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CompletedNCT05226793Updated Jul 28, 2025

Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients

An observational study in Venous Thromboembolism, sponsored by Methodist Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

Retrospective chart review to be conducted at Methodist Richardson Medical Center (MRMC) in Richardson, TX. All adult patients hospitalized with COVID-19 on enoxaparin for DVT prophylaxis will be included. Collected data will be analyzed to determine the safety and effectiveness of the varying enoxaparin doses, and results will be presented at the American Society of Health-System Pharmacists Midyear conference in December 2022.

Read the detailed description

Retrospective chart review to be conducted at Methodist Richardson Medical Center (MRMC) in Richardson, TX. All adult patients hospitalized with COVID-19 on enoxaparin for DVT prophylaxis will be included. Collected data will be analyzed to determine the safety and effectiveness of the varying enoxaparin doses, and results will be presented at the American Society of Health-System Pharmacists Midyear conference in December 2022.

EPIC will be queried for data for this medication use evaluation, including the patient's age, sex, weight/BMI, ICU status, maximum D-dimer level, enoxaparin dose received, development of DVT or PE, incidence and type of bleeding events, readmission status, and mortality. Other patient specific factors such as the CCI score, Padua score, and IMPROVE score will be calculated using online risk assessment tools.

To calculate the CCI score, a search function will be used to analyze the patient's health information in order to determine their age, history of myocardial infarction, congestive heart failure, peripheral vascular disease, stroke or transient ischemic attack, dementia, chronic obstructive pulmonary disease, connective tissue disease, peptic ulcer disease, liver disease, diabetes mellitus, kidney function, cancer status, blood dyscrasias, and HIV status to estimate their 10-year probability of survival.

To calculate the Padua score, each patient must be evaluated for cancer status, history of VTE, mobility status, history of thrombophilic conditions, recent trauma or surgery, age, heart and/or respiratory failure, acute myocardial infarction and/or respiratory failure status, acute infection and/or rheumatologic disorder, obesity, and ongoing hormonal treatment. If a patient scores a 4 or more, then pharmacologic prophylaxis would be indicated.

Lastly, to calculate each patient's bleeding risk, the IMPROVE bleeding risk assessment will be used. For this tool, the patient's age, gender, renal function, liver function, platelet count, ICU status, the presence of a central venous catheter, active gastrointestinal ulcer, history of bleeding in the previous three months, presence of rheumatic disease, and active malignancy are needed to calculate the risk. If the patient scores a 7 or higher on the assessment, they are at an increased risk for bleeding.

02

Conditions studied

  • Venous Thromboembolism
03

In context

Venous Thromboembolism

694 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.

This study's enrollment of 400 is below the median of 700 across 283 observational studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

Methodist Health System is the lead sponsor of 169 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients age 18 years or older hospitalized with COVID-19 on prophylactic/non-therapeutic enoxaparin from January 1, 2021 to January 31, 2021

Patients that do not have any other indication for use of enoxaparin (i.e., active DVT/PE, atrial fibrillation, etc.)

Inclusion criteria

Effectiveness of intermediate-intensity vs standard prophylactic enoxaparin regimens on preventing DVT and/or PE in patients with COVID-19, measured using the following variables:

  • Enoxaparin dose (appropriate for kidney function)
  • Charlson comorbidity index (CCI) score
  • Padua prediction score for risk of VTE
  • IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score
  • ICU status
  • Number of thromboembolic events
  • Length of stay
  • Readmissions for DVT and/or PE
  • In-hospital mortality with associated DVT or PE

Exclusion criteria

Exclusion Criteria:

  • Safety of intermediate-intensity vs standard prophylactic enoxaparin regimens in patients with COVID-19, measured using the following variables:

    • Bleeding events
    • Type of bleeding event
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
400 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Enoxaparin dose (appropriate for kidney function)

    Enoxaparin dose

    Time frame: 2021-2022

  2. Charlson comorbidity index (CCI) score

    (CCI) score

    Time frame: 2021-2022

  3. Padua prediction score for risk of VTE

    Padua prediction score

    Time frame: 2021-2022

  4. IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score

    IMPROVE \[International Medical Prevention Registry on VTE\] bleeding risk assessment score

    Time frame: 2021-2022

  5. ICU status

    ICU status

    Time frame: 2021-2022

  6. Number of thromboembolic events

    Number of thromboembolic events

    Time frame: 2021-2022

  7. Length of stay

    Days

    Time frame: 2021-2022

  8. Readmissions for DVT and/or PE

    Readmissions for DVT and/or PE

    Time frame: 2021-2022

  9. In-hospital mortality with associated DVT or PE

    In-hospital mortality with associated DVT or PE

    Time frame: 2021-2022

Secondary outcomes

  1. Bleeding events

    Bleeding events

    Time frame: 2021-2022

  2. Type of bleeding event

    Type of bleeding event

    Time frame: 2021-2022

07

Study locations

1 site
  • Methodist Richardson Medical Center
    Richardson, Texas 75082, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05226793
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Feb 7, 2022
Start date
Nov 17, 2021
Primary completion
Jul 22, 2025
Completion
Jul 22, 2025
Last update
Jul 28, 2025

Study contacts

Betina Daniel, PharmD
principal investigator · Methodist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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