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

Sanofi

Status: Terminated

Conditions: Venous Thromboembolism

Study type: Observational

Funder types: Industry

Identifiers

NCT05819125

U1111-1288-8394 (Registry Identifier)

CEF0112

Details and patient eligibility

About

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.

Full description

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

Enrollment: 21,000 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medical Patients: Hospitalization due to:

  • Heart failure
  • Ischemic stroke
  • Respiratory insufficiency
  • Infection
  • Inflammatory diseases
  • Active cancer

• Surgical Patents: Following surgery types:

  • Orthopedic
  • Thoracic
  • Abdominal/Pelvic

• Other inclusion criteria:

  • Initiation of enoxaparin prophylaxis (index date)
  • Age ≥ 40 years
  • Body Mass Index (BMI) ≥ 30

Exclusion criteria

• VTE or bleeding event during or 3 months prior to index date
• Surgery within 3 months prior to and up to two days following index date
• Atrial fibrillation
• Antiplatelet or anticoagulation therapy within [-32, -2] days before index date
• Chronic Kidney Disease (CKD) stages IV and V, or dialysis
• Pregnancy

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial design

21,000 participants in 4 patient groups

Conventional prophylaxis

Description:

Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving conventional (i.e., 40 mg once daily for 7 days) enoxaparin VTE prophylaxis

High dose prophylaxis

Description:

Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving high dose enoxaparin for the conventional VTE prophylaxis duration

Extended duration prophylaxis

Description:

Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving the conventional enoxaparin dose for an extended VTE prophylaxis duration

High dose and extended duration prophylaxis

Description:

Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving high dose enoxaparin for an extended VTE prophylaxis duration