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

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

Official Title
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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

Conditions
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Venous Thromboembolism

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional prophylaxis<br>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<br>Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving high dose enoxaparin for the conventional VTE prophylaxis duration | |
| Extended duration prophylaxis<br>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<br>Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving high dose enoxaparin for an extended VTE prophylaxis duration | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the incidence of symptomatic VTE, from index date to Day 90 | The VTE endpoint is intended to represent a new onset symptomatic VTE event. It will be identified in the proposed database by utilizing an algorithm based on the International Classification of Disease 10th and 9th revisions (ICD-10 and ICD-9) codes. | Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date. | 
| Change in the incidence of major bleeding, from index date to Day 90 | The major bleeding event will be identified via an algorithm based on the International Classification of Disease-10th revision and 9th revision (ICD-10 and ICD-9) codes. | Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date. |