NCT05819125

Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin

Comparison of the Risk of Venous Thromboembolism and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis With Enoxaparin

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 21,000 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

In individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs) focusing specifically on this population. Evidence suggests that in obese participants, both higher dosing and duration of VTE prophylaxis with Low Molecular Weight Heparins (LMWH) may be required to achieve a therapeutic effect similar to non-obese participants. This non-interventional study utilizes data already collected from a usual clinical practice setting in the Optum US clinical database, representing obese participants hospitalized with an acute medical condition or undergoing surgery receiving enoxaparin prophylaxis. Its aim is to compare the impact of the following enoxaparin prophylaxis strategies on the incidence of symptomatic VTE and major bleeding in the overall study population and prespecified subgroups: * High versus conventional dose * Extended versus conventional duration * Combined High-Dose and Extended-Duration versus Conventional-Dose and Conventional-Duration. The first date of enoxaparin prophylaxis will be the index date.

Detailed description

The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.

Conditions

• Venous Thromboembolism

Timeline

• Start date: 2023-04-25
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2023-04-19
• Last updated: 2024-10-29

Locations

1 site across 1 country: United States