quality of Life-5 Dimensions (5-level EQ-5D)
timeFrame: First day of hospitalization (baseline)
measure: Fried frailty criteria
timeFrame: First day of hospitalization (baseline)
measure: Lobo's cognitive mini-examination
timeFrame: First day of hospitalization (baseline)
measure: Prevalence of pharmacological thromboprophylaxis use
timeFrame: Last day of hospitalization (up to 9 days)
measure: Prevalence of correct pharmacological thromboprophylaxis use according to risk assessment models
timeFrame: Last day of hospitalization (up to 9 days)
measure: Prevalence of correct pharmacological thromboprophylaxis use according to objective mobility evaluation with accelerometry
timeFrame: Last day of hospitalization (up to 9 days)
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
Study officials:
affiliation: Hospital Universitario de Navarra, Spain
name: Joao Modesto dos Santos, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: