TPX-ENHANCE: Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study

• Sponsor: Marc Blondon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05306821
• Collaborator: (none)
• Enrollment: 600
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 52
• Patients Per Site: 300
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Other: Comprehensive electronic tool in the electronic medical chart; Other: Educative sessions; Other: Pocket card	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription	Other: Comprehensive electronic tool in the electronic medical chart; 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; Other: Educative sessions; Educative sessions on thromboprophylaxis
Experimental: Implementation of educative sessions and pocket cards for thromboprophylaxis	Other: Educative sessions; Educative sessions on thromboprophylaxis; Other: Pocket card; Pocket card (guide for thromboprophylaxis)

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with an adequate thromboprophylaxis [90 days]

Secondary Outcome Measures

1. Incidence of venous thromboembolism [90 days]

2. Incidence of major bleeding [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• acute medical inpatients hospitalized at the Geneva University Hospitals or the Lugano Regional Hospitals

Exclusion Criteria:

• patients already on therapeutic anticoagulation

• patients with an estimated life expectancy of <3 months

• pregnancy

• patients hospitalized for COVID-19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva University Hospitals	Geneva		Switzerland
2	Ospedale Regionale di Lugano	Lugano		Switzerland

Sponsors and Collaborators

• Marc Blondon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marc Blondon, Principal Investigator, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT05306821
• Other Study ID Numbers: 2019-01976
• First Posted: Apr 1, 2022
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thromboembolism; Venous Thromboembolism

Study Results

No Results Posted as of Apr 1, 2022