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AzTrials

Venous ThromboembolismRISENCT04439383

Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients

An observational study of Venous Thromboembolism and Venous Thromboses, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,353 participants
Where
3 sitesSwitzerland
Study dates
22 Jun 2020to 1 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

  • Inselspital, Bern University Hospital

    Bern

  • Geneva University Hospital

    Geneva

  • University Hospital of Lausanne

    Lausanne

Other trials in Switzerland

About this study

Official title: Risk Stratification for Hospital-Acquired Venous Thromboembolism in Medical Patients: a Prospective Cohort Study

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.

Keywords
Venous thromboembolism, Pulmonary embolism, Deep vein thrombosis, Risk factor, Hospital-acquired, Mobility, Accelerometry
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Embolism and Thrombosis, Mobility Limitation, Iatrogenic Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Within 90 days of initial hospital admission

Secondary outcomes (7)

  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 during hospitalization

    Measured: During the initial hospitalization, an average of 7 days

  2. All-cause mortality

    All-cause mortality (all causes of death will be considered)

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

  3. Major bleeding

    Major bleeding will be defined as fatal bleeding, symptomatic bleeding at critical sites (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome), or bleeding with a reduction of hemoglobin of at least 20 g/L or bleeding leading to transfusion of 2 or more units of packed red blood cells according to the definition of the International Society on Thrombosis and Haemostasis

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

  4. Clinically relevant non-major bleeding

    Clinically relevant non-major bleeding, defined as overt bleeding that does not meet criteria for major bleeding but is associated with a medical intervention, unscheduled physician contact (visit or telephone call), or pain or impairment of activities of daily life

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

  5. Patient autonomy in the activities of daily living

    Patient autonomy in the activities of daily living as assessed by the modified Barthel Index

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

  6. Length of hospital stay

    Length of hospital stay, defined as the time/date of discharge minus time/date of admission at the hospital ward

    Measured: within 90 days of initial hospital admission

  7. Subsequent hospitalizations

    Subsequent hospitalization, defined as hospital readmissions

    Measured: Within 90 days of initial hospital admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start22 Jun 2020
  3. Primary completion1 Apr 2022
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04439383
Sponsor's protocol ID
RISE
Acronym
RISE
Status last verified
Apr 2022
First submitted
15 Jun 2020
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35609087

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Thromboembolism and Venous Thromboses, run by Insel Gruppe AG, University Hospital Bern at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Venous thromboembolism (time frame: Within 90 days of initial hospital admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04439383, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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