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Completed

NCT Number: NCT05226793

Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Richardson Medical Center

Richardson, Texas, 75082, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. Enoxaparin dose (appropriate for kidney function)

    Time frame: 2021-2022

    Enoxaparin dose

  2. Charlson comorbidity index (CCI) score

    Time frame: 2021-2022

    (CCI) score

  3. Padua prediction score for risk of VTE

    Time frame: 2021-2022

    Padua prediction score

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

    Time frame: 2021-2022

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

  5. ICU status

    Time frame: 2021-2022

    ICU status

  6. Number of thromboembolic events

    Time frame: 2021-2022

    Number of thromboembolic events

  7. Length of stay

    Time frame: 2021-2022

    Days

  8. Readmissions for DVT and/or PE

    Time frame: 2021-2022

    Readmissions for DVT and/or PE

  9. In-hospital mortality with associated DVT or PE

    Time frame: 2021-2022

    In-hospital mortality with associated DVT or PE

Secondary outcomes

  1. Bleeding events

    Time frame: 2021-2022

    Bleeding events

  2. Type of bleeding event

    Time frame: 2021-2022

    Type of bleeding event

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2022
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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