Venous ThromboembolismTPX-ENHANCENCT05306821
Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study
A study testing Comprehensive electronic tool in the electronic medical chart, Educative sessions and Pocket card in people with Venous Thromboembolism, run by Marc Blondon at 2 sites in Switzerland.
Trial summary
The primary objective is to evaluate and compare the short-term and medicum-term effectiveness of 2 types of interventions in 2 different hospitals to improve the adequacy of hospital thromboprophylaxis among acute medical inpatients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Comprehensive electronic tool in the electronic medical chart, Educative sessions and Pocket card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Sep 2020to 31 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- acute medical inpatients hospitalized at the Geneva University Hospitals or the Lugano Regional Hospitals
Who cannot join
- patients already on therapeutic anticoagulation
- patients with an estimated life expectancy of <3 months
- pregnancy
- patients hospitalized for COVID-19
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
Geneva University Hospitals
Geneva
Marc Blondon, +41.22.372.92.92, marc.blondon@hcuge.ch
- Recruiting
Ospedale Regionale di Lugano
Lugano
Pietro Gianella, MD, 0041.91.811.61.11, pietro.gianella@eoc.ch
About this study
The primary objective is to evaluate and compare the short-term and medicum-term effectiveness of 2 types of interventions in 2 different hospitals to improve the adequacy of hospital thromboprophylaxis among acute medical inpatients.
- Conditions
- Venous Thromboembolism
- Being tested
- Comprehensive electronic tool in the electronic medical chart, Educative sessions, Pocket card
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive electronic tool in the electronic medical chartOther
Use of a comprehensive electronic tool in the electronic medical chart to help the stratification of risk of VTE and the subsequent prescription of an adequate thromboprophylaxis
Educative sessionsOther
Educative sessions on thromboprophylaxis
Pocket cardOther
Pocket card (guide for thromboprophylaxis)
| Study group | Role | What they receive |
|---|---|---|
| Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription | Experimental | Not described Receives: Other: Comprehensive electronic tool in the electronic medical chart; Other: Educative sessions |
| Implementation of educative sessions and pocket cards for thromboprophylaxis | Experimental | Not described Receives: Other: Educative sessions; Other: Pocket card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an adequate thromboprophylaxis
Measured: 90 days
Secondary outcomes (2)
Incidence of venous thromboembolism
Measured: 90 days
Incidence of major bleeding
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc Blondon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Blondon, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306821
- Sponsor's protocol ID
- 2019-01976
- Other IDs
- 2019
- Acronym
- TPX-ENHANCE
- Status last verified
- May 2023
- First submitted
- 2 Feb 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marando M, Blondon K, Darbellay Farhoumand P, Nendaz M, Grauser D, Sallet A, Tamburello A, Pons M, Righini M, Gianella P, Blondon M. Contemporary adequacy of thromboprophylaxis in acutely ill medical patients in Switzerland: a bi-centric prospective cohort. Swiss Med Wkly. 2023 Nov 1;153:40117. doi: 10.57187/smw.2023.40117.
PubMed 37956238
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study
- ClinicalTrials.gov ID
- NCT05306821
- Acronym / sponsor ID
- TPX-ENHANCE / 2019-01976
- Conditions
- Venous Thromboembolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Marc BlondonUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate and compare the short-term and medicum-term effectiveness of 2 types of interventions in 2 different hospitals to improve the adequacy of hospital thromboprophylaxis among acute medical inpatients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription | Experimental | Other: Comprehensive electronic tool in the electronic medical chart, Other: Educative sessions |
| Implementation of educative sessions and pocket cards for thromboprophylaxis | Experimental | Other: Educative sessions, Other: Pocket card |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute medical inpatients hospitalized at the Geneva University Hospitals or the Lugano Regional Hospitals
Key exclusion criteria (4 listed)
- patients already on therapeutic anticoagulation
- patients with an estimated life expectancy of <3 months
- pregnancy
- patients hospitalized for COVID-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive electronic tool in the electronic medical chartUse of a comprehensive electronic tool in the electronic medical chart to help the stratification of risk of VTE and the subsequent prescription of an adequate thromboprophylaxis | Other | Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription |
| Educative sessionsEducative sessions on thromboprophylaxis | Other | Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription, Implementation of educative sessions and pocket cards for thromboprophylaxis |
| Pocket cardPocket card (guide for thromboprophylaxis) | Other | Implementation of educative sessions and pocket cards for thromboprophylaxis |
Primary outcome
Proportion of patients with an adequate thromboprophylaxis
Time frame: 90 days
2 secondary outcomes
Incidence of venous thromboembolism
Time frame: 90 days
Incidence of major bleeding
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 37956238Marando M, Blondon K, Darbellay Farhoumand P, Nendaz M, Grauser D, Sallet A, Tamburello A, Pons M, Righini M, Gianella P, Blondon M. Contemporary adequacy of thromboprophylaxis in acutely ill medical patients in Switzerland: a bi-centric prospective cohort. Swiss Med Wkly. 2023 Nov 1;153:40117. doi: 10.57187/smw.2023.40117.
- Individual participant dataSharing planned: Undecided
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive electronic tool in the electronic medical chart, Educative sessions and Pocket card in people with Venous Thromboembolism, run by Marc Blondon at 2 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an adequate thromboprophylaxis (time frame: 90 days). 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 NCT05306821, 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 10 May 2023.