NCT04439383

Brief Summary

Hospital-acquired venous thromboembolism (HA-VTE) is one of the leading preventable causes of in-hospital mortality, but prevention of VTE in hospitalized medical patients remains challenging, as preventive measures such as pharmacological thromboprophylaxis (TPX) need to be tailored to individual thrombotic risk. The broad objective of this project is to improve VTE prevention strategies in hospitalized medical patients by prospectively examining VTE risk factors (including mobility) and comparing existing risk assessment models.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,353

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

June 15, 2020

Last Update Submit

April 4, 2022

Conditions

Venous ThromboembolismVenous ThrombosesPulmonary EmbolismDeep Vein ThrombosisEmbolism and ThrombosisMobility LimitationHospital Acquired Condition

Keywords

Venous thromboembolismPulmonary embolismDeep vein thrombosisRisk factorHospital-acquiredMobilityAccelerometry

Outcome Measures

Primary Outcomes (1)

  • Venous thromboembolism

    Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism after hospital admission

    Within 90 days of initial hospital admission

Secondary Outcomes (7)

  • Venous thromboembolism

    During the initial hospitalization, an average of 7 days

  • All-cause mortality

    During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission

  • Major bleeding

    During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission

  • Clinically relevant non-major bleeding

    During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission

  • Patient autonomy in the activities of daily living

    At discharge (an average of 7 days after initial hospital admission) and at 90 days after admission

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acutely ill adult patients hospitalized for at least 24h in general internal medicine of the participating tertiary care hospitals

You may qualify if:

  • Age ≥18 years
  • Admitted for hospitalization \>24 hours on a general internal medicine ward
  • Informed consent as documented by signature

You may not qualify if:

  • Need for therapeutic anticoagulation (e.g., atrial fibrillation)
  • Life expectancy \<30 days
  • Insufficient proficiency of the German or French language
  • Unwilling to provide informed consent
  • Prior enrolment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Inselspital, Bern University Hospital

Bern, Switzerland

Location

Geneva University Hospital

Geneva, Switzerland

Location

University Hospital of Lausanne

Lausanne, Switzerland

Location

Related Publications (1)

  • Choffat D, Farhoumand PD, Jaccard E, de la Harpe R, Kraege V, Benmachiche M, Gerber C, Leuzinger S, Podmore C, Truong MK, Dumans-Louis C, Marti C, Reny JL, Aujesky D, Rakovic D, Limacher A, Rossel JB, Baumgartner C, Mean M. Risk stratification for hospital-acquired venous thromboembolism in medical patients (RISE): Protocol for a prospective cohort study. PLoS One. 2022 May 24;17(5):e0268833. doi: 10.1371/journal.pone.0268833. eCollection 2022.

    PMID: 35609087DERIVED

MeSH Terms

Conditions

Venous ThromboembolismVenous ThrombosisPulmonary EmbolismEmbolism and ThrombosisMobility LimitationIatrogenic Disease

Condition Hierarchy (Ancestors)

ThromboembolismVascular DiseasesCardiovascular DiseasesThrombosisLung DiseasesRespiratory Tract DiseasesEmbolismSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Christine Baumgartner, MD, MAS

    Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR

  • Marie Méan, MD

    Centre Hospitalier Universitaire Vaudois, University Hospital of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 19, 2020

Study Start

June 22, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(3)