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Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients

Medication Use Evaluation for Enoxaparin in Hospitalized COVID-19 Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05226793
Enrollment
400
Registered
2022-02-07
Start date
2021-11-17
Completion date
2025-07-22
Last updated
2025-07-28

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

Conditions

Venous Thromboembolism

Brief 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.

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.

Interventions

None listed

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortality with associated DVT or PE2021-2022In-hospital mortality with associated DVT or PE
Length of stay2021-2022Days
Readmissions for DVT and/or PE2021-2022Readmissions for DVT and/or PE
Enoxaparin dose (appropriate for kidney function)2021-2022Enoxaparin dose
Charlson comorbidity index (CCI) score2021-2022(CCI) score
Padua prediction score for risk of VTE2021-2022Padua prediction score
IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score2021-2022IMPROVE \[International Medical Prevention Registry on VTE\] bleeding risk assessment score
ICU status2021-2022ICU status
Number of thromboembolic events2021-2022Number of thromboembolic events

Secondary

MeasureTime frameDescription
Type of bleeding event2021-2022Type of bleeding event
Bleeding events2021-2022Bleeding events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026