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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-25

Study Completion Date

2023-12-15

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.

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Detailed Description

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

Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Conventional prophylaxis

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

No interventions assigned to this group

High dose prophylaxis

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

No interventions assigned to this group

Extended duration prophylaxis

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

No interventions assigned to this group

High dose and extended duration prophylaxis

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

No interventions assigned to this group

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

* 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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No