A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis (i.e., Preventive Treatment) for Venous Thromboembolism (VTE, i.e., Blood Clots in the Veins) and Bleeding Event Risk in a Population With Acute Medical Illness

A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis for VTE and Bleeding Event Risk in a Population With Acute Medical Illness

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05819112

Enrollment

14799

Registered

2023-04-19

Start date

2023-04-25

Completion date

2023-12-15

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Brief summary

Venous Thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with an increase in risk of mortality and long-term disability and is a major contributor to global disease burden. Participants hospitalized with an acute medical illness are at increased risk of VTE. This study a non-interventional study which analyzes data already collected in the Optum US clinical database. Its aim is to compare conventional versus extended duration prophylaxis with enoxaparin on the incidence of VTE and bleeding events in participants hospitalized for acute medical illness. The first date of enoxaparin treatment will be the index date.

Detailed description

The study population will be developed from the Optum Clinical database in the United States, representing routine clinical practice. Study population will comprise of participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization. The first date of enoxaparin treatment will be the index date. The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Hospitalization for the following acute conditions: * Infection * Respiratory insufficiency * Inflammatory condition * Cancer * Heart failure * Ischemic stroke * Initiation of enoxaparin prophylaxis during hospitalization (index date) * Age ≥40 years

Exclusion criteria

* Symptomatic VTE or major bleeding event 90-days prior to index date * Major surgery within (+1,-90) days from index date * Ongoing anticoagulation therapy (medication supply within \[-2,-32\] days from index date) * Atrial fibrillation * Chronic kidney disease (CKD) stages IV and V, or dialysis The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Design outcomes

Primary

Measure	Time frame	Description
Change in the incidence of VTE, from index date to Day 90	Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.	VTE 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.
Change in the incidence of major bleeding, from index date to Day 90	Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.	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.

Countries

United States

Outcome results