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.

Study Overview

• Status: Recruiting
• Conditions: Venous Thromboembolism

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com
• Study Contact Backup: Name: Zaid Haddadin, MS; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75082
      • Recruiting
      • Methodist Richardson Medical Center
      • Contact: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enoxaparin dose (appropriate for kidney function)	Enoxaparin dose	2021-2022
Charlson comorbidity index (CCI) score	(CCI) score	2021-2022
Padua prediction score for risk of VTE	Padua prediction score	2021-2022
IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score	IMPROVE [International Medical Prevention Registry on VTE] bleeding risk assessment score	2021-2022
ICU status	ICU status	2021-2022
Number of thromboembolic events	Number of thromboembolic events	2021-2022
Length of stay	Days	2021-2022
Readmissions for DVT and/or PE	Readmissions for DVT and/or PE	2021-2022
In-hospital mortality with associated DVT or PE	In-hospital mortality with associated DVT or PE	2021-2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding events	Bleeding events	2021-2022
Type of bleeding event	Type of bleeding event	2021-2022

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Betina Daniel, PharmD, Methodist

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Estimated): November 17, 2024
• Study Completion (Estimated): November 17, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 054.PHA.2021.R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No